NCT05056402

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,382 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: All
• Age: 9 Years – 26 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Cancer
• Condylomata Acuminata

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-19
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-09-24
• Last updated: 2025-07-22

Locations

1 site across 1 country: China