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



RI Dept of Health sends postcards about vaccines directly to 11 & 12 yr olds

RI Dept of Health sends postcards about vaccines directly to 11 & 12 yr olds

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These postcards have been sent out addressed directly to the 7th and 8th grade students.

Do you find this acceptable? Do you want the RI Dept of Health direct mailing your children? Please comment and let us know your thoughts.

 

Sign the petition to reverse the mandate of the HPV vaccination and advocate for informed consent.

DONATE NOW to fight against the hundreds of thousands that the RI Dept of Health has at its disposal. Informed Consent is everyone’s right and our priority, please help us today.

Allegheny County considers mandate for HPV vaccine for students

 hpv-vaccine

After 35 radiation treatments and seven chemotherapy sessions to reduce a cancerous lump in his throat from the human papillomavirus HPV, John Rhodes had trouble eating, swallowing and communicating.

For a time, he needed a feeding tube, and he has yet to put on the 80 pounds he lost as a result. As assistant coach for the Duquesne men’s basketball team, he had to use other tactics to get his players attention so he could teach them without the booming voice he used to have.

Mr. Rhodes, 50, expressed his support for the HPV vaccine at the Allegheny County Health Department’s public forum on Wednesday night. The forum was meant to gather community input about the possibility of requiring all adolescents be vaccinated against HPV.

“As a coach and a very competitive person, I challenge all of you to encourage more people to get vaccinated,” Mr. Rhodes told the crowd.

Karen Hacker, director of the Allegheny County Health Department, said the department would compile the information from community members and present it at the next board meeting on July 13. If the board decides to move forward with the mandate, Dr. Hacker said there will be time for public comment then. The health department is also discussing the possibility of requiring school nurses to report vaccination coverage for the HPV vaccine.

The HPV vaccine includes three shots over a period of six months and is meant to protect against genital warts, throat and mouth infections, and a host of cancers. The virus is a sexually transmitted disease and affects nearly 80 million people in the United States, according to data from the Centers for Disease Control and Prevention.

Following CDC guidelines, the mandate would require 11- and 12-year-olds to receive all three doses of the HPV vaccine in a certain period of time to be admitted to school.

Currently, the Pennsylvania Department of Health requires children to have one dose of meningococcal conjugate vaccine and one dose of Tdap (tetanus, diphtheria, acellular pertussis) before entering seventh grade. State guidelines, which Dr. Hacker said the mandate would follow, allow students with moral, religious or medical concerns to be exempt. Dr. Hacker did not know of any other Pennsylvania counties considering such a mandate.

The vaccine is recommended at 11 or 12 so the child is protected before they come in contact with someone with the virus and because the vaccine has a stronger immune response in younger children, according to Karen Feinstein, CEO of the Jewish Healthcare Foundation, which leads an HPV vaccination initiative. If children are not yet vaccinated, the CDC recommends vaccination for females aged 13-26 and males aged 13-21.

In Pennsylvania, 48.2 percent of females between 13 and 17 years old and 26 percent of males received all three shots in 2014, according to CDC data. In the Pittsburgh region, 27 percent of girls and 21.8 percent of boys ages 14-17 were fully vaccinated in 2014, according to the Jewish Healthcare Foundation.

Although the HPV vaccine protects against several strands of the virus, James Lyons-Weiler, founding director for the Institute for Pure and Applied Knowledge, said it does not target the rarer types of the virus. A mandate for the vaccine, he said, could cause a larger problem.

“The rarer kind sweeps in and replaces more common types. They’re rare because they’re more dangerous, more deadly,” he said. His only solution would be to wait until there is a program that protects against all types of HPV and to have better training for doctors administering the vaccine.

In the United States, the Rhode Island Department of Health began requiring the vaccine for seventh-grade students in September 2015, and several other states are considering legislation. Some other countries, though, have not had successful results from mandates for the HPV vaccine, which Alison Mullins, co-director for the Pennsylvania Coalition for Informed Consent, said is a red flag.

