Papilloma Viral Infection Clinical Trial
Official title:
A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men
Primary objective
To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs)
for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men
Secondary objectives
- To evaluate the tolerability of V503 in 16- to 26-year-old men.
- To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52,
58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who
received V503 or GARDASIL
;
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