E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibody responses to tetanus toxoid. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060308 |
E.1.2 | Term | Tetanus antibody positive |
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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 demonstrate that a booster dose of Tdap-IPV vaccine is as immunogenic as a booster dose Tetanus monovalent vaccine in terms of anti-tetanus seroprotection rate (defined as percentage of subjects with anti-tetanus antibody titre (measured by Enzyme-Linked ImmunoSorbent Assay (ELISA) ≥0.1 IU/mL) 10 days after vaccination. |
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E.2.2 | Secondary objectives of the trial |
To describe the Geometric Mean Titre (GMT) for tetanus antibodies in both groups at Day 0, Day 10 and Day 28 and the seroprotection rate at Day 28.
To describe the safety profile of the two vaccines (descriptive objective). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects have to meet all the following criteria to be eligible for inclusion: 1. Healthy adults aged ≥18 years, 2. Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence), 3. Negative urine pregnancy test for female subjects of child-bearing potential. A female subject who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period, 4. Subject affiliated to a health social security system (for France only), 5. Subject having signed the informed consent form prior to participation in the study, 6. Subject able to attend all scheduled visits and to comply with all study procedures. |
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E.4 | Principal exclusion criteria |
Subjects meeting at least one of the following criteria will be ineligible for inclusion: 1. Acute severe illness or fever (≥38.0°C) within the last 3 days, 2. Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde), 3. Anaphylactic or other allergic reactions to a previous dose of a vaccine containing diphtheria or tetanus toxoids or poliomyelitis viruses or pertussis (acellular or whole cell), 4. Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine, 5. Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens, 6. Progressive or unstable neurological disorder, uncontrolled seizures or progressive encephalopathy not stabilized, 7. Known malignant disease; Note: Subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs), subjects with skin cancer who are not receiving radiation therapy or chemotherapy and subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrolment. 8. Immunosuppressive therapy: − High dose (≥ 20 mg/day prednisone equivalent) systemic (≥ 14 days) corticosteroid treatment daily or on alternate day within the last 28 days (inhaled corticosteroids allowed), − Chemotherapeutic agents used to treat cancer or other conditions, − Treatments associated with organ or bone marrow transplantation. 9. Immune dysfunction caused by a medical condition, or any other cause (e.g. congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma or generalized malignancy), 10. Known severe thrombocytopenia or coagulation disorder contraindicating an intramuscular injection, 11. Administration of blood products including immunoglobulins within the last 90 days or planned before Visit 3, 12. Recent administration of a live vaccine (≤28 days) or an inactivated vaccine (≤14 days) or vaccination planned before Visit 3, 13. For female subjects, pregnancy (positive pregnancy test before first blood sample) or breast-feeding through Visit 3, 14. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent, 15. Planned participation in another clinical study during the present study period, 16. Volunteer having been paid more than 4 500€ to take part in biomedical research during the previous 12 months (for France only). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the anti-tetanus seroprotection rate (defined as percentage of subjects with anti-tetanus antibody titre (ELISA) ≥0.1 IU/mL) 10 days after vaccination. |
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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 | No |
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 | Information not present in EudraCT |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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
|
End of data collection including availability of serology results. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |