Recombinant 9-valent Human Papillomavirus vaccine (Shanghai Bovax Biotechnology)

Primary objective: To evaluate the safety and tolerability of the HPV 9-valent vaccine in healthy Chinese males aged 9-45 years. Secondary objective: To evaluate the immunogenicity of the HPV 9-valent vaccine in healthy Chinese males aged 9-45 years.

Primary objective: To prove that the HPV 9-valent vaccine is non-inferior to Chinese women aged 20-45 in terms of neutralization antibody positive conversion rate against HPV6, 11, 16, 18, 31, 33, 45, 52, and 58 30 days after the full course of immunization in Chinese women aged 9-19 years, and the neutralization antibody negative pre-immunization group has a positive conversion rate against HPV6, 11, 16, 18, 31, 33, 45, 52, and 58. Secondary objective: (1) Immunogenicity: ① To prove that the HPV 9-valent vaccine is non-inferior to Chinese women aged 20-45 in terms of neutralization antibody positive conversion rate against HPV6, 11, 16, 18, 31, 33, 45, 52, and 58 30 days after the full course of immunization in Chinese women aged 9-19 years, and the neutralization antibody negative pre-immunization group has a ...20-45 years. ② To prove that the HPV 9-valent vaccine is administered to Chinese females aged 9-19 years old 30 days after the full course of vaccination, the neutralization antibody positive conversion rate against HPV6, 11, 16, 18, 31, 33, 45, 52, and 58 in the population with negative neutralization antibodies before vaccination is non-inferior to that of Chinese females aged 20-26 years old. ③ To prove that the HPV 9-valent vaccine is administered to Chinese females aged 9-19 years old 30 days after the full course of vaccination, the GMT against HPV6, 11, 16, 18, 31, 33, 45, 52, and 58 in the population with negative neutralization antibodies before vaccination is non-inferior to that of Chinese females aged 20-26 years old. ④ To evaluate the immunity persistence of the HPV 9-valent vaccine in females aged 9-19 years old 12, 14, 36, 48, and 60 months after the first dose. (2) Safety: To evaluate the safety of the HPV 9-valent vaccine in Chinese females aged 9-45 years old.