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NCT05450705

V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

Active, enrolled Phase 3 Last updated 2 September 2022
What this trial tests

Phase 3 trial testing 9vHPV vaccine in Papillomavirus Infections in 1,500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
22 July 2022
Primary endpoint
3 August 2029
3 August 2029

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,500
Start date22 July 2022
Primary completion3 August 2029
Estimated completion3 August 2029
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 9 to 26, female only, with Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of 9vHPV vaccine

Trials testing the same drug.

Other recruiting trials for Papillomavirus Infections

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05450705.

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