This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in Chinese males aged 18-45 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
9,300
Participants received 3 doses of 9-valent HPV vaccine according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle of the upper arm)
Participants received 3 doses of Aluminum Adjuvant according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle the upper arm).
Fujian Provincial Center for Disease Control and Prevention
Fuzhou, Fujian, China
Sichuan Provincial Center for Disease Control and Prevention
Chengdu, Sichuan, China
Yunnan Provincial Center for Disease Control and Prevention
Kunming, Yunnan, China
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, Penile/Perineal/Perianal Intraepithelial Neoplasia 1+ (PIN1+), and Penile/Perineal/Perianal cancer (pooled across all specified HPV types)
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated genital warts, PIN1+ and Penile/Perineal/Perianal cancer (pooled across all specified HPV types) in the Per-Protocol Set (PPS) population.
Time frame: 0-78 months
HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated Anal Intraepithelial Neoplasia 1+ (AIN1+) and Anal cancer (pooled across all specified HPV types), only in MSM participants
To evaluate the efficacy of the investigational vaccine in preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58-associated AIN1+ and Anal cancer in the PPS population of MSM participants.
Time frame: 0-78 months
HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types)
To evaluate the efficacy of the investigational vaccine in preventing HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58-related External Genital and Intra-anal 12-month Persistent Infection (pooled across all specified HPV types).
Time frame: 0-78 months
Seroconversion and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
To evaluate the immunogenicity of the investigational vaccine.
Time frame: 0-7 months
Seropositivity and antibody levels of neutralizing antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 18, 30, 42, 54, 66 and 78
To evaluate the long-term immunopersistence of the investigational vaccine.
Time frame: 18-78 months
Adverse events/reactions occurred within 30 days after each vaccination
To evaluate the safety of the investigational vaccine.
Time frame: Within 30 days (Day 0-30) after each vaccination
Serious adverse events occurred throughout the study
To evaluate the safety of the investigational vaccine.
Time frame: 0-78 months
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