Clinton choice for VP signed Virginia bill to mandate HPV vaccine for 6th grade

Rhode Islanders against mandated HPV vaccinations does not endorse any particular presidential candidate, but when the potential Vice President finds it acceptable to mandate Gardasil……. then we feel you need know that. If he is okay with bypassing your parental rights of choice for something that can not impact the classroom; then how well will your parental rights be respected in over all retrospect? Hillary Clinton accepts more money in her campaign from pharmaceutical companies then any other candidate. You need to vote for what you feel is the best choice, just as you need to choose what is the best choice for your family to get the Gardasil vaccine or not.

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Clinton chose Virginia Senator Tim Kaine. Kaine has a history of sinister idealogy. In fact, he once forced sixth grade girls to take Gardasil shots, according to a 2007 article from the Washington Post. (see below)

In 2006, Kaine accepted  $12,000 from Teva Pharmaceuticals TEVA, +0.18% to cover his expenses at the Democratic Governors Association meeting. A third of his donations come from big banks, or “securities and investments.” In Virginia, accepting gifts from special interest is considered a non-issue. 

“During his eight years as lieutenant governor and governor, Sen. Kaine went beyond the requirements of Virginia law, even publicly disclosing gifts of value beneath the reporting threshold,” a spokesperson told Politico. “He’s confident that he met both the letter and the spirit of Virginia’s ethical standards.”

According to CBSNews.

The disclosures showed he received an $18,000 Caribbean vacation from Virginia-based tech investor James Murray, Jr., and in 2007 received $5,500 in clothing from Stuart Siegel of S&K Menswear, a company that declared bankruptcy in 2009. Teva Pharmaceuticals gave $12,000 for expenses incurred for the Democratic Governors Association meeting in Aspen in 2006. Obama for America had the largest disclosure–$45,075 for travel and lodging related to the 2008 presidential campaign.


Kaine Says He’ll Sign Bill Making Shots Mandatory

By Tim Craig

Washington Post Staff Writer
Saturday, March 3, 2007

RICHMOND, March 2 — Virginia Gov. Timothy M. Kaine said Friday that he has decided to sign legislation requiring all sixth-grade girls to get immunized against a virus that causes cervical cancer if their parents don’t object.

Kaine (D) had expressed “some qualms” this week about mandating that girls receive the human papillomavirus vaccine before entering high school, but he said many of those concerns were alleviated after he studied the bill closer.

“The particular language that ended up in the bill is fine,” Kaine said today. “It’s very broad, and people get information about the health benefits and any health concerns about the vaccination, and they get to make their own decisions. I think that is the right balance.”

Virginia will become the second state to require the vaccine, which is called Gardasil. Last month, Texas Gov. Rick Perry (R) said girls in that state would also be required to receive it. At least 20 states and the District are studying similar proposals.

 New Jersey-based pharmaceutical maker Merck & Co. received federal approval in June to sell the vaccine. Merck began a nationwide lobbying campaign to try to get states to mandate the vaccine. Merck suspended its campaign two weeks ago amid questions about whether profit, instead of public health, is guiding the debate.

In Virginia, parents will be able to opt out of the requirement without citing a reason.

“If they choose not to do it, they don’t have to do it,” said Del. Phillip A. Hamilton (R-Newport News), the sponsor of the legislation. “They just have to sign a form so the health department knows they opted out.”

HPV is a sexually transmitted virus that causes almost 7,000 cases of cervical cancer annually. A federal study released Wednesday estimated that 7.5 million girls and women ages 14 to 24 have been infected with the virus.

Because the virus is transmitted through sexual contact, some parents and politicians worry that mandating the vaccine might encourage promiscuity. But a bipartisan majority in the General Assembly voted overwhelmingly in favor of the mandate.

The bill would take effect in 2008, making the 2008-09 school year the first that girls would be required to receive the vaccine. Supporters said that provides officials enough time to study side effects.

NACCHO HPV Stance – a statement from a group you’ll wish didn’t exist.

NACCHO HPV Stance – a statement from a group you’ll wish didn’t exist.

NACCHO HPV Statement of Policy

Below you will read, what you will not believe. The recent HPV mandate proposal in a PA county….. well this might have been some motivation. #InformedConsent becomes a job for parents and patients everywhere. Is this how it should be? The only way to stop the mandates and the infringements on our civil rights is to take the job around informed consent seriously. Do NOT stop asking questions, do NOT believe everything your doctor tells you. Much of what they are taught was a paid for message or something that comes down from a group or organization they trust, one they may not have investigated the motives or money trail of. Please read below in full, and be on the look out for what this group could encourage in the future.

 


STATEMENT OF POLICY

Increasing HPV Vaccination Rates in Males and Females

Policy

The National Association of County and City Health Officials (NACCHO) supports strong coordination, collaboration, and communication among public health, healthcare providers, parents and caregivers, and community partners at the local, regional, state, and federal levels to increase human papillomavirus (HPV) vaccination coverage in both males and females according to the recommendations of the Advisory Committee on Immunization Practices (ACIP). Local health departments should implement and adapt programs and policies to increase vaccination rates in their communities.

