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Gardasil (Human Papillomavirus Vaccine) - Summary

 
 



GARDASIL SUMMARY

GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18.

GARDASIL is indicated for the following:

Girls and Women

GARDASIL®1 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

  • Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18
  • Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

  • Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)
  • Cervical intraepithelial neoplasia (CIN) grade 1
  • Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
  • Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
Boys and Men

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Limitations of GARDASIL Use and Effectiveness

The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care. [See Patient Counseling Information.]

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. [See Clinical Studies (14.3, 14.4).]

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, and vaginal cancers; CIN; VIN; or VaIN.

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies.]

Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV 16 and 18.

GARDASIL does not protect against genital diseases not caused by HPV.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.


See all Gardasil indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Gardasil (Human Papillomavirus Vaccine)

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

One dose or 2? Cholera vaccination strategies
Source: Immune System / Vaccines News From Medical News Today [2015.08.26]
A new modeling study appearing this week in PLOS Medicine supports consideration of vaccination campaigns using a single dose of cholera vaccine versus campaigns using the recommended two doses given...

Study backs flu vaccinations for elderly
Source: Flu / Cold / SARS News From Medical News Today [2015.08.25]
A new study of the records of millions of nursing home residents affirms the value of influenza vaccination among the elderly.

Reducing pain during vaccination: New guideline to help manage pain in children and adults
Source: Immune System / Vaccines News From Medical News Today [2015.08.25]
A new Canadian guideline aims to ensure that pain during vaccination is minimized in both children and adults.

Project Boosts Vaccination Rates in At-Risk Pediatric Patients
Source: Medscape Infectious Diseases Headlines [2015.08.24]
A quality improvement project directed primarily at providers significantly improved PCV13 and PPSV23 vaccination rates in high-risk pediatric rheumatology patients.
Medscape Medical News

more news >>

Published Studies Related to Gardasil (Human Papillomavirus Vaccine)

Impact of malaria and helminth infections on immunogenicity of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Tanzania. [2014]
infections on the immunogenicity of the bivalent HPV-16/18 vaccine... CONCLUSIONS: The data show high HPV immunogenicity regardless of the presence of

A randomized, observer-blinded immunogenicity trial of Cervarix(®) and Gardasil(®) Human Papillomavirus vaccines in 12-15 year old girls. [2013]
CONCLUSIONS: These data demonstrate for the first time that cross-neutralizing

Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. [2013]
A randomized double-blind placebo-controlled phase II trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types most frequently associated with cervical cancer (types 16/18) and genital warts (types 6/11) in Japanese women aged 18-26 years...

Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women. [2013]
have an important public health impact... CONCLUSIONS: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had

Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. [2012]
The exploratory immunogenicity objective of this analysis was to characterize the titer of vaccine human papillomavirus (HPV)-type immunoglobulins in both peripartum maternal blood and the cord blood of infants born to women who received blinded therapy.

more studies >>

Clinical Trials Related to Gardasil (Human Papillomavirus Vaccine)

Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting [Completed]
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months. Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C): H0: δ ≤ −δ0 versus H1: δ > −δ0 where δ = log (GMTT )− log (GMTC) and δ0 is the pre-specified non-inferiority margin

Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine. [Completed]
Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations. This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule

Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil�)in HIV-infected Adolescents and Young Adults [Recruiting]
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.

A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men [Completed]
The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV) vaccine acceptability among college men based on the Health Belief Model through focus groups, (2) triangulate focus group results with a prior quantitative study in developing an intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3) test the efficacy of the above intervention based on the Health Belief Model by comparing it to a knowledge-based intervention. Approximately five focus groups with ten participants in each group with college students in the ages 18-25 years will be conducted at a large Midwestern University for the qualitative piece. Data will be analyzed for categories and triangulated with previous study to develop a theory based intervention. For the quantitative piece a randomized controlled design with 45 participants in each arm (theory based intervention and knowledge based intervention) will be implemented.

Electronic Messaging to Increase Human Papillomavirus Vaccine Utilization and Adherence Among College Students [Completed]
Introduction: Although vaccination against HPV and subsequent HPV-related cancers is a significant breakthrough, uptake is low. We sought to understand whether a low-cost intervention of electronic (text and/or email) appointment reminders coupled with electronic health educational messaging about HPV and the HPV vaccine could increase HPV vaccine uptake and knowledge among college students. Methods: Study participants included both female and male English speaking students between the ages of 18-26 who attended a large university in North Carolina. Students were randomized to the intervention or control group. Intervention group participants received the electronic messaging while the control group received standard of care at the student health center across a 7-month study period. Baseline and follow-up survey data was collected. Main outcome measures were completion of HPV-2 and HPV-3 and HPV and HPV vaccine knowledge. Study recruitment ran from August 2011 to December 2013. Results: Completion rates for the intervention and control group were similar for HPV-2 (53% vs. 52%) and HPV-3 (34% vs. 32%), respectively. The mean knowledge score at follow-up for intervention group participants (n=44, mean knowledge score = 93%, SD = 0. 08) was significantly higher (p=0. 01) than the mean knowledge score at baseline (n=44, mean knowledge score = 87%, SD = 0. 11). No significant changes in knowledge from baseline to follow-up were found for control group participants. The single most important predictor of HPV vaccine uptake overall was female gender where female participants were 2. 35 times [confidence interval (CI) 1. 17-4. 69] as likely to complete the series as compared to male participants. Conclusion: In this sample of college students, the electronic messaging intervention increased knowledge but not uptake. More randomized controlled trials on the efficacy of HPV vaccine electronic reminder interventions for catch-up age populations for both females and males are needed.

more trials >>

Reports of Suspected Gardasil (Human Papillomavirus Vaccine) Side Effects

Upper Respiratory Tract Infection (5)Abdominal Pain (4)Fatigue (4)Neuroleptic Malignant Syndrome (3)Activities of Daily Living Impaired (3)Encephalitis Autoimmune (3)Confusional State (2)Pancreatitis Acute (2)Increased Appetite (2)Basilar Migraine (2)more >>


Page last updated: 2015-08-28

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