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

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 is ongoing, but not recruiting participants.

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

ChemIDplus related topics:

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

Estimated Enrollment:	800
Study Start Date:	May 2006

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

Study ID Numbers:	2005_093
First Received:	June 14, 2006
Last Updated:	November 20, 2006
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 September 23, 2008