NCT04537156

Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

A Multicenter, Randomized, Double-Blind, Controlled (Bivalent Human Papillomavirus Vaccine (16,18 Type)(E. Coli)) Phase III Clinical Trial to Estimate Efficacy, Immunogenicity and Safty of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Women Aged 18 to 45 Years

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,327 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Cancer
• Condylomata Acuminata

Interventions

Type	Name	Description
BIOLOGICAL	Nonavalent HPV vaccine	Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
BIOLOGICAL	Bivalent HPV vaccine	Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Timeline

• Start date: 2020-09-05
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-09-03
• Last updated: 2025-11-21

Locations

2 sites across 1 country: China