Status:
COMPLETED
Immunogenicity and Safety of Adacel Polio Vaccine
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan. Subjects will receive one dose of the study vaccine at 6 to 8 ye...
Eligibility Criteria
Inclusion
- Aged 6 to 8 years on the day of inclusion
- Informed consent form signed by the parent(s) or another legally acceptable representative
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines
- Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire.
Exclusion
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected 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
- Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events.
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
- History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial
- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00797511
Start Date
November 1 2008
End Date
July 1 2009
Last Update
November 26 2012
Active Locations (1)
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1
Taipei, Taipei, Taiwan, 100