NCT04782895

Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Conditions

• Cervical Cancer
• Condylomata Acuminata

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)	Three doses administered intramuscularly at 0, 45 day and 6 month.
BIOLOGICAL	Gardasil®9	Three doses administered intramuscularly at 0, 45 day and 6 month.

Timeline

• Start date: 2021-03-14
• Primary completion: 2022-05-30
• Completion: 2022-07-25
• First posted: 2021-03-04
• Last updated: 2023-06-15

Locations

1 site across 1 country: China