Status:
UNKNOWN
An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster
Lead Sponsor:
Swedish Institute for Infectious Disease Control
Collaborating Sponsors:
MCM Vaccines B.V.
Statens Serum Institut
Conditions:
Tetanus
Diphtheria
Eligibility:
All Genders
14-15 years
Phase:
PHASE4
Brief Summary
Open-label, randomized, multi-centre study in which 400 subjects, divided into two groups, will receive Td5ap or Td1aP as a single injection. We will then describe the immune response and safety profi...
Detailed Description
The vaccines in the study are COVAXIS (Td5ap), Sanofi Pasteur Canada, and diTekiBooster (Td1aP), Statens Serum Institut, Denmark. The primary objective of the study is to describe the immune response...
Eligibility Criteria
Inclusion
- healthy subject
- 14-15 years old
- eligible for their school-leaving booster for DTP
- received a complete primary vaccination with a 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or Td5aP + IPV) as a booster at 5½ years of age
- informed consent form signed by the subject and parent(s)/legal representative
- subject understand and comply with the study procedures (i.e. able to read and write Swedish)
- female must provide an agreement that they are either sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).
Exclusion
- acute febrile illness or axillary temperature ≥38.0°C at the time of vaccination
- receipt of immunoglobulin within the previous 3 months, immunosuppression (e g evidence of impaired cell mediated immunity, receipt of immunosuppressant drugs within the previous 3 months or receipt of systemic corticosteroids given daily or on alternate days at ≥20 mg/day prednisone equivalent during \>14 days within the past 30 days)
- receipt of a non-study vaccine in the past 30 days
- evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine
- booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
- previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis
- hypersensitivity to any component of any of the study vaccines
- current participation in any other clinical trial or participation in any clinical trial in the previous month
- inability to adhere to the protocol, including plans to move from the area
- severe chronic disease
- family history of congenital or hereditary immunodeficiency
- any sever thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
- any medical condition, which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00870350
Start Date
April 1 2009
End Date
June 1 2010
Last Update
June 7 2010
Active Locations (1)
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1
Swedish Institute for Infectious Disease Control
Lund, Sweden, 221 85