“This is a vaccine that is available to anyone, anyone who wants it can get it at any time. Why do we need to mandate something that we know has serious issues and that other countries have ceased mandating,” Ms. Mullins said.

She recommends people read the package insert on vaccines to learn about potential adverse effects. Gardasil, for example, she said, listed unexplained collapse, seizure, stroke and death on the package insert.

 

There is a quiz located at the bottom of the original article asking if the HPV vaccine should be mandated.

Fill in form to support reversing the HPV vaccine mandate in RI and advocating for informed consent.

Common Sense RI

Common Sense RI


Patricia Morgan Interviews Aimee Gardiner on the HPV vaccine mandate in RI

Common Sense RI also takes a look at some of the political points at the state house.

Like Common Sense RI facebook page to see all their episodes.

 

 

Today is the last day

Today is the last day that VaxXed documentary will be shown in RI. Avon Cinema on Thayer St, Providence RI. Showing at 4:25p & 8:25p
See the press release here vaxxed.nohpvmandateri.com
Join the VaxXed team newsletter and follow along with what they are doing as this documentary works towards bringing awareness in Congress.

Christine Waldeck has about a dozen T Shirts and is located in Northern RI and Aimee Gardiner has about 25 T Shirts and is in Southern RI. If you are looking to purchase a VaxXed T Shirt they are $20 each and you can email changehpvmandateri@gmail.com with your preference of meeting in Providence area or Washington County area and we will connect with you. The Vaxxed T Shirt sales support the producers traveling to many locations to promote and discuss the film with the Q & A sessions. You can also connect with both women in the Facebook discussion group .

Do you have a review of the Vaxxed documentary? We would love for you to email your review to us, or create a 2minute or less video of yourself. Hope to hear from you and what your thoughts are soon.
Now that Vaxxed will be leaving RI and the summer is just kicking off with many parents getting their HPV mandate letters in the mail, we will be re-launching the Awareness Campaign. You can help by copy and pasting the below statement on social media.

RI schools are sending home letters stating that the HPV vaccine is mandated for school attendance (7th & 8th). This notice gives no mention of the religious exemption in most cases. RI Dept of Health publicly stated that no child will be left out of school for not receiving the HPV vaccine. Please know that this vaccine is not a requirement that has no options. RI HPV Info pack is available to provide information and to get a copy of the religious exemption. RIHPVinfo.nohpvmandateri.com #NOHPVmandateRI #InformedConsent

We are working towards our goal of $700 to print 15000 rack cards to spread throughout RI, to give parents and citizens the information they have a right to know. Will you help us get there? Any amount helps. www.gifts.nohpvmandateri.com

Thank you for the support of advocating for informed consent and working to reverse the mandate of the HPV vaccine in RI.

Sincerely,

Rhode Islanders against mandated HPV vaccinations team.

RI VaxXed Review; Julie

On Sun, Jun 18 2016, 10:21pm Julie wrote:

I just returned home after seeing the first showing of VaxXed in Rhode Island.  It was everything I expected and more simply because I have been desperately researching the maladies my children have been suffering from for the last 14 years. I haven’t been looking for someone to “blame”, I’ve simply wanted to know “what happened” to my kid and “why”.  I don’t want money and I don’t want revenge. I’ve only sought to make my children’s lives healthier so they can pursue the “normal” path into adulthood and enjoy all the great things that I have experienced as someone who grew up in the 70’s and 80’s. Well, those days are behind us in every way.  I had the chicken pox and survived. I even had a small case of shingles in my late 30’s and survived that as well. When I was 18 months old, I was quarentined in the hospital for something I can’t even remember. No permanent damage. Had I been vaccinated for any of those diseases? No.  I’m a healthy grown adult today with 3 boys who are suffering from A to Z……..
The documentary “VaxXed : From Cover-up to Catastrophe” answers the two questions that I have been most interested in hearing answers for.
First, how does any of this Autism link to MMR theory make sense when our esteemed doctors are sworn to take an oath of “First, do no harm”? This is a whole can of worms on its own and I won’t go into it in my review of VaxXed. The long and short of it is that the Hippocratic Oath doesn’t really “say” this. Good lord you say? Yes, really. I will post a few links about that later.
Second, how can we not believe or trust the Pediatricians that are so wonderful to our babies? They love babies! They have their own babies!  They would NEVER harm our children. I believe this. The startling truth that VaxXed shows us is that our beloved Pediatricians have been LIED TO and an alarming number of them have no idea they are being lied to even to this day!  That is a fact.
That is why when we walk into our doctors office with our babies and ask “could this horrible symptom be because he had that shot on the very same day etc…..” we get the “No, of course not, the CDC sent us the literature with all the studies proving that this shot is safe and necessary….”
So there it is, the stark and infuriating truth.

