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ACTIVE NOT RECRUITING
NCT05056402
PHASE3

An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old

Sponsor: Xiamen University

View on ClinicalTrials.gov

Summary

This is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.

Official title: Immunogenicity Non-inferiority Immuno-bridging Study of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine (E.Coli) in Healthy Population Aged 9-17 Years Old vs Aged 18-26 Years Old

Key Details

Gender

All

Age Range

9 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

1382

Start Date

2021-09-19

Completion Date

2025-12-31

Last Updated

2025-07-22

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Three doses administered intramuscularly at 0, 1 and 6 month.

BIOLOGICAL

2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Two doses administered intramuscularly at 0 and 6 month.

Locations (1)

Sichuan Provincial Centre for Disease Control and Prevention

Chengdu, Sichuan, China