E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis: Tick-borne-encephalitis |
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E.1.1.1 | Medical condition in easily understood language |
Tick-borne-encephalitis disease |
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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 investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization 5 year follow up) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:
• percentage of subjects with titers ≥ 10
• percentage of subjects with titers ≥ 2
• geometric mean titer (GMT) as measured by Neutralization Test (NT, in-house, Novartis Vaccines), from Day 0 as defined in protocol V48P4 to year 5 (± 90 days) after the first booster immunization with the new TBE vaccine.. |
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E.2.2 | Secondary objectives of the trial |
To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization 5 year follow up) and V48P4E2 (serological follow-up) in terms of:
• percentage of subjects with antibody concentrations ≥ detection limit/seroconversion limit
• geometric mean concentration (GMC)
• avidity determination for selected time points
as measured by ELISA (Enzygnost®, Dade Behring) at 5 years (± 90 days) after the first booster immunization with the new TBE vaccine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Individuals meeting all of the following criteria were eligible for enrollment into the study:
Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.
Informed consent was obtained for all the subjects before enrollment into the study. |
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E.4 | Principal exclusion criteria |
In this study subjects who received a booster immunization since termination of study V48P4E2 were not excluded. They were asked to consent that the information of the booster immunization could be implemented in the database for statistical reason and to use the serum samples of previous studies for avidity determination. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.percentage of subjects with titers ≥ 10 as measured by Neutralization Test (NT)
2. percentage of subjects with titers ≥ 2 as measured by NT
3. geometric mean titer (GMT) as measured by NT |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Day 0 as defined in protocol V48P4 to year 5 (± 90 days) after the first booster immunization with the new TBE vaccine. |
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E.5.2 | Secondary end point(s) |
1.percentage of subjects with antibody concentrations ≥ detection limit/ seroconversion limit as measured by ELISA
2. geometric mean concentration (GMC) as measured by ELISA
3. avidity determination for selected time pointsas measured by ELISA |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 5 years (± 90 days) after the first booster immunization with the new TBE vaccine |
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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 | 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 | Yes |
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) | 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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 0 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 15 |