Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)

Primary objective:

• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

Secondary objectives:

• To evaluate the tolerability of V503 in 9-15 year-old girls.
• To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.

Inclusion Criteria:

• Female from 9 to 15 years old.
• Good physical health.

Exclusion Criteria:

• Known allergy to any vaccine component.
• History of severe allergic reaction.
• Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Pregnant subject.
• Immunocompromised or immunodeficient subject.
• Splenectomy.
• Receipt of medication / vaccine that may interfere with study assessment.
• Fever
• History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
• Any condition that might interfere with study assessment.