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:
Boys and Men
- 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
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.
Media Articles Related to Gardasil (Human Papillomavirus Vaccine)
Tdap Vaccination During Pregnancy Remains Low
Source: Medscape Public Health & Prevention Headlines [2015.05.22]
Just more than half of women reported Tdap vaccination before, during, or after pregnancy, which falls far short of current recommendations for vaccination during pregnancy.
Medscape Medical News
E-Reminders May Boost HPV Vaccination Rates
Source: MedicineNet Cervical Cancer Specialty [2015.05.20]
Title: E-Reminders May Boost HPV Vaccination Rates
Category: Health News
Created: 5/19/2015 12:00:00 AM
Last Editorial Review: 5/20/2015 12:00:00 AM
UCSF-led study explains how early childhood vaccination reduces leukemia risk
Source: Immune System / Vaccines News From Medical News Today [2015.05.19]
Chronic infections push 'pre-leukemia' cells, common in newborns, into malignancyA team led by UCSF researchers has discovered how a commonly administered vaccine protects against acute...
HPV vaccination may benefit boys as well as girls
Source: Sexual Health / STDs News From Medical News Today [2015.05.13]
A new study partly supports vaccinating all boys against HPV and adds evidence of wider cancer benefit for both sexes, if girls have a higher uptake of injections.
HPV Vaccination for Girls May Help Prevent Cancers in Males
Source: MedicineNet Cancer Prevention Specialty [2015.05.13]
Title: HPV Vaccination for Girls May Help Prevent Cancers in Males
Category: Health News
Created: 5/12/2015 12:00:00 AM
Last Editorial Review: 5/13/2015 12:00:00 AM
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. 
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(Â®) and
Gardasil(Â®) Human Papillomavirus vaccines in 12-15 year old girls. 
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 18-26Â years. 
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 18-26Â 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
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
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.
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
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
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]
Reports of Suspected Gardasil (Human Papillomavirus Vaccine) Side Effects
Upper Respiratory Tract Infection (5),
Abdominal Pain (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 >>