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). - Trial NCT01254643
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.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
Jan 12, 2011
Aug 10, 2013
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
Data Source
ClinicalTrials.gov
NCT01254643
Non-Device Trial