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ACTIVE NOT RECRUITING
NCT03998254
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

6000

Start Date

2019-06-26

Completion Date

2028-03-31

Last Updated

2022-11-16

Healthy Volunteers

Yes

Interventions

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

Locations (6)

Lingchuan Center for Disease Control and Prevention ( Site 0002)

Guilin, Guangxi, China

Quanzhou Center for Disease Control and Prevention ( Site 0001)

Guilin, Guangxi, China

Xiangyuan Center for Disease Control and Prevention ( Site 0003)

Changzhi, Shanxi, China

Yanhu Center for Disease Control and Prevention of Yuncheng ( Site 0004)

Yuncheng, Shanxi, China

Mianyang Center for Disease Control and Prevention ( Site 0005)

Mianyang, Sichuan, China

Santai County Center for Disease Control and Prevention ( Site 0006)

Mianyang, Sichuan, China