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

Cervical Cancer Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04895020
Study type Interventional
Source Shanghai Bovax Biotechnology Co., Ltd.
Contact Huakun Lv
Phone 13588458021
Email hklv@cdc.zj.cn
Status Recruiting
Phase Phase 3
Start date May 28, 2021
Completion date May 2026
View Details
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