Here are a few bullet points I thought were worth listing:

*You will most likely cry at some point during this film, so plan accordingly.
*People are bringing their children to this film. This is a good thing. Children should be informed, the younger the better.  Kids will chat a little about what they are seeing. Let’s give them a pass within reason, they will likely spread the word to their friends.
*I had 2 moms behind me completely break down at different times and they had the ability to get up and take a breather.  They returned a few minutes later. Please have patience for those who are outwardly crying. We can always see this film again if a few words were missed.
*A few people were shocked by some actual congressional testimony shown regarding the CDC cover up. They had a few words to say “out loud” to the movie screen. We empathize, we’ll give them a pass.
*At the end of the movie, in the credits, some good information is listed. People will take pictures of the screen with their phones for future reference. I think this is absolutely a circumstance for one to be able to use their phone in the theater.

Lastly, I can’t believe we are here, in this age, having to learn that this horrible crime has been perpetrated on our children. We must continue the battle to educate everyone we meet. We’ll be bullied and belittled. I certainly have been. But to plant the seed is the beginning and we will reach some people. Those people will reach a few as well……..and so on…….

Love to you all.

I have to add another paragraph to my VAxXed review. It wouldn’t be a truly honest review if I didn’t correct one thing.  I asked my mom late last if she remembered what I had been quarantined for. Here is her copied text back to me:

You had a high fever so dad took you to hospital. You had had your smallpox vaccination several days before that and a fever was a typical reaction. Yours was quite high so Dr Jane Had you admitted. You got diarrhea just when you were coming home so we’re quarantined for couple days.

So there you go. I, too, have been vaccine injured. The irony would be enjoyable if vaccine injury had ceased 45 years ago. Alas, it continues today.

Playing in RI at Avon Cinema June 17-23rd, 4:25p & 8:25p


Wrongly injected toddler fights leukaemia

BLINDSIDED: Ryan and Keri Topperwien with Chace, who is battling a rare form of leukaemia.
A Hamilton toddler who was mistakenly injected with a vaccine to prevent cervical cancer when he was just six weeks old has developed a rare form of leukaemia.

Chace Topperwien began chemotherapy for the M7 strand of acute myeloid leukaemia on his second birthday last month, but doctors cannot tell them whether the Gardasil vaccine he was injected with in May 2009 caused the cancer.

His parents, Ryan and Keri Topperwien, are devastated at the diagnosis after they were reassured at the time of the incident that their baby would not suffer any adverse reactions.

“I had thought in the very back of my mind that the absolute worst thing they could say is leukaemia,” Mrs Topperwien said. “When they said that he had it, it blindsided both of us.”

The couple, both 27, were horrified when at six weeks old their son was given the vaccination meant for teenage girls instead of one to prevent meningitis.

Gardasil targets the human papillomavirus, which causes warts on the hands, feet and genitals and is responsible for 99 per cent of cervical cancers.

Since the cancer diagnosis, Chace has been undergoing an aggressive course of chemotherapy treatment for up to 10 hours a day in Starship hospital in Auckland.

