NCT03998254

Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)

A Phase 3 Randomized, Double-Blinded, Controlled With GARDASIL® Efficacy, Immunogenicity and Safety Study of V503 [a 9-Valent HPV Vaccine] in Chinese Women 20 to 45 Years of Age

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy, immunogenicity and safety of 9-valent human papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month persistent infection at least 1 month post Dose 3, compared with quadrivalent HPV (qHPV) vaccine in women 20 to 45 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type; and 9vHPV vaccine induces non-inferior competitive luminex immunoassay (cLIA) geometric mean titers (GMTs) for each of HPV 6, 11, 16, and 18 one month post Dose 3, compared with qHPV vaccine in women 20 to 45 years of age who are seronegative at Day 1 and PCR negative Day 1 through Month 7 to the relevant HPV type.

Detailed description

This study has two stages with the Stage I expected from Day 1 through Month 30, and the Stage II expected post-Month 30 to Month 90. The Stage I study is a case-driven study which aims to accrue at least 20 cases of HPV 31/33/45/52/58-related 12-month persistent infection and at least 39 cases of HPV 31/33/45/52/58-related 6-month persistent infection by completion of Month 30 visit. The Stage II study is a case-driven study which aims to accrue at least 12 cases of HPV 31/33/45/52/58-related cervical intraepithelial neoplasia grade 2 or 3 (CIN 2/3), cervical adenocarcinoma in situ (AIS), and cervical cancer observed in both Stage I and Stage II, by completion of Month 90 visit.

Conditions

• Papillomavirus Infections

Interventions

Type	Name	Description
DRUG	V503	9vHPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine
DRUG	Gardasil	qHPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine

Timeline

• Start date: 2019-06-26
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2019-06-26
• Last updated: 2022-11-16

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study