NACCHO encourages local health departments to develop a comprehensive approach to increasing HPV vaccination rates that includes the following:

Encouraging providers to make strong and consistent HPV vaccine recommendations and educating them on the most effective way of communicating these recommendations;

 Supporting communication campaigns to educate parents and caregivers about the importance of HPV vaccination for cancer prevention and encouraging parents and caregivers to vaccinate their children;

 Educating adolescents directly about HPV and other adolescent health issues;

 Developing relationships with non-traditional vaccine providers such as pharmacists and expanding their role in increasing HPV vaccination rates;

 Developing relationships with adolescent health groups, hospital systems, healthcare and cancer coalitions, school systems, and provider groups to support HPV vaccination;

 Developing, using, and sharing best practices to increase HPV vaccination rates and close the gap between male and female vaccination rates;

 Reducing missed opportunities and increasing HPV vaccine series completion through assessment and system-based changes using tools such as AFIX, reminder/recall, standing orders, and Immunization Information Systems;

 Implementing evaluation and data collection processes to demonstrate the impact of HPV vaccine promotion initiatives;

 Seeking opportunities to address systemic barriers to vaccination such as health inequity and a lack of access to healthcare; and

 Establishing themselves as trusted sources of information about HPV and other vaccines in their community.

Local health departments should consider developing or maintaining the capacity to bill third-party payers for the vaccine and administration to ensure long-term programmatic sustainability.

NACCHO also encourages continued state and federal support of local health department efforts to establish HPV initiatives, sustain program activities, and collaborate with public health partners.

Justification

HPV is the most common sexually transmitted infection in the United States and is responsible for nearly 26,000 new cases of cancer each year. HPV infections are responsible for the majority of cervical cancer and have been increasingly linked to cancers of the anus, penis, throat, vagina, and vulva.1,2 The combined cost of HPV-associated cancers and other conditions is estimated to be $8 billion per year in the United States.3

Immunization has proven to be one of the most effective and safest public health interventions available. In 2006, ACIP recommended the HPV vaccine for routine vaccination of adolescent females between ages 11–12.4 In 2011, ACIP expanded the recommendation to include adolescent males.5 Although the President’s Cancer Panel considers HPV vaccination a top priority in cancer prevention, coverage rates remain significantly low and fall short of the Healthy People 2020 target of 80% for both males and females.6,7 According to 2013 National Immunization Survey data, 57.3% of females and 34.6% of males received at least one dose of HPV vaccine compared to 86% for tetanus, diphtheria, and pertussis (Tdap) and 77.8% for meningococcal conjugate vaccines. This demonstrates both the disparity between male and female vaccination rates and the feasibility of high adolescent vaccine coverage.8,9

However, providers often miss opportunities to vaccinate adolescents during routine healthcare visits as evidenced by the fact that nearly two-thirds of 11–12 year olds are not vaccinated for HPV at office visits where they receive other vaccines.10 If these missed opportunities were avoided, approximately 93% of 13- to 17-year-old females would have at least initiated the series by 2012.11 Healthcare provider peer-to-peer education can be effective in overcoming challenges for the collective uptake of adolescent vaccines; therefore, it may be useful in reducing missed opportunities and encouraging providers to make a strong recommendation. This is especially important since a physician’s recommendation is the strongest predictor of HPV vaccination among adolescents.12, 13

Increasing access to healthcare may also lead to increased HPV vaccination rates since adolescents with health insurance and high healthcare utilization are associated with higher vaccination coverage.14 Misinformation about HPV and the HPV vaccine are pervasive in many communities, which can be overcome through effective communication campaigns. Racial disparities also exist in HPV vaccination coverage, as lower rates of series completion have been shown in African-American females compared to other groups15; thus addressing systemic issues such as health inequity may help increase vaccination rates.

Resources for Local Health Departments from NACCHO’s HPV Prevention Project

NACCHO’s first cohort of ten local health departments are implementing their action plans to identify strategies to improve HPV vaccination rates. Read these local health departments’ stories to learn about their ongoing HPV prevention efforts:

Additionally, NACCHO’s Guide to HPV Resources for Local Health Departments assists local health departments with increasing HPV vaccination rates. This collection of fact sheets, webinars, infographics, print material, videos, and more can assist local health departments with the development of HPV projects and vaccination campaigns. Download the Guide

 

References:

1. International Agency for Research on Cancer. (2007). Monographs on the evaluation of carcinogenic risks to humans. Volume 90: human papillomaviruses. Lyon, France: World Health Organization, International Agency for Research on Cancer.

2. Gillison, M.L., Alemany, L., Snijders, P.J., Chaturvedi, A., Steinberg, B.M., Schwartz, S., et al. (2012). Human papillomavirus and diseases of the upper airway: Head and neck cancer and respiratory papillomatosis. Vaccine, 30(5 Suppl.), F34-54.

3. Chesson, H.W., Ekwueme, D.U., Saraiya, M., Watson, M., Lowy, E.R., & Markowitz, L.E. (2012). Estimates of the annual medical costs of the prevention and treatment of disease associated with human papillomaviruses in the United States. Vaccine, 30(42), 6016-9.

4. Markowitz, L.E., Dunne, E.F., Saraiya. M., Lawson, H.W., Chesson, H., & Unger, E.R. (2007). Quadrivalent human papillomavirus vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 56(RR-2), 1-24.

5. CDC. (2011). Recommendations on the use of quadrivalent human papillomavirus vaccine in males — Advisory Committee on Immunization Practices (ACIP), 2011. Morbidity and Mortality Weekly Report, 60(50), 1705-8.

6. National Cancer Institute. (2014). Accelerating HPV vaccine uptake: Urgency for action to prevent cancer. A report to the President of the United States from the President’s Cancer Panel. Retrieved April 4, 2014, from http://deainfo.nci.nih.gov/advisory/pcp/annualReports/HPV/index.htm

7. Department of Health and Human Services. Healthy People 2020 webpage. Retrieved January 6, 2015, from http://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases

8. CDC. (2014). Human papillomavirus vaccination coverage among adolescents, 2007–2013, and postlicensure vaccine safety monitoring, 2006–2014 — United States. Morbidity and Mortality Weekly Report, 63(29), 620-4.

9. Elam-Evans, L.D., Yankey, D., Jeyarajah, J., Singleton, J.A., Curtis, C.R., MacNeil, J., et.al. (2014). National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 Years — United States, 2013. Morbidity and Mortality Weekly Report, 63(29), 625-33.

10. Stokley, S., Cohn, A., Jain, N., & McCauley, M.M. (2011). Compliance with recommendations and opportunities for vaccination at ages 11 to 12 years: Evaluation of the 2009 national immunization survey-teen. Archives of Pediatrics & Adolescent Medicine, 165(9), 813-8.

11. CDC. (2013). Human papillomavirus vaccination coverage among adolescent girls, 2007-2012, and postlicensure vaccine safety monitoring, 2006-2013—United States. Morbidity and Mortality Weekly Report, 62(29), 591-5.

12. Gargano, L.M., Herbert, N.L., Painter, J.E., Sales, J.M., Morfaw, C., Rask, K., et al. (2013). Impact of a physician recommendation and parental immunization attitudes on receipt or intention to receive adolescent vaccines. Human Vaccines & Immunotheraputics, 9(12), 2627-33.

13. Reiter, P.L., McRee, A.L., Pepper, J.K., Gilkey, M.B., Galbraith, K.V., & Brewer, N.T. (2013). Longitudinal predictors of human papillomavirus vaccination among a national sample of adolescent males. American Journal of Public Health, 103(8), 1419-27.

14. Kessels, S., Marshall, H., Watson, M., Braunack-Mayer, A., Reuzel, R., & Tooher, R. (2012). Factors associated with HPV vaccine uptake in teenage girls: A systematic review. Vaccine, 30, 3546-56.

15. Curtis, C.R., Dorell, C., Yankey, D., Jeyarajah, J., Chesson, H., Saraiya, M., et. al. (2014). National human papillomavirus vaccination coverage among adolescents aged 13-17 years — National Immunization Survey — Teen, United States, 2011. Morbidity and Mortality Weekly Report, 63(2), 61-70.

Record of Action

Proposed by NACCHO Immunization Workgroup

Adolescent Health Beyond Borders

Adolescent Health Beyond Borders

Adolescent Health Insider

Adolescent Health Beyond Borders

July 2016


Roughly 1.8 billion adolescents and young adults between the ages of 10 and 24 live in today’s world, representing the largest generation of adolescents in human history. These young people face never-before-seen shifts in populations, economies, technology, health, and the environment. The benefits of helping today’s adolescents navigate these shifts and develop into healthy adults extend to future generations.

In recognition of the critical need to support adolescents, The Lancet Commission on Adolescent Health and Wellbeing released a report on the current state of adolescent health around the world, and the challenges and opportunities for addressing it. Below are some key findings from the report.

Defining Adolescence

Why Should We Focus on Adolescence?

In the United States, early childhood is widely recognized as a critical developmental period, but adolescence garners far less attention, despite its importance in establishing adult health and stability. During the teen and young adult years, the tremendous physical and mental changes that adolescents undergo prime them for creating their own lives beyond their families. While timing and appearance vary, adolescents pass key milestones on the road to adulthood, including completing education, finding a job, and establishing romantic partnerships and/or other social connections.

As the phase in life directly preceding adulthood, adolescence has large and immediate impacts not only on young people themselves, but future generations. Today’s adolescents are the next in line to fill the workforce and create families. Through their development and completion of milestones, adolescents build and acquire the health, financial independence, and social capital that they will use not only in their adult lives but that they will pass on to their children. Taking action for adolescent health now ensures the health of future generations.

What Does Adolescent Health Look Like Today?

The increasing number of adolescents is partly related to advances in health and medicine, particularly in eliminating infectious diseases. However, this progress has not spread evenly across the globe, and as a result, countries have radically different adolescent health profiles.

The Lancet Commission categorized the global burden of disease into three categories, each with their own challenges:

  • About one third of adolescents (661 million) live in non-communicable disease (NCD) predominant countries. Most high-income countries fall into this category, including the United States. The top adolescent health issues are related to mental and substance use disorders (e.g., depression, tobacco use) and chronic physical diseases (e.g., diabetes).
  • Roughly one in eight adolescents (219 million) lives in an injury excess country, where unintentional injury and violence are the primary causes of disability and death.
  • Half of all adolescents (917 million) live in multi-burden countries, where both injury and NCDs are a major concern along with infectious disease, malnutrition, and other conditions related to poverty. Most of the countries in Africa fall into this category, along with India and its neighbors, and several Southeast Asian island nations.

Additionally, wide variation may exist within particular countries. For example, four of China’s provinces could be classified as injury excess, even though the country is classified as NCD prominent overall.

Health is also influenced by varied social and structural factors known as the social determinants of health. While a number of social determinants impact adolescents, The Lancet Commission specifically identifies four: family, peers, education/employment, and the media. What these determinants look like and how they affect health are rapidly changing, creating unprecedented challenges and opportunities for adolescent health.

While the adolescent health issues facing countries and localities differ, all communities can take action to support adolescent health and development.

What Can We Do to Promote Adolescent Health?

Addressing the health needs of today’s adolescents can seem like a daunting task, but there are several key opportunities that offer hope. In particular, guaranteeing and supporting adolescents’ ability to access and complete their secondary education has been named as the single best investment for their health and well-being. Other opportunities identified by the Commission include addressing preventable and treatable adolescent health conditions (e.g., HIV/AIDS, injury, infectious diseases) and establishing systems that train, mentor, and encourage the participation of youth health advocates that make health care more responsive to adolescents’ needs.

The report points out that the most powerful actions for adolescent health cut across sectors and include multiple components. OAH’s national call-to-action, Adolescent Health: Think, Act, Grow® (TAG), seeks to foster this multi-level, multi-sectoral collaboration. You can use the TAG action steps to support adolescent health in your work.

Over the next four OAH Picks, OAH will delve further into The Lancet‘s primary social determinants of health affecting adolescents, how they relate to the outstanding opportunities for adolescent health, and tools that youth-serving professionals and others can use to promote adolescent health.

Motor and sensory clinical findings in girls vaccinated against the human papillomavirus from Carmen de Bolivar, Colombia.

Motor and sensory clinical findings in girls vaccinated against the human papillomavirus from Carmen de Bolivar, Colombia.

Lengthy post. #NOHPVmandateRI

Colombia

Original research

By Pompilio Martinez, MD
Alumnus, School of Medicine, National University of Colombia
Ex-investigator, Colombian National Institute of Health, Bogota, Colombia


Abstract

Here I describe neurological symptoms of 62 girls who were immunized against the human papilloma virus (HPV). Most participants (61) are Colombian and received the quadrivalent HPV vaccine Gardasil and a girl from Mexico received the bivalent Cervarix vaccine. The average age was 14.5 years (SD 2.1). This survey reveals an overall pattern of peripheral nervous system damage as demonstrated by complaints of inflammatory and neuropathic pain syndromes in the head, back, chest, arms and legs. There were also sensory and motor syndromes with upper and lower limb numbness and tingling (paraesthesia), muscle weakness and difficulty walking (paresis) accompanied by tremors, muscle spasms and twitches (abnormal movements). Most symptoms appeared after the second vaccine dose, which agrees with greater antibody titers seen in booster dose immunizations. A…

View original post 7,972 more words

How to Nip HPV Vaccine Mandates in the Bud: Lessons from Pennsylvania

From PA. #NOHPVmandateRI #NOHPVmandatePA

jameslyonsweiler.com

ACBH

MANY OF MY FELLOW sojourners on Facebook have thanked me for fighting back at the – read this slow – proposal to write a proposal for a mandate for HPV vaccination in Allegheny County, PA that the Allegheny County Board of Health (ACBH) was contemplating.  While it’s true I’ve been involved the spotlight really goes to the ladies of the local contingent of the Pennsylvanian Coalition for Informed Consent and the members of the general public who stood up and said #nohpvmandatePA.

I was invited to participate in a meeting w/these truth warriors and defenders of health rights, and I can attest that no board, no committee, no legislative body will ever succeed in mandating HPV in the Pennsylvania as long as they have to deal with this coalition.  They are organized, informed, dedicated, and, most importantly, growing.

My personal experience in this is consistent with my own growing awareness…

View original post 3,199 more words

Awareness Campaign~ counter RI Dept of Health

Awareness Campaign~ counter RI Dept of Health

The RI Dept of Health recently sent out postcards direct to minors and also robo called homes of 7th and 8th grade parents in regards to vaccinations. Some calls were for multiple vaccines and some focused on the HPV vaccine. None of this effort gave risks vs benefits data or disclosed exemption options.

You can read our press release about this topic by clicking HERE ==> PRESS RELEASE. Help bring attention to this matter by posting this press release direct at media accounts. The more that show they are not happy about this the more the media might pay attention. Hashtag #NOHPVmandateRI

 


We are working to counter the efforts of the Dept of Health with informed consent via our Awareness Campaign. They have over a half million dollars to which they can delegate to different forms of marketing. We don’t need that much to still be loud and keep citizens informed.

Our current goal is $2500, If you give $8 or $80 or $800 it makes a BIG difference. Help with whatever amount you are able. 100 people giving $25 puts us at our goal. This is not just a RI issue, this is a national issue. RI reports the strategies to the National Vaccine Advisory Committee, along with their % of vaccinated children in the age range. NVAC is already advocating for minor consent without parental consent of the HPV vaccine, we need to show that we can and we WILL fight back. The nation leaders need to know that mandating HPV vaccines on any level anywhere in the USA is not acceptable.

Please donate today donate-now-heart-speech-bubble_138893771

This is very important issue on so many levels.

  • Mandating a vaccine for a disease that does not impact the classroom
  • Marketing direct to minors for medical procedures
  • Calling homes with automated messages, for a vaccine that this state has one of the highest vaccination rates in the country.
  • Neglecting informed consent

The RI Dept of Health has never been challenged by the public like we have done in the last year. They stepped up their efforts, we need to STAND UP STRONG. It is time to put them on the Defense. The more you give the more we can do.

donate_now_button

 

 

 

We sent out an email that it seems many may not have received, you can find that message here, if you didn’t get a message recently.

Follow on Twitter @MyRightsRI

Tax Dollars Used To Market Controversial HPV Vaccine Mandate

Tax Dollars Used To Market Controversial HPV Vaccine Mandate

Subject: Tax Dollars Used To Market Controversial HPV Vaccine Mandate

PRESS RELEASE for Immediate Release

JULY 5, 2016

Rhode Islanders against mandated HPV vaccinations (#NOHPVmandateRI) calls out the RI Dept, of Health

Recently, the RI Dept. of Health began robo-calls to households of children entering the seventh and eighth grade urging students to get vaccinations. This call outlines that HPV (human papillomavirus) is a dangerous disease. In never mentions that most cases of HPV are asymptomatic and that 90% of all cases clear themselves within two years. It does not inform that there are religious exemptions available for vaccinations in Rhode Island. Rhode Islanders against mandated HPV vaccinations (#NOHPVmandateRI)

The Dept. of Health doubled their efforts with postcards. Each one was sent in the name of the student and was marketing vaccinations. Direct health decision information mailed and marketed to minors. When did it become appropriate to bypass the parent for a medical procedure? Why is proper informed consent not being utilized? Why is there no mention of the religious or medical exemptions?

In 2014, the same year the vaccine was mandated, the RI Dept. of Health received a grant for the HPV vaccination of over $638,000. The grant money line item breakdown shows that none of the money is to purchase the vaccine or to subsidize the vaccine cost. The grant for over a half million dollars is to market one specific vaccination. Federal grant money, our tax dollars, was awarded in this large sum to the smallest state in the nation. So far none of their efforts have included risks vs benefits, which is essential to any medical procedure, or that Rhode Island has exemptions for parents. They have not yet returned a phone call from a group member, to determine if the grant was part of the National Vaccine Advisory Committee test market campaign of 2014.

“This marketing to minors is completely inappropriate,” says Aimee Gardiner, Director of #NOHPVmandateRI. “I do not feel it is a good use of tax dollars, to increase a push on vaccination especially for a vaccine this state already shows a high rate of students have received. It is concerning that a Dept that is supposed to be dedicated to Health and well-being does not respect informed consent, and then crosses into marketing at minors.”

“Parents are upset, and they have every right to be” Christine Waldeck of Providence adds. “I find it appalling that the automated call ends with ‘vaccines are safe, and vaccines work’, they are not one size fits all, some kids are seriously injured as evidenced by the billions of dollars in payouts to families from the National Vaccine Injury Compensation Program.”

Rhode Islanders against mandated HPV vaccinations strongly encourages anyone not fully comfortable with receiving the HPV vaccination to file a religious exemption form. The RI HPV Info pack has the exemption form included, it is located at www.RIHPVinfo.nohpvmandateri.com

 

Media Contact

Aimee Gardiner, Director

Rhode Islanders against mandated HPV vaccinations

admin@nohpvmandateri.com ~ 4014062647

PDF file of press release

Safety & Immunogenicity of GlaxoSmithKline’s HPV Vaccine in Female Children

Safety & Immunogenicity of GlaxoSmithKline’s HPV Vaccine in Female Children

This study is currently on going. Test completion expected November 2016. Children ages 4-6 yrs old are being tested to receive Cervarix by GSK.

  Purpose

The current study will evaluate the immunogenicity and safety of Cervarix when administered according to a 2-dose schedule with or without co-administration of GSK Biologicals’ MMR and DTPa vaccines in 4-6 years old female subjects as compared to the standard 3-dose schedule in 15-25 years old female subjects, the population in which the clinical efficacy has been demonstrated.


Trial record 11 of 266 for:    HPV children

Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus Vaccine in Healthy Female Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01627561
First received: June 14, 2012
Last updated: March 10, 2016
Last verified: February 2016
  Purpose

The current study will evaluate the immunogenicity and safety of Cervarix when administered according to a 2-dose schedule with or without co-administration of GSK Biologicals’ MMR and DTPa vaccines in 4-6 years old female subjects as compared to the standard 3-dose schedule in 15-25 years old female subjects, the population in which the clinical efficacy has been demonstrated.
Condition Intervention Phase
Infections, Papillomavirus Biological: Cervarix
Biological: Priorix
Biological: Infanrix
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:

  • Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. [ Time Frame: During the 7-day period (Days 0-6) following each vaccination ] [ Designated as safety issue: No ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.


  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 7-day period (Days 0-6) following each vaccination ] [ Designated as safety issue: No ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.


  • Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs). [ Time Frame: During the 43-day period (Days 0-42) post vaccination Dose 1 ] [ Designated as safety issue: No ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.


  • Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs). [ Time Frame: During the 30-day period (Days 0-29) post vaccination Dose 2 at Month 6 ] [ Designated as safety issue: No ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.


  • Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters. [ Time Frame: 42 days post dose 1 (PRE) and at 30 days post dose 2 (POST) ] [ Designated as safety issue: No ]
  • Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters [ Time Frame: 42 days post dose 1 (PRE) and at 30 days post dose 2 (POST) ] [ Designated as safety issue: No ]
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7) ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


  • Number of Subjects With AEs and SAEs Leading to Withdrawal [ Time Frame: From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7) ] [ Designated as safety issue: No ]
  • Number of Subjects With Potential Immune-mediated Diseases (pIMDs) [ Time Frame: From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7) ] [ Designated as safety issue: No ]
  • Number of Subjects With Medically Significant Conditions (MSCs) [ Time Frame: From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7) ] [ Designated as safety issue: No ]
  • Number of Serconverted Subjects for Anti-HPV-16 [ Time Frame: One month after the last dose of study vaccine (Month 7) ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.


  • Number of Serconverted Subjects for Anti-HPV-18 [ Time Frame: One month after the last dose of study vaccine (Month 7) ] [ Designated as safety issue: No ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.


  • Anti-HPV-16 Antibody Titers [ Time Frame: One month after the last dose of study vaccine (Month 7) ] [ Designated as safety issue: No ]
    Antibody titres were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).


  • Anti HPV-18 Antibody Titers [ Time Frame: One month after the last dose of study vaccine (Month 7) ] [ Designated as safety issue: No ]
    Antibody titers were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).


Secondary Outcome Measures:

  • Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Group MMR_DTPa [ Time Frame: At Day 0, Month 7 and Month 12 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Group MMR_DTPa [ Time Frame: At Day 0, Month 7 and Month 12 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D. [ Time Frame: At Day 0 and Months 7, 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D. [ Time Frame: At Day 0 and Months 7, 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-Based Neutralization Assay (PBNA) in a Sub-cohort in Group MMR_DTPa [ Time Frame: At Day 0, Month 7 and Month 12 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Group MMR_DTPa [ Time Frame: At Day 0, Month 7 and Month 12 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D. [ Time Frame: At Day 0 and Months 7, 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D. [ Time Frame: At Day 0 and Months 7, 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-measles, Mumps and Rubella Seropositivity Rates in Groups HPV_2D, MMR_DTPa and HPV_2D CO. [ Time Frame: On Days 0 and 42 ] [ Designated as safety issue: No ]
  • Anti-measles, Mumps and Rubella Antibody Titres in Groups HPV_2D, MMR_DTPa and HPV_2D CO. [ Time Frame: On Days 0 and 42 ] [ Designated as safety issue: No ]
  • Vaccine Response Rates to Filamentous Haemagglutinin (FHA), Pertactin (PRN) and Pertussis Toxoid (PT) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO. [ Time Frame: At Month 7 ] [ Designated as safety issue: No ]
  • Seroprotection Rates to Diphtheria (D) and Tetanus (T) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO. [ Time Frame: At Month 7 ] [ Designated as safety issue: No ]
  • The Number of Subjects With Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism, Including Febrile Convulsion [ Time Frame: During the 43-day period (Days 0-42) following vaccination on Day 0 ] [ Designated as safety issue: No ]
  • The Occurrence of pIMDs in All Groups. [ Time Frame: From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12) ] [ Designated as safety issue: No ]
  • The Occurrence of MSCs in All Groups. [ Time Frame: From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12) ] [ Designated as safety issue: No ]
  • The Occurrence of SAEs in All Groups. [ Time Frame: From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12) ] [ Designated as safety issue: No ]
  • The Occurrence of SAEs Related to the Investigational Products, to Study Participation, to GSK Concomitant Products or Any Fatal SAE in All Groups. [ Time Frame: Throughout the study period (From Day 0 to Month 36) ] [ Designated as safety issue: No ]
  • The Occurrence of AEs/SAEs Leading to Withdrawal in All Groups. [ Time Frame: Throughout the study period (From Day 0 to Month 36) ] [ Designated as safety issue: No ]
  • The Occurrence of Pregnancy and Pregnancy Outcomes in Group HPV_3D. [ Time Frame: From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting the Intake of Concomitant Medication [ Time Frame: During the 43-day period (Days 0-42) following vaccination on Day 0 and during the 30-day period (Days 0-29) following vaccination at Month 6 ] [ Designated as safety issue: No ]
  • The Number of Subjects Completing the Vaccination Schedule in All Groups. [ Time Frame: From first vaccination to the last vaccine dose (from Day 0 up to Month 6) ] [ Designated as safety issue: No ]
Enrollment: 149
Study Start Date: October 2012
Estimated Study Completion Date: November 2016
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group

Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Biological: Cervarix

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6 in the HPV_2D and HPV_2D CO Groups 3 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0, Month 1 and Month 6 in the HPV_3D Group
Other Name: HPV
Experimental: Priorix + Infanrix Group

Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Biological: Priorix

1 dose administered intramuscularly in the deltoid muscle of the left/right arm at Day 0
Other Name: MMR

Biological: Infanrix

1 dose administered intramuscularly in the deltoid muscle of the left/right arm at Month 6
Other Name: DTPa
Experimental: HPV_2D CO group

Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine, the first dose co-administered with Priorix vaccine (at Day 0) and the second one co-administered with Infanrix vaccine (at Month 6)
Biological: Cervarix

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6 in the HPV_2D and HPV_2D CO Groups 3 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0, Month 1 and Month 6 in the HPV_3D Group
Other Name: HPV

Biological: Priorix

1 dose administered intramuscularly in the deltoid muscle of the left/right arm at Day 0
Other Name: MMR

Biological: Infanrix

1 dose administered intramuscularly in the deltoid muscle of the left/right arm at Month 6
Other Name: DTPa
Active Comparator: HPV_3D group

Subjects aged 15-25 years receiving 3 doses of Cervarix vaccine at Day 0, Month 1 and Month 6
Biological: Cervarix

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6 in the HPV_2D and HPV_2D CO Groups 3 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0, Month 1 and Month 6 in the HPV_3D Group
Other Name: HPV

Detailed Description:

The study will be conducted in a partially blinded manner:

  • The study will be single-blind for the HPV_2D and MMR_DTPa groups up to the Month 12 visit due to the difference in the visual appearance of the study vaccines. Between Month 12 and study conclusion (Month 36), the study will be open with respect to HPV_2D group.
  • The study will be open with respect to the HPV_2D CO group as subjects in this group will be receiving two vaccines co-administered at each scheduled vaccination visit.
  • The study will be open with respect to the HPV_3D group as subjects in this group will be receiving three injections.
  Eligibility

Ages Eligible for Study: 4 Years to 25 Years   (Child, Adult)
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

All subjects in the 4-6 years age groups must satisfy ALL the following criteria at study entry:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A female between, and including, 4 and 6 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects who received four doses of DTP vaccine (i.e., three doses in the first year of life and a fourth dose in the second year of life) according to the schedule applicable in the participating countries.
  • Subjects who received a first dose of MMR vaccine according to the schedule applicable in the participating countries.

All subjects in the 15-25 years age group must satisfy ALL the following criteria at study entry:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol and subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
  • A female between, and including, 15 and 25 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to enrolment in the study. For subjects below the legal age of consent, written informed consent has to be obtained from the parent(s)/LAR(s) of the subject and, in addition, the subject should sign and personally date a written informed assent.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

For all groups:

  • Child in care.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s). Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza and/or poliomyelitis vaccines up to 8 days before the first dose of study vaccine(s) is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
  • History of any reactions or hypersensitivity likely to be exacerbated by any component of the study vaccines, including latex and/or obvious allergic reactions to neomycin, egg protein, etc.
  • Cancer or autoimmune disease under treatment.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous administration of MPL or AS04 adjuvant.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine(s) or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • Documented human immunodeficiency virus (HIV)-positive subject.
  • Major congenital defects or serious chronic illness.
  • History of seizures or serious neurological disorder, which, according to the judgment of the investigator, precludes administration of any of the study vaccines.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine(s).
  • Acute disease and/or fever at the time of enrolment.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose(s).

Additional exclusion criteria for subjects in the 4-6 years age groups only:

  • Previous administration of the fifth dose of DTP vaccine and/or the second dose of MMR vaccine or planned administration of DTP vaccine and/or MMR vaccine outside the study.
  • History of tetanus, diphtheria, pertussis, measles, mumps and/or rubella.
  • Known exposure to diphtheria or household exposure to pertussis within 30 days prior to vaccination with DTPa.
  • Known exposure to measles, mumps and/or rubella 30 days prior to vaccination with the MMR study vaccine.
  • Confirmed or suspected tuberculosis.
  • Severe allergic reactions following the administration of previous dose(s) of DTP or MMR vaccines.
  • Hyperpyrexia (≥ 40.5°C) within 48 hours of administration of previous doses of DTP or MMR vaccines.
  • Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of administration of previous doses of DTP vaccine.
  • Collapse or shocking-like state within 48 hours of administration of previous doses of DTP vaccine.
  • Idiopathic thrombocytopenic purpura or bleeding disorders.
  • Additional exclusion criteria for subjects in the 15-25 years age group only: Pregnant or breastfeeding.
  • A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627561

Locations
Colombia
GSK Investigational Site
Bogota, Colombia, 38007
GSK Investigational Site
Yopal, Casanare, Colombia
Mexico
GSK Investigational Site
Mexico, Mexico, 04530
Panama
GSK Investigational Site
Panama, Panamá, Panama
GSK Investigational Site
Panama, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01627561     History of Changes
Other Study ID Numbers: 115887  2011-005604-15
Study First Received: June 14, 2012
Results First Received: April 23, 2015
Last Updated: March 10, 2016
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Keywords provided by GlaxoSmithKline:

Immune response
Human papillomavirus
HPV vaccine
Safety

Additional relevant MeSH terms:

Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 30, 2016

The Acceptability of the HPV Vaccine Postpartum

The Acceptability of the HPV Vaccine Postpartum

This study is to get women who are not yet 26 but are pregnant to accept the Gardasil vaccination during postpartum. To have the pediatrician recommend the vaccine for the mother during the young child’s well visits.

Wonder if they will also inform that the package for Gardasil states that it is not suggested for breastfeeding mothers?

Follow our blog for more info too


Trial record 9 of 266 for:    HPV children

The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kimberly Kilfoyle, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02602626
First received: November 5, 2015
Last updated: June 7, 2016
Last verified: November 2015
  Purpose

The purpose of this study is to determine if women would find it acceptable to receive the HPV vaccine postpartum at the pediatrician’s office at the time of their child’s two-month well- child visit when offered during the third trimester of pregnancy.
Condition
Vaccination
Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:

  • Acceptability of HPV vaccination [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]
    Estimation of the proportion of women indicating that they would be willing to receive the HPV vaccine postpartum at pediatric well-child visits if offered in the third trimester of pregnancy


Secondary Outcome Measures:

  • Proportion of women attending postpartum visits [ Time Frame: At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment. ] [ Designated as safety issue: No ]
    Estimation of the proportion of women who attend postpartum visits with their obstetric care providers


  • Estimate of baseline prevalence of prior HPV vaccination in study population [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Participants eligible for participation based on maternal age and gestational age will be screened for prior doses of HPV vaccine by self-report. Number of participants with self-report of prior HPV vaccination will be recorded and baseline prevalence from our population will be determined.


