E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The condition under investigation is the naturally aging immune system. The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group. |
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E.1.1.1 | Medical condition in easily understood language |
The condition under investigation is the naturally aging immune system and its immune responses to a booster vaccination. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 |
Testing the difference of the JEV-antibody titre increase between young and elderly adults between visit 1 (before booster vaccination) and visit 3 (6 weeks after booster vaccination). |
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E.2.2 | Secondary objectives of the trial |
Testing the difference of the JEV-antibody titre increase between young and elderly adults between visit 1 (before booster vaccination) and up to visit 4 (6 months after booster vaccination).
Testing cellular immunity (cytokine production after JEV as well as TBE stimulation) on visit 1, 2 (one week after booster immunisation) and 3 between both age groups.
Testing of surface markers of different T and B cell subsets before and after JE-booster vaccination (on visit 1-3) in comparison between both age groups.
Testing TBE-antibody titres before and after JE-booster vaccination (on visit 1-4) in both age groups.
Testing CMV serology at visit 1 in both age groups.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- participation in the preceeding study "IXIARO®-senescence" (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60. - good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM) - willingness to sign written informed consent
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E.4 | Principal exclusion criteria |
- Already received an booster (3rd dose) of IXIARO ® - past infection with the JEV - yellow fever vaccination within the last 6 months - TBE vaccination within the last 30 days - current acute infection
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E.5 End points |
E.5.1 | Primary end point(s) |
Fold-increase of JEV-antibody titre between visit 1 (prior booster vaccination) to visit 3 ( 6 weeks after booster vaccination) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
visit 1 (prior booster vaccination) and visit 3 (6 weeks after booster vaccination) |
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E.5.2 | Secondary end point(s) |
JEV-antibody titre before booster vaccination with IXIARO® (visit 1) as well as 7 days (visit 2) and 6 months (visit 4) after booster vaccination.
Cellular immunity (cytokine production after JEV as well as TBE stimulation) before booster vaccination with IXIARO® (visit 1) as well as 7 days (visit 2) and 6 weeks (visit 3) after booster vaccination.
Determination of surface markers of different T and B cell subsets before booster vaccination with IXIARO® (visit 1) as well as 7 days (visit 2) and 6 weeks (visit 3) after booster vaccination.
Testing TBE-antibody titers before and after JE-booster vaccination (on visit 1-4).
Correlation of CMV serology (visit 1) with humoral and cellular responses.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
visit 1 (prior booster vaccination) visit 2 (7 days after booster vaccination) visit 3 (6 weeks after booster vaccination) visit 4 (6 months after booster vacciantion) |
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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 | 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 | 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.8.3 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |