Prophylaxis
Conditions
Interventions
Trade Name: REPEVAX
Product Name: REPEVAX
Pharmaceutical Form: Injection*
Trade Name: COVAXiS
Product Name: COVAXiS
Pharmaceutical Form: Injection*
Trade Name: IPV Merieux
Product Name: IPV Merieux
Sponsors
Sanofi Pasteur Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eligible to receive REPEVAX® or COVAXiS® in accordance with German recommendations for a booster dose of acellular pertussis vaccine at 9-17 years of age. The last booster dose should have been administered at least 5 years ago. 2. Signed and dated informed consent and assent form (as applicable) that is obtained prior to the first study intervention. 3. Judged to be in good health on the basis of reported medical history and history-directed physical examination. 4. Either simultaneous participation in the TRI05 study or documented vaccination with four doses of acellular pertussis vaccine. 5. Oral temperature =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or nursing a child. 2. Known or suspected primary or acquired disease of the immune system. 3. Malignancy, allergy immunotherapy or immunosuppressive therapy. 4. Receipt of any pertussis, diphtheria or tetanus-containing vaccine within the past five years. 5. Any unstable significant underlying chronic disease. 6. Known impairment of neurological function, currently active seizure disorder or currently requiring medication for seizures. 7. Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last ten years. 8. Receipt of blood products or immunoglobulin within the previous three months. 9. Known or suspected allergy to any of the vaccines or vaccine components. 10. Daily use of non-steroidal anti-inflammatory drugs. 11. Receipt of any vaccine or investigational product within 30 days prior to enrollment or planning to receive another vaccine within 28 days after having received the study vaccine. 12. Drug addiction (alcoholism, intravenous drug use) 13. Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms. 14. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine. 15. History of immediate anaphylaxis, encephalopathy within seven days or seizure within three days after receiving diphtheria, tetanus or pertussis vaccine. 16. Planned participation in another interventional clinical trial during the present trial period (participation in the TRI05 study excepted). 17. Thrombocytopenia or coagulation disorder that would pose a contraindication to an intramuscular vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the pertussis-specific humoral and cellular immunity after vaccination with REPEVAX® or COVAXiS® or COVAXiS® + IPV Merieux® among three groups: Group A: Adolescents 10-14 years of age who participated in study 371-03/01 and therefore have already received five doses of acellular pertussis vaccine and that simultaneously participate in the TRI05 study where they receive either REPEVAX® or COVAXiS® + IPV Merieux® depending on their randomization group. Group B: Adolescents 10-14 years of age that previously received four doses of acellular pertussis vaccine. Group C: Adolescents 10-14 years of age who previously received four doses of whole-cell pertussis vaccine and have not yet received acellular pertussis vaccine and that simultaneously participate in the TRI05 study where they receive either REPEVAX® or COVAXiS® + IPV Merieux® depending on their randomization group. ;Secondary Objective: Review of the correlation between the individual side effects of the vaccination and the individual immune response through combined analysis of study data from protocols 371-03/01, TRI05 and PERTIMMUN06.;Primary end point(s): Measurement of the following blood parameters previous and one month after the pertussis booster vaccination: - IgG titer against pertussis toxin, pertactin and filamentous hemagglutinin - Vitality of peripheral mononuclear cells - Reaction capacity of the peripheral lymphocytes to the pertussis-specific antigens pertussis-toxin and filamentous hemagglutinin - Quantitative measurement of cytokines (IL-2, IL-4, IL-5, IL-10, TNF-a, INF-?) - Flow cytometric analysis of lymphocyte activation markers, intracellular cytokines and Th1/Th2 typical transcription factors. | — |
Countries
Germany
Outcome results
None listed