HPV Vaccines: Betrayal of the Public Trust?

HPV Vaccines: Betrayal of the Public Trust?

In 2013 multiple news articles reported 44% of American parents refusing Gardasil or Cervarix for their children. Between 2008 and 2010, the percentage of parents concerned about the safety of these two vaccines nearly quadrupled. As of 2010, only 32% of eligible girls were vaccinated against HPV. What is wrong with this picture?

Excerpts from national news sources, March 18-22, 2013:

  • USA Today The percentage of parents who say they won’t have their teen daughters vaccinated against the human papillomavirus increases, even though physicians increasingly recommend the vaccinations. Concerns about safety and side effects for the human papillomavirus (HPV) vaccine have increased among parents: 16% cited these fears as the main reason they did not have their daughters vaccinated in 2010, up from 5% in 2008…
  • Medpage Today Parents increasingly say they are worried about the safety of the human papillomavirus (HPV) vaccine and don’t intend to vaccinate their teen daughters… But there is no similar pattern for two other vaccines aimed at adolescents…
  • CNN Health Concerns of mothers and fathers about the safety of the HPV vaccine grew each year, from 4.5% in 2008 to 16.4% in 2010… The number of parents who said they would not vaccinate their children for HPV increased from 38.9% in 2008 to 43.9% in 2010. The main concern was safety.
  • CBS News One of the main reasons parents said they didn’t want their children vaccinated against HPV was because of safety concerns.
  • Bloomberg The number of girls who received either injection (Gardasil or Cervarix) rose to about one-third in 2010 from 16 percent in 2008…
  • FiercePharma A growing share of U.S. parents say they won’t vaccinate their daughters… And that leaves Merck’s Gardasil and GSK’s Cervarix with a shrinking market.
  • The New York Timessuggesting, the need for interventions beyond clinical recommendations like possibly ‘state and federally designed social marketing campaigns.’… Without brushing aside the need to address safety concerns, the increasing rates of HPV vaccine refusal suggest that widespread vaccination will require more than marketing campaigns. Medical professionals need to look for ways to tell a better story to parents and teens about HPV, vaccination and cancer. (emphasis added)

Taxpayer funded social marketing campaigns? Look for ways to ‘tell a better story’ to parents? Who are these people kidding? What happened to investigative journalism? What happened to fact-finding? What happened to fair and balanced journalism?

Has no one considered the possibility that the 43.9% of parents refusing this particular vaccine might have some valid concerns? When will people realize there is a huge difference between ‘increasingly concerned about the safety’ and ‘increasingly aware of the potential risks’? After all, this would not be the first time a prescription medication approved by the FDA as ‘safe and effective’ turned out to be nothing of the sort. Will HPV vaccines be next?

HPV vaccination programs worldwide are based on two assumptions. First, HPV vaccines will prevent cervical cancer and save lives. Second, HPV vaccines will pose no risk of serious side effects. Therefore, it would make sense to vaccinate as many pre-adolescent girls as possible to reduce the worldwide burden of cervical cancer. What happens if both of these assumptions are not based on factual evidence?[1]

Medical Consumers Want to Know:

  1. Since HPV vaccines have never been shown to prevent cervical cancer, why are they being promoted as cervical cancer vaccines?1
  2. Since the majority of HPV infections and a great proportion of abnormal lesions associated with cervical cancer development clear spontaneously without medical treatment, how can these factors be used as ‘end-points’ during clinical trials to reliably predict the number of cervical cancer cases that could be prevented by HPV vaccines?1
  3. How can the clinical trials make an accurate estimate of the risk associated with HPV-vaccines if they are methodologically biased to produce false negatives?1
  4. Why are HPV vaccines marketed so aggressively in developed countries, when 85.5% of annual cervical cancer cases and 87.9% of annual cervical cancer deaths occur in developing countries?[2]
  5. How can passive adverse event monitoring systems (voluntary reporting with no penalty for failure to report), such as those used by most vaccine surveillance systems world-wide, allow the medical regulatory agencies to make accurate estimates on the real frequency of HPV-vaccine related adverse reactions?
  6. How can accurate estimates of the real frequency of HPV-vaccine related adverse reactions be made if appropriate follow-up and thorough investigations of suspected vaccine reactions are not conducted?

The FDA granted Merck’s HPV vaccine, Gardasil, fast track approval in June of 2006, despite the fact that this HPV vaccine failed to meet the FDA criteria for fast track approval.[3] FDA approval of GSK’s HPV vaccine, Cervarix, followed shortly after in January 2007.

According to The New York Times, the CDC Advisory Committee on Immunization Practices recommended adding HPV vaccines to the immunization schedule in the U.S. despite the fact that 64% of the advisory committee members had potential conflicts of interest which were either never disclosed or left unresolved at the time they voted. 3% of the members actually voted on matters they had been barred from considering by ethics officers. News like this certainly does little to enhance the level of public trust.

Is it possible for the FDA to objectively monitor the safety and efficacy of HPV vaccines? One has to wonder since Congress tightened the rules on outside consulting after similarly undisclosed conflicts of interest were discovered within advisory committees at the FDA.

As if this is not enough, the United States Department of Health and Human Services, via the National Institutes of Health, Office of Technology Transfer receives royalties on each HPV vaccine sold worldwide. This happens because technologies used in the production of HPV vaccines were developed at NIH and subsequently patented by them. For three of the last five years, HPV vaccines based on recombinant papillomavirus capsid proteins have ranked #1 based on royalties from product sales.[4]

Marketing Gardasil to the public under these circumstances is a typical case of unconstrained government self-dealing. The major patent holder (National Cancer Institute/NCI), the regulator (FDA) and the vaccination policy maker (CDC) are all divisions of the Department of Health and Human Services (DHHS). These self-dealings typically benefit some administrators, not the government or tax payers.  For example, Dr. Julie Gerberding, as the Director of the CDC, approved the use of Gardasil for cervical cancer prevention as a public health policy is now the president of Merck’s Vaccine division promoting the sales of Gardasil.

How much revenue is generated for the NIH from international sales of HPV vaccines? In November 2010, Dr. Eric Suba submitted a Freedom of Information Request to the Office of Government Information Services to discover the amount. It seems the financial details of the partnership between the NIH, Merck and GlaxoSmithKline are exempt from disclosure. (Read the response received here.) Apparently, transparency in government does not apply to the top 20 revenue producing patent(s) developed at taxpayer expense. Why is the public not allowed to share in celebrating the success of products they financed?

Three Strikes for Gardasil?

  1. September 2011: Recombinant HPV DNA L1 gene DNA fragments, possibly attached to the aluminum adjuvant, were discovered in 100% of Gardasil samples tested. There was no subsequent investigation. The FDA simply declared the ‘expected’ presence of residual DNA is not a safety factor. No documentation was provided. The fact that HPV vaccines were approved by governments worldwide based on manufacturers’ assertions that the vaccines contained ‘no viral DNA’ was completely ignored.[5], [6] The possibility of recombinant HPV DNA fragments being attached to aluminum adjuvant particles was also ignored.
  2. August 2012: One of the antigens used in Gardasil was discovered in central nervous system samples from two girls who died after being vaccinated with Gardasil. No cause of death was identified upon autopsy in either case.[7] HPV-16 L1 gene DNA fragments of vaccine origin apparently attached to aluminum adjuvant particles were also discovered in post mortem blood and spleen samples of a girl who died 6 months after Gardasil injections.[8], [9]
  3. February 2013: It was discovered that the naked HPV 16 L1 gene fragments bound to aluminum particles by ligand exchange in Gardasil have acquired a non-B conformation. This conformational change may have stabilized the HPV 16 gene fragments in Gardasil preventing their normal enzymatic degradation in vaccine recipients.[10], [11] Non-B DNA conformations and their relationship to diseases has been studied since the 1960’s. Based on current scientific knowledge, the human genetic consequences of these non-B DNA structures are approximately 20 neurological diseases, approximately 50 genomic disorders and several psychiatric diseases.[12], [13] The impact of injected foreign non-B DNA on human health is totally unknown. 

Why have none of these discoveries sparked a single investigation in any country? Why is no one concerned when genetically modified viral DNA fragments are found in vaccines that are reported to have no viral DNA? Why is no one worried about those viral DNA fragments being attached to aluminum (a known toxin) possibly creating a new chemical compound of unknown toxicity? Why are no red flags raised when those viral DNA fragments attached to aluminum acquire a non-B conformation – something known to be associated with multiple debilitating diseases? Anyone with an ounce of common sense should demand to know why those charged with approval, recommendation and safety monitoring of these vaccines appear to be utterly unconcerned about the future health implications of any one of these discoveries, much less all three of them.

What kind of ‘expert’ advice is being given to YOUR government health officials?

Israel’s Advisory Committee on Infectious Diseases and Inoculations held a teleconference on 30 January 2013, to discuss the proposed introduction of HPV vaccines into the country’s school inoculation program among other issues. The official transcript of that meeting, dated 11 February 2013, provides some interesting insights for medical consumers who question HPV vaccine safety.

Ron Dagan, MD, is Professor of Pediatrics and Infectious Diseases at the Ben-Gurion University of the Negev in Beer-Sheva, Israel, and Director of the Pediatric Infectious Disease Unit at the Soroka University Medical Center, also in Beer-Sheva. An active researcher and international lecturer, Dr. Dagan’s work focuses on new conjugate vaccines. His expert advice to Israel’s Advisory Committee regarding potential HPV vaccine implementation is as follows (translation provided-emphasis added):

We are dealing with injections, some of which given in 3 [separate] doses, which are delivered to teenage girls. Many side effects are to be expected. During the week following the vaccine delivery of the injections many serious events which are not related/linked to the vaccination are expected: fainting, deaths and convulsions/fits. This needs to be taken into account. Even if it is not rational, if these events happen in class they may damage the general perception/status of the vaccinations. This is happening all over the world all the time. We have already dealt with a similar issue in relation to the delivery of MMR with TD and Polio and we have accepted the nurse’s proposal to split these between grades 1 and 2. The nurses are suitable to make recommendations to the committee in relation to this issue. In relation to the side effects, we need to be prepared in advance and not simply react after the fact. I propose we consult with the English representatives as to how they’ve gone about this. We must prepare for the delivery of the new vaccine. The nurses need to know they are going about this in the way they are most comfortable with (/have the most control over/familiarity with).

If this is an example of the expert advice vaccination programs are based on, it’s no wonder medical consumers are questioning HPV vaccine safety, efficacy and need. Many side effects are to be expected? Fainting, deaths, convulsions and fits occurring during the week following vaccination – yet not related to the vaccine? Preparing in advance for side effects? Consulting with other countries to see how they handled the problem? Are countries around the world being offered similar expert advice?

So, what will it take to solve the HPV vaccine uptake problem?

Parental concerns about HPV vaccine safety are not going to go away in response to social media campaigns. Teaching medical professionals to ‘tell a better story’ is not going to make parents change their mind about Gardasil, Cervarix, or any future HPV vaccine. Platitudes and unsubstantiated reassurances are no longer sufficient.

The time has come for government health authorities to make HPV vaccine manufacturers prove their claims or pull their products from the market. Medical consumers want scientifically proven facts – Safe, Affordable, Necessary and Effective – nothing less is acceptable.


The above article is from SaneVax.org and was written in 2013. This information is still valid and a reminder is in order for the current fight for our rights around the country and in RI about the HPV vaccine. #InformedConsent is essential and very important points are not being disclosed.

Since this article was published, last month there was a change in the dosing scheduled suggestions by the CDC. Where children under age 15 only need to receive two doses vs three doses. More specific details also apply.

Now on Nov 18th the CDC will hold a training to teach health care workers how to encourage the HPV vaccine and how to understand the new dosing recommendations by the CDC from Oct 2016.

Share this blog post with your legislator and schedule a time to sit down and speak with them.

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