E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Five year follow-up of healthy adults already vaccinated in a previous trial |
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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 |
1) To yearly describe the anti-vaccinia antibody persistence up to five years post VVL04 vaccination. 2) To follow-up the long-term safety up to five years post VVL04 vaccination |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Subject vaccinated and who completed the Phase II VVL04 trial. 2) Informed consent form signed. 3) Subject able to attend all scheduled visits and to comply with all trial procedures. 4) Subject entitled to national social security. |
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E.4 | Principal exclusion criteria |
1) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity: 1) Neutralizing Ab titers at 12, 24, 36, 48, and 60 months post VVL04 vaccination (i.e. M12, M24; M36, M48, and M60). 2) Titer ratio: M12/Day 28*, M24/M12, M36/M24, M48/M36, and M60/M48. 3) Persistence of detectable neutralizing Ab titer, i.e. ≥ 10 (1/dil) on M12, M24; M36, M48, and M60. *D28 titers are measured in VVL04 and, after M12, annual titers will be compared to previous year only
Safety: 1) Evolution of smallpox vaccine reactions experienced by subjects during or after VVL04. 2) Occurrence of:· - Any SAE related to smallpox vaccination - Other specific events such as: - cardiac events such as myocarditis, myopericarditis, pericarditis, ischemic heart disease (including angina pectoris and myocardial infarction) - neurological events such as encephalitis and seizure - cutaneous events such as degenerescence of the scar at or near the vaccination site 3) Pregnancy (including outcome) |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | Yes |
E.7.1.3.1 | Other trial type description |
lonf-term follow-up of a phase II trial |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | 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
|
Last subject last visit (i.e. 4 years after the M12 visit) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |