Clinical trial NCT00258908: Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
Official title: Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: ADACEL™
Tetanus
Diphteria
Acellular pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 115
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
timeFrame: Day 0 and Day 28 Post-vaccination
measure: Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
timeFrame: Day 0 and Day 28 post-vaccination
Secondary outcomes:
measure: Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination
timeFrame: Within 8 days of vaccination
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References: