Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024)

Summary

This study investigates the immunogenicity and safety of the 9vHPV vaccine in healthy Chinese females 9 to 45 years of age. The study consists of Stage I (Day 1 to Month 7) and Stage II (post Month 7 to Month 60). Stage II will report the long-term immunogenicity and safety in the 9-19 year-old age group only. The dual-primary hypotheses of Stage I are that 9vHPV vaccine induces non-inferior immune responses in females 9 to 19 years of age who are seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 1 month post Dose 3, and 9vHPV vaccine induces non-inferior immune responses in females 27 to 45 years of age who are seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to the relevant HPV type, as measured by the seroconversion percentages to each of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 1 month post Dose 3. (Each vaccine component will be analyzed separately.)

Timeline

Start

2019-04-27

Primary completion

2025-02-28

Completion

2025-02-28

Publications

• Lv H, Wang S, Liang Z, Yu W, Yan C, Chen Y, Hu X, Fu R, Zheng M, Group T, Luxembourg A, Liao X, Chen Z. Immunogenicity and safety of the 9-valent human papillomavirus vaccine in Chinese females 9-45 years of age: A phase 3 open-label study. Vaccine. 2022 May 20;40(23):3263-3271. doi: 10.1016/j.vaccine.2022.02.061. Epub 2022 Apr 26.

Drugs

Indications