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Gardasil (Human Papillomavirus Vaccine) - 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 >>


Media Articles Related to Gardasil (Human Papillomavirus Vaccine)

Physicians Blamed for Low HPV Vaccination Rates
Source: Medscape Pediatrics Headlines [2015.07.30]
Insufficient recommendations by clinicians is the 'primary roadblock' to improving vaccination against HPV, the director of the CDC's National Center for Immunization and Respiratory Diseases said.
Medscape Medical News

Vaccination rates in older adults fall short of targets
Source: Flu / Cold / SARS News From Medical News Today [2015.07.30]
New white paper from Alliance for Aging Research offers recommendations for improvementThe nonprofit Alliance for Aging Research released a white paper, Our Best Shot: Expanding Prevention...

Vaccination Schedule for Adults and Adolescents
Source: MedicineNet Chickenpox (Varicella) Specialty [2015.07.07]
Title: Vaccination Schedule for Adults and Adolescents
Category: Procedures and Tests
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/7/2015 12:00:00 AM

HPV Vaccination Tied to Drop in Precancerous Cervical Lesions in U.S.
Source: MedicineNet Cervical Cancer Specialty [2015.06.22]
Title: HPV Vaccination Tied to Drop in Precancerous Cervical Lesions in U.S.
Category: Health News
Created: 6/22/2015 12:00:00 AM
Last Editorial Review: 6/22/2015 12:00:00 AM

Widespread Vaccination Fights Serious Stomach Infection in Kids: CDC
Source: MedicineNet Rotavirus Specialty [2015.06.10]
Title: Widespread Vaccination Fights Serious Stomach Infection in Kids: CDC
Category: Health News
Created: 6/9/2015 12:00:00 AM
Last Editorial Review: 6/10/2015 12:00:00 AM

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)

A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17 [Not yet recruiting]
This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.

Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women [Not yet recruiting]
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.

Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy [Recruiting]
Many IBD patients take immunosuppressive agents and we are uncertain as to their capacity to mount a truly protective response after vaccination. If IBD patients do not have an adequate immunological response, they may need to increase the dosage or get booster shots. Many clinicians who treat patients with autoimmune diseases are asking if the vaccine is safe and effective. Thus, this study has important clinical and public health significance because more than one million people in the United States who have been diagnosed with IBD.

There is not much studied about HPV and immunocompromised patients. Research on healthy women who were immunized with a set of three HPV vaccines demonstrated significantly increased antibody titers. In addition, they had significantly reduced HPV incident and persistent infection and HPV-related disease (cervical, vulvar, and vaginal cancers, cervical intraepithelial neoplasia, genital warts) through five years of follow-up compared to controls who received a placebo. The HPV vaccine was well tolerated without significant side effects.

The aims of this research are to measure the immune response in 9-26 year old IBD patients who are on immunosuppressive agents after receiving the HPV vaccine compared with controls. We will also evaluate the number and type of vaccine-associated adverse events as well as the disease activity and flare-ups that occur after each dose of vaccine. We hypothesize that IBD patients on immunosuppressive therapy will have an equivalent immune response to HPV types 6, 11, 16 and 18 at one month postdose 3 compared to healthy age-matched historical controls.

The patient population includes IBD patients who are on immunosuppressive medications. Recruiting approximately 100 patients will provide adequate power for the study. A blood sample will be taken from all IBD patients to evaluate baseline antibody levels and markers (e. g., ESR, CBC, albumin) before or immediately after immunization with the HPV vaccine. Lab tests will be redrawn at 7 months to evaluate the level of antibody titers and follow the markers. During the study, we will track basic laboratory measures, disease status by using the Pediatric Crohn's Disease Active Index or Harvey-Bradshaw Index for UC, side effects from the vaccinations, and other adverse events.

Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females [Recruiting]
African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. To address this need, the proposed study is an exciting opportunity to build upon a relationship previously formed between Planned Parenthood of Georgia and Emory University Rollins School of Public Health. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD.

We propose to recruit 400 unmarried African American adolescent females, 13-18 years of age, from Planned Parenthood in Atlanta, Georgia. At Planned Parenthood, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at Planned Parenthood as part of their routine standard of care.

With the help of clinic staff, participant medical records will be reviewed over a 6 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil® Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females [Recruiting]

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: 2015-07-30

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