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A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00109330
First received: April 27, 2005
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

Condition Intervention Phase
Diphtheria
Tetanus
Acellular Pertussis
Biological: Combined diphtheria, tetanus, acellular pertussis vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Enrollment: 4116
Study Start Date: November 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:
A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine
  Eligibility

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion Criteria:

  • Use of any other investigational drug or vaccine 30 days preceding study vaccination.
  • Chronic administration of immunosuppressants.
  • Administration of pre-school DTP vaccine within previous 5 years.
  • Administration of Td booster within previous 10 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109330

  Show 44 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 776423/001
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 776423/001
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 776423/001
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 776423/001
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 776423/001
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 776423/001
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00109330     History of Changes
Other Study ID Numbers: 776423/001 
Study First Received: April 27, 2005
Last Updated: September 8, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Prevention of Diphtheria, Tetanus, Pertussis

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016