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Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00258908
First received: November 24, 2005
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.

To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 Post-vaccination ] [ Designated as safety issue: No ]
    Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.

  • Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.


Secondary Outcome Measures:
  • Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination [ Time Frame: Within 8 days of vaccination ] [ Designated as safety issue: Yes ]
    The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose


Enrollment: 115
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, Intramuscular
    Other Name: ADACEL™
  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
  • Informed consent form (ICF) signed by parent(s)/legal representative
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus toxoids and whole cell Pertussis vaccine (DTP)
  • Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire

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 diphtheria and tetanus toxoids and acellular pertussis (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 Oral Poliomyelitis Vaccine [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 Human Immunodeficiency Virus (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
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: NCT00258908

Locations
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00258908     History of Changes
Other Study ID Numbers: TD521
Study First Received: November 24, 2005
Results First Received: April 7, 2009
Last Updated: January 10, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Sanofi:
ADACEL™
Tetanus
Diphteria
Acellular pertussis

Additional relevant MeSH terms:
Diphtheria
Actinomycetales Infections
Bacterial Infections
Corynebacterium Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on November 20, 2014