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A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)

NCT07785843 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 930

Last updated 2026-08-25

No results posted yet for this study

Summary

Researchers want to learn if V503 (also called the 9-valent human papillomavirus \[9vHPV\] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine.

The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18).

The goals of the trial are to learn:

* If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine
* About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients

Conditions

  • Papillomavirus Infections

Interventions

BIOLOGICAL

V503

V503 (9-vHPV vaccine \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\]) administered as a 0.5-mL intramuscular (IM) injection on Day 1, Month 2, and Month 6

BIOLOGICAL

Placebo

Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-23
Primary Completion
2027-12-18
Completion
2028-12-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785843 on ClinicalTrials.gov