Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

Summary

This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period. In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).

Timeline

Start

2018-08-22

Primary completion

2020-02-28

Completion

2020-02-28

Publications

• Background Zhao F, Jastorff A, Hong Y, Hu S, Chen W, Xu X, Zhu Y, Zhu J, Zhang X, Zhang W, Xu D, Wang D, Tang R, Sun Y, Shen Y, Pan Q, Yin J, Liu D, Liu B, Karkada N, Jiang C, Cui J, Chen F, Bi J, Bao Y, Zhou X, Cartier C, Hu Y, Borys D. Safety of AS04-HPV-16/18 vaccine in Chinese women aged 26 years and older and long-term protective effect in women vaccinated at age 18-25 years: A 10-year follow-up study. Asia Pac J Clin Oncol. 2023 Aug;19(4):458-467. doi: 10.1111/ajco.13833. Epub 2022 Sep 13.

Drugs

Indications