Brief Title
Immunogenicity and Safety of Adacel Polio Vaccine
Official Title
Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan
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 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Secondary Outcome
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Condition
Diphtheria
Intervention
TdcP-IPV vaccine
Study Arms / Comparison Groups
Study Group
Description: Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
132
Start Date
November 2008
Completion Date
July 2009
Primary Completion Date
April 2009
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
6 Years - 8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Monitor, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT00797511
Organization ID
TD525
Responsible Party
Sponsor
Study Sponsor
Sanofi
Study Sponsor
Medical Monitor, Study Director, Sanofi Pasteur Inc.
Verification Date
October 2012