EUCTR2008-008195-13-SE
Active, not recruiting
Not Applicable
An immunogenicity and safety study of combined adsorbed tetanus, low dose diphtheria and acellular pertussis vaccine (Td5ap and Td1aP) given as a school-leaving booster to 14-15-year-old children primed with a five component acellular pertussis vaccine at 3, 5 and 12 months of age, and a booster dose at 5½ years of age. - Tdap Booster study
Swedish Institute for Infectious Disease Control (SMI)0 sitesDecember 23, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Swedish Institute for Infectious Disease Control (SMI)
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy subject of either gender aged 14 to 15 years eligible for their school\-leaving booster for diphtheria, tetanus and pertussis.
- •2\. A child who received a complete primary vaccination with 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.
- •3\. Informed consent form signed by the subject and parent(s)/legal representative.
- •4\. Subject understand and comply with the study procedures.
- •5\. Female must provide an agreement that they either are sexually continent or practice adequate contraceptive methods (intra\-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •1\. Acute febrile illness and/or axillary temperature \=38\.0°C at the time of vaccination
- •2\. Immunosuppression (e.g. evidence of impaired cell mediated immunity,, receipt of immunoglobulin, immunosuppressant drugs or systemic corticosteroides within the previous 3 months)
- •3\. Receipt of a live vaccine within the last 28 days
- •4\. Evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole\-cell or acellular pertussis vaccines).
- •5\. Booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
- •6\. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis.
- •7\. Hypersensitivity to any component of any of the study vaccines
- •8\. Current participation in any other clinical trial or participation in any clinical trial in the previous month
- •9\. Inability to adhere to the protocol, including plans to move from the area.
- •10\. Severe chronic disease
Outcomes
Primary Outcomes
Not specified
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