NCT06866574

A Phase III Trial 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) in Chinese Males

A Multicenter, Randomized, Double-Blind, Aluminum Adjuvant-Controlled Phase III Clinical Trial 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) in Chinese Males Aged 18 to 45 Years

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,300 (estimated)
• Sponsor: Xiamen University · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Penile/Perineal /Perianal Intraepithelial Neoplasia
• Anal Intraepithelial Neoplasia
• Penile/Perianal/Perineal Cancer
• Anal Cancer
• Genital Warts

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)	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)
BIOLOGICAL	Aluminum Adjuvant	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).

Timeline

• Start date: 2025-04-11
• Primary completion: 2031-09-30
• Completion: 2031-09-30
• First posted: 2025-03-10
• Last updated: 2025-07-31

Locations

4 sites across 1 country: China