Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023) - Trial NCT03998254
Access comprehensive clinical trial information for NCT03998254 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme Corp. and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 6000 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Merck Sharp & Dohme Corp.
Timeline & Enrollment
Phase 3
Jun 26, 2019
Mar 31, 2028
Primary Outcome
Stage I: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related 12-month Persistent Infection,Stage I: Geometric Mean Titers to HPV Types 6, 11, 16, and 18 Antibodies,Stage I: Percentage of Participants Who Report at Least 1 Solicited Injection-site Adverse Event,Stage I: Percentage of Participants Who Report at Least 1 Solicited Systemic Adverse Event,Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE),Stage II: Combined Incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 2/3, AIS, and cervical cancer,Stages I/II: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03998254
Non-Device Trial