A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Human, Papillomavirus Infections
About this trial
This is an interventional prevention trial for Human
Eligibility Criteria
Inclusion Criteria: Healthy adolescents and preadolescents with no prior sexual history Exclusion Criteria: Subjects with compromised immune system or have a history of severe allergic reaction
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
qHPV Vaccine in Base Study
Placebo in Base Study
qHPV Vaccine in Extension Study
Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
Represents participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.