The little boy is due to start a second course of chemotherapy on Tuesday but doctors are waiting for his white blood cell levels to increase.

Until then the once energetic and outdoor-loving preschooler is confined to his bedroom 23 hours a day while his immune system recovers – a simple cold or bug could be disastrous.

The couple said their only child was taking the illness in his stride and, other than a nasogastric tube in his nose for feeding, looked deceivingly well.

“He’s still smiling and laughing. Other than not being allowed out of his room he’s still happy. But he knows that he’s not well.”

Mr Topperwien has taken indefinite leave from his job as a ceiling installer and Mrs Topperwien has put her PhD studies on hold so they can be at their son’s bedside.

The pair, who are sleeping at Ronald McDonald House and take turns spending the night with Chace, have taken a three-month “mortgage holiday” to keep financial pressures at bay.

But they are worried about what will happen when that ends and said if Chace’s chemotherapy was not successful they might need to look at further treatment overseas.

To help the family, friends have started three Facebook pages to raise money and so far fundraising events have netted more than $4000. A head-shaving fundraiser planned for tonight in Hamilton had attracted up to 20 participants, Mr Topperwien said.

He and his wife had already shaved their own hair to show Chace, whose hair had begun falling out, that it was okay to have it shaved off.

Meanwhile they want their concerns about a possible link between the Gardasil vaccination mistake and Chace’s leukaemia acknowledged. “It’s not a crazy theory,” Mrs Topperwien said.

“We feel the development of his immune system has been interrupted and when he was diagnosed doctors said that the mutation of his cells had come about through a different pathway to the way leukaemia normally develops.”

Waikato District Health Board medical officer of health Dr Felicity Dumble said she did not believe there would be a link between Gardasil and leukaemia.

However, she said it was important cases such as Chace’s be monitored and researched to establish if there was a possible association.

Read the original article post here

Follow the blog and get updates on the HPV mandate in RI

Good Afternoon June 16th

Good Afternoon June 16th

The day is upon us and the VaxXed documentary is debuting tomorrow. This is very exciting to be able to show this in Rhode Island and have the legislators that are our elected officials have the option to view it right here and see this important information. Aimee & Christine went to the State House this week and personally invited members of the General Assembly to attend this film and see the data it provides.

This message may be a little longer then our average email and we sincerely request you to read the entire message to have all the content. We want to be sure you have the information we believe you want us to share with you, but this time it is a little more then we usually have in one post/email.

Vaxxed T Shirts will be arriving soon for purchase and if you ordered the NOHPVmandateRI T Shirts you should have already received a shipping status email. The Vaxxed T Shirts will not be available at the Avon Cinema. Rhonda & Aimee will be right around the corner on Saturday the 18th with them available for purchase $20 each. 6pm at Flatbread Pizza on Cushing St. You may also contact Aimee at 401.406.2647 to connect for purchasing the T Shirts. The Vaxxed T Shirt sales support the efforts of the team traveling around the nation to go to different theaters and discuss the film. To see the up to date current Facebook posts about this film in RI; the event page will give you that and you can invite others to join in too.

VaxXed~ Avon Cinema, Thayer St Providence RI. June 17-23rd at 4:25p & 8:25p = Tickets are available for sale at the cinema box office 30-40 minutes before the show time, there is not online sales.

Do you need financial help with getting a ticket? Email BringVaxXedtoRI@gmail.com to inquire about getting a ticket to see VaxXed. Donate for others who may not otherwise be able to attend at www.tinyurl.com/DonateVaxxedTickets

Don’t forget to also sign up for updates through email from VAXXED via http://www.vaxxedthemovie.com selecting the newsletter.

Are you not familiar with the area? See the end of this message for a description of what to expect driving in.

Recently Coalition Radio on WPRO had Del Bigtree on the show. Here is the recording of the interview.
https://www.spreaker.com/embed/player/standard?episode_id=8752501&autoplay=false

Tomorrow June 17th Del Bigtree and Rhonda Apollo will be guests on the CT local TV show Holistic Health Hour. 5-6p est. Atlantic Broadband Channel 25. Be Sure to tune in.

