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NCT01073293

A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)
Merck Sharp & Dohme LLC·Phase 3·ClinicalTrials.gov·biologicalCompleted
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Study focus
Disease/Condition
Papillomavirus Infections
Drug/Device/Intervention
V503 Vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Timeline & enrollment
Phase
Phase 3
Start date
Apr 22, 2010
End date
Jun 16, 2011
Enrollment
1054 participants
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
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
NCT01073293
Type
Non-Device Trial
About this record

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.

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.