E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Development of immune assays, which can predict the protective efficacy of different pertussis vaccine candidates Date: 2008-12-10 Objectives: To develop methods for determination of cellular immune responses against pertussis antigens in preparation for a clinical trial of a new pertussis vaccine candidate intended for use in newborns.
Title: Studie av boostervaccination med dTap vid 14-15-års ålder med avseende på cytokinmönster och att bedöma T-cellssvar för pertussis-antigen Date: 2008-12-10 Objectives: Att utvärdera boostervaccination med difteri-stelkramp-acellulärt kikhostevaccin (dTap) vid 14-15-års ålder med avseende på cytokinmönster. Att söka bedöma T-cellssvar för pertussis-antigen.
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E.3 | Principal 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). |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial will be the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |