E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Japanese Encephalitis (JE) |
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E.1.1.1 | Medical condition in easily understood language |
healthy volunteers "Japanese encephalitis virus" |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014596 |
E.1.2 | Term | Encephalitis Japanese B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023120 |
E.1.2 | Term | Japanese B viral encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023123 |
E.1.2 | Term | Japanese encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023122 |
E.1.2 | Term | Japanese B virus encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023119 |
E.1.2 | Term | Japanese B encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions. |
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E.2.2 | Secondary objectives of the trial |
1- To assess the immunogenicity of the JEV vaccine IC51 in terms of Geometric Mean Titers (GMTs) and Seroconversion Rates (SCRs) at Day 56 in a pediatric population from endemic regions.
2- To establish the appropriate IC51 dose, 0.25 ml or 0.5 ml, for subjects aged ≥ 3 to < 12 years.
3- To assess age-dependent differences in the immunogenicity and safety profile of IC51.
4- To assess differences in the safety and immunogenicity profile of IC51 in subjects with no baseline immunity and subjects with pre-existing immunity against JEV and Dengue virus (DENV).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 Male or female healthy children and adolescents aged ≥ 2 months to < 18 years at the time of first vaccination.
2 Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
3 Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche). For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4.
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E.4 | Principal exclusion criteria |
1- Clinical manifestation of Japanese Encephalitis
2- History of Flavivirus vaccination (including any investigational vaccines)
3- History of vaccination with Prevnar® (only for children aged < 1 year) and HAVRIX®720
4- History of immunodeficiency or immunosuppressive therapy
5- Known HIV, HBV or HCV infection
6- History of hypersensitivity reactions to other vaccines
7- Acute febrile infection at each visit during which the subject receives a vaccination
8- For children aged ≥ 6 months at first vaccination, active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to one week after the second IC51 vaccination. For children aged < 6 months, active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
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E.5 End points |
E.5.1 | Primary end point(s) |
1- Rate of subjects with serious adverse events (SAEs) and medically attended adverse events (AEs) until Day 56 after the first vaccination |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after the end of the study |
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E.5.2 | Secondary end point(s) |
1- GMTs for JEV neutralizing antibodies measured using a validated Plaque Reduction Neutralization Test (PRNT) and SCR as defined by percentage of subjects with PRNT50 titers of ≥ 1:10 at Days 0 and 56 and at Month 7
2- Rate of subjects with SAEs and medically attended AEs up to Month 7 after the first vaccination
3- Rate of subjects with solicited local and systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination (except for Month 7)
4- Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7 after the first vaccination
5- Rate of subjects with abnormal laboratory parameters (hematology, serum chemistry, urinalysis) up to Day 56 and up to Month 7 after the first vaccination
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after the end of the study |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity (limited to a subgroup) |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
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 | 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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Overall study duration (First subject in - last subject last visit) is estimated to be 16 months. |
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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 years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |