NCT01254643

A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

Name: Clinical Trial NCT01254643
Creator: Merck Sharp & Dohme LLC
Keywords: Papillomavirus Infections, V503, Phase 3, biological, clinical trial

A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls

Merck Sharp & Dohme LLC·Phase 3·ClinicalTrials.gov·biologicalCompleted

View on ClinicalTrials.gov →

Study focus

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

Sponsor & location

Primary sponsor: Merck Sharp & Dohme LLC

Timeline & enrollment

Phase: Phase 3
Start date: Jan 12, 2011
End date: Aug 10, 2013
Enrollment: 100 participants

Primary outcome

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine,Percentage of Participants With an Injection-site Adverse Event (AE),Percentage of Participants With a Non-Injection Site (Systemic) AE,Percentage of Participants With a Vaccine-related AE

Summary

This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

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: NCT01254643
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT01254643 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Completed. The study focuses on Papillomavirus Infections. Target enrollment is 100 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.