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.
Conditions
Interventions
Trade Name: COVAXIS
Pharmaceutical Form: Suspension for injection
Trade Name: diTekiBooster
Pharmaceutical Form: Suspension for injection
Sponsors
Swedish Institute for Infectious Disease Control (SMI)
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe in each vaccine arm the immune response to diphtheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap.;Secondary Objective: To describe the safety of a fifth dose of diphtheria, tetanus and pertussis vaccines in 14-15 year-old children by observing proportion of children with systemic and local adverse reactions. To describe pre-booster antibody levels against diphtheria tioxin, tetanus toxoid, pertussis toxin, FHA, pertactin and fimbriae 2/3. To describe the pre-booster and post-booster IgG and IgA levels against diphtheria toxin, tetanus toxoid, pertussis toxin, FHA, pertactin and fimbriae 2/3 in salivia. To describe in subpopulation the pre-booster and post-booster T cell immune responses as determined by the production of cytokines after stimulation with tetanus toxoid, pertussis toxin, FHA, and pertactin. To describe in a subpopulation the pre-booster and post-booster B cell immune responses as determined by the number of effector an memory B-cells after stimulation with tetanus toxoid, pertussis toxin, FHA, and pertactin.;Primary end point(s): Immune respons, IgG antibodies, to diphtheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin is investigated four weeks after immunization with Td1aP and Td5aP. | — |
Countries
Sweden
Outcome results
None listed