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ACTIVE NOT RECRUITING
NCT04537156
PHASE3

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

Sponsor: Xiamen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

9327

Start Date

2020-09-05

Completion Date

2027-12-31

Last Updated

2025-11-21

Healthy Volunteers

Yes

Interventions

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.

Locations (2)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Sichuan Provincial Centre for Disease Control and Prevention

Chengdu, Sichuan, China