Please email ChangeHPVmandateRI@gmail.com if you are interested in having one of the producers and a representative of our group for an interview.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Rhode Islanders against mandated HPV vaccinations supports this documentary on the basis of informed consent. The citizens of the United States have a right to know the true facts of data about medical decisions, withholding that information negates informed consent. Merck makes Gardasil the HPV vaccine and it also makes the vaccine in the study being manipulated. As an organization we stand against the mandate attached to a child’s education, and we advocate for informed consent. Though we do not take position on the HPV vaccine or any vaccine, informed consent also involves sharing information that is in direct association to our topic. Merck and the CDC are directly connected to the HPV vaccine, we fully support the data in this documentary being available and viewed, and the public can choose how to react or what to do with that data. We will continue to advocate for information and transparency to be a priority.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Saturday June 18th Jim Langevin (congressional representative) will be holding a public open lunch. 12p-2p at Bravo Wood Fired Pizza in North Kingstown. Ask him why he hasn’t obtained the CDC whistle blower documents from Bill Posey’s office. Ask him to attend VaxXed and ask him to take a stand for informed consent in our medical industry. Tell him you are watching, and doing nothing, come November matters on votes. Congress has known about the documents presented in VaxXed for two years. Congressman Bill Posey requested that congress investigate the CDC after he looked over the documents. Jim Langevin along with many others did not even request copies of the documents to look over themselves. Informed Consent matters, transparency in our highest health organization matters. Make sure Jim Langevin knows your stance. Here is the link to his lunch event on Facebook.


Call your representatives and senators and tell them how important this issue is. Whether you just want to focus on discussing the HPV vaccine mandate, or also the CDC whistle blower William Thompson documents. They need to know we are serious and we are watching. Call them today and make your voice heard.

Join us in the discussion online to see others posts and perspectives too.

Donate to our mission of reversing the HPV vaccine mandate in RI and advocating for informed consent.

 


What to expect when coming to Avon Cinema

For those unfamiliar with the East Side of Providence and Thayer Street in particular, where the Avon Cinema is located, here is some helpful advice.

Arriving to the show at the last minute, especially for evening shows, will make parking directly on Thayer St. very difficult, if not impossible.

You will also have to contend with parking meters.

Although, there are plenty of neighboring streets that should serve your purpose, so be prepared to walk a couple of blocks.

There are many great places to eat and little shops to visit on Thayer St., so you may want to arrive early and stop at a restaurant before the show to secure the best parking spot closest to the theater.

I highly recommend “Flatbread Pizza”, as they employ great people, the food is entirely organic, delicious, and is also very spacious establishment which is great for for groups.
Their Info:  161 Cushing St, Providence, RI 02906
Phone:(401) 273-2737

Here are some other options to consider for dining out:

There are several more pages after the first one, so be sure to scroll through the rest:
http://www.yelp.com/search?find_desc=Restaurants+On+Thayer+Street&find_loc=Providence,+RI&start=0&l=p:RI:Providence::College_Hill

Lastly, We are here for you!

Just contact us through the VAXXED/Rhode Island Event Page and we will help answer your questions! https://www.facebook.com/BringVAXXEDtoRI/events

Can’t wait to see you!


Rhode Islanders against mandated HPV vaccinations does not endorse or personally know the below lawyers, but they handle vaccine injury and is a step to look at and determine for yourself if they are right for you; if you had the unfortunate experience with a vaccine injury.

Transverse Myelitis Survivor? There’s money available to help if your Transverse Myelitis was triggered by vaccines like the flu shot, tetanus, and HPV shot. Our firm helps people file claims in the Federal Vaccine Court. Find out if you are eligible. https://www.mctlawyers.com/vaccine-injury/

 

~~~~~~~ Thank you so much for reading the whole message~~~~~~

Sincerely,

Rhode Islanders against mandated HPV vaccinations