Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 14, 2006

Last Updated Date

February 5, 2009

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

Comparable (non-inferior) immunogenicity for all vaccine components [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00337428 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Acceptable safety profile [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Neoplasms, Glandular and Epithelial
Diphtheria
Tetanus
Whooping Cough
Poliomyelitis

Intervention ^†

Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
Biological: Comparator: REPEVAX™ (Concomitant)
Biological: Comparator: REPEVAX™ (Non-Concomitant)

Study Arms / Comparison Groups

Experimental: Concomitant/CMF
Experimental: Non-Concomitant/CMF
Experimental: Concomitant/FMF
Experimental: Non-Concomitant/FMF

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 ^†

Completed

Enrollment ^†

843

Completion Date

February 2008

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

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

Both

Ages

11 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00337428

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

V501-024

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.