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.
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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)
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: Î´ â‰¤ âˆ’Î´0 versus H1: Î´ > âˆ’Î´0 where Î´ = log (GMTT )âˆ’ log (GMTC) and Î´0 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 (Gardasilï¿½)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
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
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.
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 >>
Page last updated: 2016-11-23