NCT04425291

Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) and 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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,680 (actual)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

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	4-valent HPV Vaccine	Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.
BIOLOGICAL	9-valent HPV Vaccine	Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
BIOLOGICAL	GARDASIL®	Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.

Timeline

• Start date: 2020-05-28
• Primary completion: 2021-09-06
• Completion: 2021-09-06
• First posted: 2020-06-11
• Last updated: 2022-02-25

Locations

1 site across 1 country: China