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The primary vaccination series consists of 3 separate 0.5-mL doses administered according to the following schedule: 0, 2, 6 months.
If an alternate vaccination schedule is necessary, the 2nd dose should be administered at least 1 month after the 1st dose and the 3rd dose should be administered at least 3 months after the 2nd dose. All 3 doses should be given within a 1-year period.
The need for a booster dose has not been established.
Children: Gardasil is not recommended for use in children <9 years due to insufficient data on immunogenicity, safety and efficacy (see Pharmacology under Actions).
Administration: Gardasil should be administered by IM injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Gardasil must not be injected intravascularly. SC and intradermal administration have not been studied, and therefore, are not recommended (see Cautions for Usage for disposal and other handling).
