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

This study has been completed.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00325130

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 (Tdap) vaccine and a meningococcal conjugate 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 Meningitis	Biological: HPV rL1 6 11 16 18 VLP vaccine (yeast)	Phase III

MedlinePlus related topics: Cancer Cough Diphtheria Meningitis Tetanus Whooping Cough

Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine Meningococcal Vaccines Meningococcal Conjugate Vaccine

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 Menactra(TM) and ADACEL(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:	1040
Study Start Date:	April 2006
Study Completion Date:	May 2008

Intervention Details:

Duration of Treatment: 7 months

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 and pertussis

Exclusion Criteria:

Must not have received a vaccine against diphtheria, tetanus and pertussis in the past 5 years
Must not have received any prior human papillomavirus (HPV) vaccine or meningococcal vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325130

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_092, V501-025
Study First Received:	May 11, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00325130
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Whooping Cough
Cough
Central Nervous System Diseases
Healthy
Diphtheria
Tetanus
Whooping cough

Meningitis
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Central Nervous System Infections
Respiratory Tract Infections
Clostridium Infections
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Bordetella Infections
Neoplasms
Neoplasms by Histologic Type
Corynebacterium Infections

Nervous System Diseases
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009