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The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 | Experimental | 6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28 |
|
| JE-VAX | Active Comparator | given s.c. on Day 0, 7 and 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological | IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 | SCR: anti-JEV neutralizing antibody titer ≥1:10 | Day 56 |
| GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 | GMT: geometric mean of PRNT50 | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Events | until Day 56 | |
| Immunogenicity at Day 28 | Day 28 | |
| Immunogenicity at Day 56 for North America vs. Europe |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Kaltenboeck, Ph.D. | Valneva Austria GmbH | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 | IC51 |
| FG001 | JE-VAX | JE-VAX |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 | IC51 |
| BG001 | JE-VAX | JE-VAX |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 | SCR: anti-JEV neutralizing antibody titer ≥1:10 | Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan | Posted | Number | percentage of participants | Day 56 |
|
|
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numbers provided for safety population (N= 863)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC51 | IC51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Research | Intercell AG | +43 1 206 20 | 1175 | kdubischar-kastner@intercell.com |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| JE-VAX | Biological | JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28 |
|
| Day 56 |
| Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age | Day 56 |
| Lost to Follow-up |
|
| administrative reasons |
|
| Adverse Event |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Safety and Adverse Events | Not Posted | until Day 56 | Participants |
| Secondary | Immunogenicity at Day 28 | Not Posted | Day 28 | Participants |
| Secondary | Immunogenicity at Day 56 for North America vs. Europe | Not Posted | Day 56 | Participants |
| Secondary | Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age | Not Posted | Day 56 | Participants |
| Primary | GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 | GMT: geometric mean of PRNT50 | PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded. | Posted | Geometric Mean | Standard Deviation | titers | Day 56 |
|
|
|
| 1 |
| 428 |
| 217 |
| 428 |
| EG001 | JE-VAX | JE-VAX | 0 | 435 | 213 | 435 |
| Fatigue | General disorders |
|
| Influenza like Ilness | General disorders |
|
| Pyrexia | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
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| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |