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)

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

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