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The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years
This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.
Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 2 x 6 mcg | Active Comparator | 2 x 6 mcg (microgram) |
|
| IC51 1 x 12 mcg | Active Comparator | 1 x 12 mcg (microgram) |
|
| IC51 1 x 6 mcg | Active Comparator | 1 x 6 mcg (microgram) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| SCR (Seroconversion Rate) at Day 56 | Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer | day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| SCR at Day 10, 28 and 35 | Day 10, 28 and 35 | |
| GMT at Day 10, 28, 35 and 56 | Day 10, 28, 35 and 56 | |
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Eder, Mag. | Valneva Austria GmbH | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 2 x 6 mcg | 2 x 6 mcg (microgram) |
| FG001 | IC51 1 x 12 mcg | 1 x 12 mcg (microgram) |
| FG002 | IC51 1 x 6 mcg | 1 x 6 mcg (microgram) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 2 x 6 mcg | 2 x 6 mcg (microgram) |
| BG001 | IC51 1 x 12 mcg | 1 x 12 mcg (microgram) |
| 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) at Day 56 | Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer | The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation | Posted | Number | 95% Confidence Interval | percentage of participants | day 56 |
|
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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 2 x 6 mcg | 2 x 6 mcg (microgram) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Research | Intercell AG | +43 1 206 20 | 0 | 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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AEs, Local and systemic tolerability, Safety laboratory parameters |
| Study duration |
| BG002 |
| IC51 1 x 6 mcg |
1 x 6 mcg (microgram) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Baseline Characteristics are based on Safety Population: all randomized subjects who received at least one vaccination, analysed using the treatment actually received. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | SCR at Day 10, 28 and 35 | Not Posted | Day 10, 28 and 35 |
| Secondary | GMT at Day 10, 28, 35 and 56 | Not Posted | Day 10, 28, 35 and 56 |
| Secondary | Safety | AEs, Local and systemic tolerability, Safety laboratory parameters | Not Posted | Study duration |
| 0 |
| 125 |
| 78 |
| 125 |
| EG001 | IC51 1 x 12 mcg | 1 x 12 mcg (microgram) | 1 | 125 | 82 | 125 |
| EG002 | IC51 1 x 6 mcg | 1 x 6 mcg (microgram) | 0 | 124 | 78 | 124 |
| Influenza like illness | General disorders |
|
| Fatique | General disorders |
|
| Headache | Nervous system 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 |