NCT04895020

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 9 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

Detailed description

This study (protocol 9-HPV-3003) is an immunogenicity and safety study in the subjects (9-19 years of age) who received the 9-valent HPV recombinant vaccine compared with the subjects (20-45 years of age). In this study, we will assess whether the immunogenicity of the 9-valent HPV vaccine given 3-dose schedule in the subjects (9-19 years of age) in noninferior to that in the subjects (20-45 years of age) receiving 3 doses, while assessing the safety of this vaccine.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	9-valent HPV vaccine	9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

Timeline

• Start date: 2021-05-28
• Primary completion: 2023-01-13
• Completion: 2026-05-01
• First posted: 2021-05-20
• Last updated: 2024-04-17

Locations

1 site across 1 country: China