Other Outcome Measures:

  • Attitudes and beliefs regarding HPV immunization [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    This will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale


  • Health Literacy [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Health literacy will be screened using the “Newest Vital Sign” Measure


  • HPV and HPV vaccine Knowledge [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    A series of questions will be used to determine baseline knowledge of HPV and HPV vaccination


Enrollment: 600
Study Start Date: November 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Detailed Description:

There are a large number of young adult women who have not received any doses of HPV vaccine or are incompletely vaccinated. Recommendation for HPV vaccine could occur during pregnancy with the administration of the vaccine postpartum. Finding a way to make it easy for women to present for vaccination is imperative as this is currently a 3-vaccine series. The investigators are interested in understanding if women would find it acceptable if the investigators discussed and encouraged the vaccine while pregnant with receipt of the vaccine through their child’s pediatrician at well-child visits in the postpartum period. The investigators will survey women in the third trimester of pregnancy to determine if they would find this acceptable and follow-up with them after their child’s two month pediatric visit to reevaluate their opinion. No doses of the vaccine will be given.

The investigators are also interested in understanding other factors that could affect whether or not women would be interested in receiving the HPV vaccine postpartum. This includes rates of attendance at postpartum visits as well as behavioral, knowledge and demographic characteristics that may be associated with acceptability of receiving the vaccine.

  Eligibility

Ages Eligible for Study: 18 Years to 26 Years   (Adult)
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population
Women will be recruited from the hospital based UNC Obstetric and Gynecology (UOG) Clinic including the resident clinic, faculty clinics and maternal fetal medicine clinics. The UOG Clinic cares for a diverse population of women from the immediate geographical area as well as referrals from 14 surrounding funded health centers.
Criteria

Inclusion Criteria:

  • Pregnant women at 28 weeks of gestational age or greater

Exclusion Criteria:

  • Primary language other than English or Spanish
  • Receipt of any prior doses of HPV vaccine.

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02602626

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Kimberly Kilfoyle, MD University of North Carolina, Chapel Hill
Study Chair: Lisa Rahandale, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Kimberly Kilfoyle, MD, Clinical Instructor and Teaching Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02602626     History of Changes
Other Study ID Numbers: 14-2178  5T32HD040672-15
Study First Received: November 5, 2015
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:

Human Papillomavirus
HPV
Postpartum

ClinicalTrials.gov processed this record on June 30, 2016

HPV vaccine about to be tested in children as young as 1yr old

HPV vaccine about to be tested in children as young as 1yr old
Children ages 1-17yrs old are being considered for a test market of the HPV vaccine for respiratory papillomatosis. According to the Centers for Disease Control and Prevention, the incidence of RRP is rare. Fewer than 2,000 children get RRP each year.
Below is the actual copy of information directly from the clinical trials website.
This study has not started yet.
If you look it says eligible participants are as young as 1yr of age, however the test administer is for infants from 0 to 6months???…..
Please keep up to date as much as you are able. There are so many government sites to keep track of and so much information from every direction. The government agencies do not play well with the concept of informed consent so there is no easy way to locate all the information you wish to dig up and research.
Follow this blog to keep up with HPV related information and the RI mandate of the HPV vaccine.

Trial record 2 of 266 for:    HPV children

4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by National Institute of Child Health, Hungary
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary
ClinicalTrials.gov Identifier:
NCT01995721
First received: November 20, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted

  Purpose

Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.

After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

Condition Intervention Phase
Recurrent Respiratory

Papillomatosis

Biological: 4-valent

HPV vaccine

Phase 3
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children
Resource links provided by NLM:
Further study details as provided by National Institute of Child Health, Hungary:

Primary Outcome Measures:

  • Papilloma relapses [ Time Frame: 18 months after the 3rd vaccine ] [ Designated as safety issue: No ]
    Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18–months follow-up period


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4-valent HPV vaccine

4-valent HPV vaccine administered in months 0., 2., 6.
Biological: 4-valent HPV vaccine

Vaccination with 4-valent HPV vaccine in months 0., 2., 6.

Other Names:

  • Silgard
  • Gardasil

Detailed Description:

  1. Enrollment
    • ear-nose-throat (ENT) examination + oesophagoscopy
    • immunological assessment
      • assessment of selected humoral (antibodies) and
      • cellular immune response parameters(INF gamma and granzyme B testing)
      • in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
  2. Immunization with 4-valent HPV vaccine at 0,2,6 months
  3. Follow up
    • 1 month after 3rd vaccine dose – immunological assessment (same tests as in the enrollment phase)
    • 6, 12 and 18 months after the 3rd vaccine dose – ENT + oesophagoscopy

  Eligibility

Ages Eligible for Study: 1 Year to 17 Years   (Child)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • respiratory papillomatosis
  • at least 3 relapses in patient history
  • HPV 6 and/or 11 positive papillomas
  • able to mount neutralizing antibodies

Exclusion Criteria:

  • other chronic underlying condition
  • other HPV type
  • no antibody response

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995721

Contacts
Contact:

Zsofia Meszner, MD, PhD

+36 1 365 1540 zmeszner@gmail.com

Locations
Hungary
National Institute of Child Health Not yet recruiting
Budapest, Hungary, 1113
Contact: Zsofia Meszner    +36 1 365-1540    zmeszner@gmail.com
Principal Investigator: Zsofia Meszner, MD, PhD
Sponsors and Collaborators
National Institute of Child Health, Hungary
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Zsofia Meszner, MD, PhD National Institute of Child Health

  More Information

Responsible Party: dr. med habil Zsófia Meszner PhD, Professor, National Institute of Child Health, Hungary
ClinicalTrials.gov Identifier: NCT01995721     History of Changes
Other Study ID Numbers: 50934
Study First Received: November 20, 2013
Last Updated: November 20, 2013
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by National Institute of Child Health, Hungary:

recurrent respiratory papillomatosis
human papillomavirus
vaccine
treatment
immunology
relapse

Additional relevant MeSH terms:

Papilloma
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 30, 2016