E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination of vaccinia-naive healthy adults (18-25 years old) |
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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 estimate the smallpox vaccination take rate in naïve healthy adults. |
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E.2.2 | Secondary objectives of the trial |
1) To describe local signs and symptoms of the take. 2) To describe the safety of the vaccine in naïve healthy adults 3) To describe the antibody response to vaccination on D0 and D28 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients aged 18 to 25 years on the day of screening 2. Informed consent form signed 3. Able to attend all scheduled visits and to comply with all trial procedures 4. For a woman, inability to bear a child or negative serum pregnancy test performed at screening (checked at V01) 5. Subject entitled to national social security 6. Subject registered in the French file of healthy volunteers in clinical trials 7. For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least three months prior to screening to three months following trial vaccination 8. For a woman, inability to bear a child or negative urine pregnancy test
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E.4 | Principal exclusion criteria |
Exclusion criteria 1 to 27 will be checked at screening and on D0: 1. Previous smallpox vaccination confirmed by vaccination record or typical scar 2. Participation in another clinical trial in the three months preceding the trial vaccination 3. Planned participation in another clinical trial during the present trial period 4. Chronic illness at a stage that could interfere with trial conduct or completion 5. Breast-feeding 6. Allergy to any known components of vaccinia immune globulin or previous allergic reaction to immunoglobulins 7. Systemic hypersensitivity to eggs or to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine 8. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or any treatment including corticosteroids (systemic, topical, ophthalmic) 9. Treatment with antiviral drugs (interferon, vidarabine, acyclovir, etc.) within one month before vaccination 10. History of organ or bone marrow transplant 11. History of skin disorders or atopy (such as progressive eczema, eczema, atopic dermatitis, Darier’s disease, severe acnea, etc.) 12. History of autoimmune disease (multiple sclerosis, lupus, etc.) in the subject’s parents, siblings or children 13. History or current cardiac disease: ECG abnormalities, pericarditis, myopericarditis, myocardial infarction/heart attack, angina pectoris, congestive heart failure, cardiomyopathy, arrhythmia, stroke or transient ischemic attacks, or chest pain or shortness of breath with activity (such as walking up stairs), or other coronary artery disease and heart conditions under the care of a physician and associated with a heart condition, or family history of sudden death before the age of 50 years 14. History or current central nervous system disease: neurodegenerative, infectious, or progressive tumoral disease, or epilepsy 15. Subject having three or more major risk factors, including: current tobacco use, hypertension, hypercholesterolemia, hypertriglyceridemia, diabetes mellitus, or family history of heart disease (a heart condition before age 50 in a parent, brother, or sister) 16. Ongoing acute infectious disease 17. Blood or blood-derived products received in the past six months 18. Any vaccination with a live-attenuated vaccine within the 60 days preceding the trial vaccination 19. Any vaccination (other than a live-attenuated vaccine) in the four weeks preceding the trial vaccination 20. Vaccination planned in the eight weeks following the trial vaccination 21. Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures 22. Planned or foreseeable close contact after vaccination with infants of less than 12 months of age, or with immunosuppressed persons, pregnant and/or lactating woman, or with persons known to have chronic eczema, or severe skin disorders until the crust separates, leaving a permanent scar at the vaccination site 23. Planned practice of contact sports or water sports after vaccination until the crust separates, leaving a permanent scar at the vaccination site 24. Cutaneous lesion near the vaccination site 25. Apparent lack of personal hygiene 26. Lack of understanding of the questionnaire 27. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
The following exclusion criteria will be checked on D0 only: 28. HIV, hepatitis B (Ag HBs) or hepatitis C seropositivity (screening tests) 29. Abnormal laboratory values for hematological parameters or cardiac enzymes (screening tests) 30. Any medical disease / condition (severe skin problems or immune system problems of subject or their close contacts) according to the questionnaire given at the screening visit 31. Febrile illness (oral temperature ≥ 37.5°C, rectal equivalent temperature ≥38.0°C) on the day of vaccination 32. Acute intercurrent illness 33. Absence or unreturned completed questionnaire |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the take for each subject on D9 (Day), D14, D21, and D28. The take is defined as the occurrence of a post-vaccination pock at the vaccination site (a pock is a typical major cutaneous lesion [erythematous papule, vesicle, or pustule]). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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.8.5 | 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 | Information not present in EudraCT |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |