NCT04422366

Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,000 (estimated)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .

Conditions

• Cervical Cancer
• Vulvar Cancer
• Vaginal Cancer
• CIN1
• CIN2
• CIN3
• VaIN1
• VaIN2
• VaIN3
• Genital Wart
• VIN 1
• VIN 2
• VIN 3
• AIS

Interventions

Type	Name	Description
BIOLOGICAL	9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)	Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
BIOLOGICAL	GARDASIL®	Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule

Timeline

• Start date: 2020-04-28
• Primary completion: 2027-09-15
• Completion: 2029-09-15
• First posted: 2020-06-09
• Last updated: 2024-06-07

Locations

1 site across 1 country: China