Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

Summary

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

Timeline

Start

2021-03-15

Primary completion

2029-10-23

Completion

2029-10-23

Publications

• Results Teppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12.
• Results Klein NP, Wiesner A, Bautista O, Group T, Kanu K, Li ZL, McCauley J, Saxena K, Tota J, Luxembourg A, Bonawitz R. Immunogenicity and Safety of Extended-Interval 2-Dose Regimens of 9vHPV Vaccine. Pediatrics. 2024 Aug 1;154(2):e2023064693. doi: 10.1542/peds.2023-064693.

Drugs

Indications