Brief Title
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Official Title
An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX™ in Healthy Adolescents 11-17 Years of Age
Brief Summary
Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)
Condition
Neoplasms, Glandular and Epithelial
Intervention
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
Study Arms / Comparison Groups
Group 1
Description: Concomitant/CMF
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
843
Start Date
May 2006
Completion Date
May 2007
Primary Completion Date
May 2007
Eligibility Criteria
Inclusion Criteria: - Must be healthy boys or girls, 11-17 years of age - Must be a virgin with no intention of becoming sexually active during the study period - Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio Exclusion Criteria: - Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years - Must not have received any prior human papillomavirus (HPV) vaccine
Gender
All
Ages
11 Years - 17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Monitor, ,
Administrative Informations
NCT ID
NCT00337428
Organization ID
V501-024
Secondary IDs
2005_093
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme LLC
Study Sponsor
Medical Monitor, Study Director, Merck Sharp & Dohme LLC
Verification Date
September 2016