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Immunogenicity and Safety of ADACEL™ in Taiwan
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00258908
  Purpose

To assess the immunogenicity profile of ADACEL (TdacP vaccine) one month after administration.

To describe the safety profile of ADACEL (TdacP vaccine) when given as a fifth dose.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immune response to Adacel vaccine. [ Time Frame: Day 28, post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
    0.5 mL, IM
  Eligibility

Ages Eligible for Study:   6 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Aged from 6 to 8 years on the day of inclusion

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of DTP or DTaP vaccine, one of the following adverse events

    1. encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose
    2. temperature of > 40.5°C within 48 hours not due to another identifiable cause
    3. collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
    4. persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours
    5. seizure with or without fever occurring within 3 days
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past 3 months
  • Any vaccination in the 4 weeks preceding the trial vaccination (except OPV)
  • Any vaccination planned during the present trial period (except OPV)
  • History of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically)
  • Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine
  • Clinical or serological evidence of systemic illness including Hepatitis B, C or HIV
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures
  • Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258908

Locations
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur, Inc. ( Medical Director )
Study ID Numbers: TD521
Study First Received: November 24, 2005
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00258908  
Health Authority: Taiwan: Department of Health

Keywords provided by Sanofi-Aventis:
Tetanus;
Diphteria;
Acellular pertussis;

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough
Diphtheria
Clostridium Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009