NCT03998254

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

Name: Clinical Trial NCT03998254
Creator: Merck Sharp & Dohme Corp.
Keywords: Papillomavirus Infections, V503, Phase 3, drug, clinical trial, China

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

Merck Sharp & Dohme Corp.·Phase 3·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Papillomavirus Infections
Drug/Device/Intervention: V503
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Merck Sharp & Dohme Corp.
Location: Guilin,Guilin,Changzhi,Yuncheng,Mianyang,Mianyang, China

Timeline & enrollment

Phase: Phase 3
Start date: Jun 26, 2019
End date: Mar 31, 2028
Enrollment: 6000 participants

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

Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT03998254
Type: Non-Device Trial

About this record

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.