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Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

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ClinicalTrials.gov Identifier: NCT00258908
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : June 8, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE November 24, 2005
First Posted Date  ICMJE November 28, 2005
Results First Submitted Date  ICMJE April 7, 2009
Results First Posted Date  ICMJE June 8, 2009
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE November 2005
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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 ]
    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 ]
    GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00258908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination [ Time Frame: Within 8 days of vaccination ]
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
Official Title  ICMJE Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
Intervention  ICMJE Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
0.5 mL, Intramuscular
Other Name: ADACEL™
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2009)
115
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00258908
Other Study ID Numbers  ICMJE TD521
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP