A commitment to demonstrating lasting protection
In an extension phase
GARDASIL demonstrated efficacy through 5 years.3
GARDASIL will be studied
clinically through the year 2013.4
GARDASIL is a vaccine indicated in girls and women 9 to 26 years of age for the
prevention of cervical cancer, precancerous or dysplastic lesions, and genital
warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.
Select Safety Information
GARDASIL is contraindicated in individuals with hypersensitivity, including
severe allergic reactions to yeast, or after a previous dose of GARDASIL.
GARDASIL does not substitute for routine cervical cancer screening, and women
who receive GARDASIL should continue to undergo screening.
GARDASIL is not recommended for use in pregnant women.
GARDASIL has not been demonstrated to provide protection against diseases
from vaccine and non-vaccine HPV types to which a woman has
previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active genital warts;
cervical cancer; cervical intraepithelial neoplasia, vulvar intraepithelial
neoplasia, or vaginal intraepithelial neoplasia.
GARDASIL has not been shown to protect against diseases due to
HPV types not contained in the vaccine.
The most common adverse reaction was headache. Common adverse reactions that
were observed among recipients of GARDASIL at a frequency of at least 1.0%
and greater than placebo were fever, nausea, dizziness; and injection-site
pain, swelling, erythema, pruritus, and bruising.
In addition, syncope has been reported following vaccination with GARDASIL,
sometimes resulting in falling with injury. Observation for 15 minutes after
administration is recommended.
GARDASIL should be administered in 3 separate intramuscular injections in
the deltoid region of the upper arm or in the higher anterolateral area of
the thigh over a 6-month period with the first dose at an elected date, the
second dose 2 months after the first dose, and the third dose 6 months after
the first dose.
Before administering GARDASIL, please read the Prescribing
Information and Patient
Product Information.
aCI=Confidence Interval
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