NCT01984697

A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,518 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 9 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This was a 37-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 was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 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 received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)	V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Timeline

• Start date: 2013-12-12
• Primary completion: 2015-06-19
• Completion: 2017-07-24
• First posted: 2013-11-15
• Last updated: 2018-08-08
• Results posted: 2016-04-26