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)
Morning Break: Couric on Gardasil, Pot in Fla.
Source: MedPageToday.com - medical news plus CME for physicians [2013.12.06]
(MedPage Today) -- Health news and commentary from around the Web, gathered by the MedPage Today staff.
Influenza Vaccination Rates Up; Goal Not Met in Asthmatics
Source: Medscape Medical News Headlines [2013.12.06]
From 2010 to 2011, 50% of people with asthma received the influenza vaccine, which is an increase from 36% just 5 years earlier but still below the goal of 80% in children and 90% in adults.
Medscape Medical News
Chickenpox vaccination not linked to increased shingles incidence
Source: Immune System / Vaccines News From Medical News Today [2013.12.03]
A new study claims to have ruled out a link between childhood vaccination against varicella (chickenpox) and the increased incidence of herpes zoster (shingles) in adults, according to an article published in the Annals of Internal Medicine.Chickenpox and shingles are both caused by the same virus - the varicella zoster virus (VZV).
FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination
Source: Immune System / Vaccines News From Medical News Today [2013.11.29]
A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S.
Vaccinations: One more weapon in the fight against antibiotic resistance
Source: Immune System / Vaccines News From Medical News Today [2013.11.26]
Doctors, pharmacists and nurses are being asked to encourage their patients to keep up with the vaccinations recommended in the National Immunisation Program (NIP) schedule, as immunisation can help reduce the rates of vaccine-preventable diseases that may have required antibiotics to treat them or their complications.
Published Studies Related to Gardasil (Human Papillomavirus Vaccine)
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.
Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine. [2011.03.15]
The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine... As most AIS lesions were HPV16/18-related, prophylactic HPV vaccination should reduce the incidence of invasive adenocarcinoma.
The accuracy of colposcopic biopsy: analyses from the placebo arm of the Gardasil clinical trials. [2011.03.15]
We evaluated the overall agreement between colposcopically directed biopsies and the definitive excisional specimens within the context of three clinical trials. A total of 737 women aged 16-45 who had a cervical biopsy taken within 6 months before their definitive therapy were included...
Human papillomavirus 16 (HPV 16) and HPV 18 antibody responses measured by pseudovirus neutralization and competitive Luminex assays in a two- versus three-dose HPV vaccine trial. [2011.03]
Human papillomavirus 16 (HPV 16) and HPV 18 antibody responses in a 2- versus 3-dose HPV vaccine (Gardasil) trial were measured by a pseudovirus neutralizing antibody (PsV NAb) assay and by the Merck competitive Luminex immunoassay (cLIA). Eight hundred twenty-four female subjects assigned to three dosing regimens (group 1, 9 to 13 years old; 2 doses, months 0 and 6 [n = 259]; group 2, 9 to 13 years old; 3 doses, months 0, 2, and 6 [n = 260]; group 3, 16 to 26 years old; 3 doses, months 0, 2, and 6 [n = 305]) had postvaccine responses assessed 1 month after the last dose.
Quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18 vaccine: for the
prevention of genital warts in males. 
The quadrivalent HPV types 6, 11, 16, 18 vaccine (Gardasil┬«) is a recombinant
vaccine comprising purified virus-like particles derived from the L1 capsid
proteins of HPV types 6, 11, 16 and 18. The vaccine was highly immunogenic... The most common adverse events reported were injection-site
related, and most of these were of mild to moderate severity.
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.
Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients [Not yet recruiting]
Cervical neoplasia is increased in women with SLE most likely due to cervical infection with
human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.
Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients
(who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can
prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies
have been done on the use of this vaccine in SLE. The investigators hypothesize that
Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in
patients with mild to moderate and minimally active or inactive SLE and measure how well
they make protective antibodies after receiving the vaccine. In other words this will check
how well the vaccine works in SLE.
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.
A Phase I Trial of Safety and Immunogenicity of Gardasil(Registered Trademark) Vaccination Post Stem Cell Transplantation in Patients With and Without Immunosuppression [Recruiting]
- Gardasil(Registered Trademark), a recently approved vaccine for the sexually
transmitted human papillomavirus (HPV), provides immunity to four types of HPV that are
associated with genital warts and cervical, vaginal, and vulvar precancer and cancer.
The vaccine has been shown to be highly effective in preventing infection with these
HPV types and was approved for use by the Food and Drug Administration.
- More research is needed about the vaccine's ability to induce immunity in individuals
with suppressed immune systems, such as those who have had other kinds of cancer
treatment such as stem cell transplant. Genital warts, precancer, and cancer have been
reported as a late complication after stem cell transplant. Researchers are interested
in determining whether the HPV vaccine is safe to give and able to induce immunity in
female stem cell transplant recipients, their female donors, and healthy female
- To assess the safety and immune response of the HPV vaccine in female recipients of stem
cell transplants who are either off or on stable doses of immunosuppression.
- Females between 18 and 45 years of age who have had allogenic stem cell transplants.
- Healthy female volunteers, including stem cell donors, are also eligible for this
- Participants will be screened with a physical examination, blood and urine tests, and
saliva samples, and will be asked to complete a sexual quality of life questionnaire.
- Sexually active participants will also have a routine gynecologic evaluation.
- Participants will receive three HPV vaccinations according to the standard vaccination
schedule (with the second and third following 2 and 6 months after the first).
Participants will record their daily temperature and any reactions to the vaccine on a
vaccine report card for 1 week after each vaccination.
- Participants will have clinic visits for further testing 2, 6, 7, and 12 months after
receiving the first HPV vaccine.
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.
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 >>