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

This study has been completed.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00337428

Purpose

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.

Condition	Intervention	Phase
Neoplasms, Glandular and Epithelial Diphtheria Tetanus Whooping Cough Poliomyelitis	Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment 7 Months	Phase III

MedlinePlus related topics: Cancer Cough Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

Drug Information available for: Poliovirus Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX(TM) in Healthy Adolescents 11-17 Years of Age

Further study details as provided by Merck:

Primary Outcome Measures:

Comparable (non-inferior) immunogenicity for all vaccine components

Secondary Outcome Measures:

Acceptable safety profile

Enrollment:	800
Study Start Date:	May 2006
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337428

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_093, V501-024
Study First Received:	June 14, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00337428
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Healthy
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Motor Neuron Disease
Picornaviridae Infections

Cough
Central Nervous System Diseases
Diphtheria
Degenerative motor system disease
Motor neuron disease
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Myelitis
Enterovirus Infections
Clostridium Infections
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Bordetella Infections
RNA Virus Infections
Neoplasms
Neoplasms by Histologic Type
Corynebacterium Infections

Nervous System Diseases
Central Nervous System Viral Diseases
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009