An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster (NCT00870350) | Clinical Trial Compass
UnknownPhase 4
An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster
Sweden400 participantsStarted 2009-04
Plain-language 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 profile of the combined vaccine booster.
Who can participate
Age range14 Years – 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 vacci…
What they're measuring
1
to describe in each arm the immune response to diptheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap
Timeframe: 42 days
Trial details
NCT IDNCT00870350
SponsorSwedish Institute for Infectious Disease Control