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
- Conditions
- Two vaccines against diphtheria, tetanus and pertussis will be tested and immune respons investigated in 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 5,5 year of age.
- Registration Number
- EUCTR2008-008195-13-SE
- Lead Sponsor
- Swedish Institute for Infectious Disease Control (SMI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
F.1.3.1 Number of subjects for this age range
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
11. Family history of congenital or hereditary immunodeficiency
12. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
13. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
14. Pregnant woman (positive pregnancy test), nursing mothers and/or women planning pregnancy during the course of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method