Anal Cancer Clinical Trial
Official title:
A Randomized, Double-blinded, Multicenter and Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Recombinant Vaccine (Hansenula Polymorpha) in Chinese Males Aged 18-45 Years
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men.
The primary aim of this clinical trial is to evaluate the efficacy of the 9-valent HPV vaccine in men aged 18-45 years old. It will also learn about the safety and immunogenicity of the 9-valent HPV vaccine. Participants will inoculate the 9-valent HPV vaccine or a placebo according to the 0, 2, 6 month immunization program. Visit the clinic on the 8th and 31st day after each dose of vaccination for the collection of safety information, keeping a diary of their symptoms and medications. ;
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