E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
No medical condition, healthy subjects. |
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E.1.1.1 | Medical condition in easily understood language |
No medical condition, healthy subjects. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 evaluate the persistence of antibody response to a booster vaccine starting 6 years after the booster administration and following subjects up to 10 years after first booster administration. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. subjects who signed informed consent form (ICF) prior to study entry
2. subjects who have completed study V48P7E1 and who received in a parent V48P7 study one of the following schedules: rapid (R), conventional (C), or accelerated conventional (AC).
3. subjects who are in stable health as determined by medical history, physical examination, and clinical judgment of the investigator.
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E.4 | Principal exclusion criteria |
1. who are unwilling or unable to give written informed consent to participate in the study.
2. who are perceived to be unreliable or unavailable for the duration of the study period.
3. who has NT titer below 10 before visit 17 (first study visit within this protocol).
4. who has received a TBE or other flavivirus vaccine after completion of the V48P7E1 and before starting V48P7E2 study.
5. who had a previous confirmed TBE infection or were exposed (documented infection) to other flaviviruses.
6. who received in the parent V48P7 study a primary immunization according to the modified conventional (MC) schedule.
7. who have received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
8. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study.
9. who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
10. who have chronic immunosuppressive conditions
11. who have been treated with:
- immunosuppressants or systemic corticosteroids within the past 4 weeks or during the study period, except short term use of topical corticosteroids
- immunoglobulins, whole blood or plasma derivatives up to 3 months before enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
▫ Percentages of Subjects with detectable TBE Neutralizing Antibody Titers ≥ 2 and
≥ 10 as measured by NVD NT assay
▫ Geometric Mean Antibody Titers and Geometric Mean Ratios (GMRs) as
measured by NVD NT assay calculated for each of the different schedule groups |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The immunogenicity endpoints will be evaluated at year 6, 7, 8, 9 and 10. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |