A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007) - Trial NCT01073293
Access comprehensive clinical trial information for NCT01073293 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 1054 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 3
Apr 22, 2010
Jun 16, 2011
Primary Outcome
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503,Percentage of Participants With a V503 Injection-site Adverse Experience,Percentage of Participants With a Repevax™ Injection-site Adverse Experience,Percentage of Participants With Maximum Temperature =37.8 °C (=100.0 °F) (Oral or Oral Equivalent),Percentage of Participants With a Systemic Adverse Experience,Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody,Geometric Mean Titers of Pertussis Antibody Responses,Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody
Summary
This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is
 well tolerated and causes a non-inferior immune response when compared to administration of
 REPEVAX™ one month following the first dose of V503.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT01073293
Non-Device Trial