Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 Batch A | Active Comparator |
| |
| IC51 Batch B | Active Comparator |
| |
| IC51 Batch C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese Encephalitis purified inactivated vaccine | Biological | IC51 6 mcg i.m. injection on Day 0 and Day 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Rate | Day 56 | |
| Safety and Adverse Events | Day 56 |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole Haas | Valneva Austria GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie | Vienna | 1090 | Austria | |||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IC51 Batch IC51/07E/006A | |
| FG001 | IC51 Batch IC51/07E/007A | |
| FG002 | IC51 Batch IC51/07E/008A |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IC51 Batch IC51/07E/006A | |
| BG001 | IC51 Batch IC51/07E/007A | |
| BG002 | IC51 Batch IC51/07E/008A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody | Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting. | Posted | Mean | Standard Deviation | titers | Day 56 |
|
Not provided
389 subjects were randomized, 2 of them were not treated
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC51 Batch IC51/07E/006A |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Research | Intercell AG | +43 1 206 20 | 1175 | kdubischar-kastner@intercell.com |
Not provided
| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Berliner Zentrum Reise- und Tropenmedizin |
| Berlin |
| 10117 |
| Germany |
| Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin | Munich | 80802 | Germany |
| Klinik und Poliklinik für Innere Medizin der Universität Rostock | Rostock | 18057 | Germany |
| Protocol Violation |
|
| Lost to Follow-up |
|
| administrative reason |
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Seroconversion Rate | Not Posted | Day 56 |
| Secondary | Safety and Adverse Events | Not Posted | Day 56 |
| 2 |
| 130 |
| 64 |
| 130 |
| EG001 | IC51 Batch IC51/07E/007A | 1 | 129 | 74 | 129 |
| EG002 | IC51 Batch IC51/07E/008A | 0 | 128 | 74 | 128 |
| Tubo-Ovarian Abscess | Infections and infestations |
|
| Humerus Fracture | Injury, poisoning and procedural complications |
|
| Vertigo | Ear and labyrinth disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Abdominal Pain Upper | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Influenza Like Illness | General disorders |
|
| Injection Site Haematoma | General disorders |
|
| Injection Site Pain | General disorders |
|
| Pyrexia | General disorders |
|
| Bronchitis | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Rhinitis | Infections and infestations |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
Not provided
| 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 |