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The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.
Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.
The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 (~12 months post filling) | Active Comparator | 6 mcg (~12 months post filling) |
|
| IC51 (~18 months post filling) | Active Comparator | 6 mcg (~18 months post filling) |
|
| IC51 (~24 months post filling) | Active Comparator | 6 mcg (~24 months post filling) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological | 6 mcg im. at day 0 and day 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary: 1. Geometric Mean Titers (GMT) at Day 56 | 56 days post 1st vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability | see above |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelyn Hatzenbichler | Valneva Austria GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Reisemedizin | Vienna | State of Vienna | 1090 | Austria | ||
| Universitätsklinikum Rostock |
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 Cohort 1 | vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling; |
| FG001 | IC51 Cohort 2 | vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling; |
| FG002 | IC51 Cohort 3 | vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling; |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 Cohort 1 | vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling; |
| BG001 | IC51 Cohort 2 | vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling; |
| 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 | Primary: 1. Geometric Mean Titers (GMT) at Day 56 | Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titer - Estimate | 56 days post 1st vaccination |
|
up to 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 Cohort 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subcutaneous abscess | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrin Dubischar-Kastner | Valneva Austria GmbH | +43120620 | 0 | info@valneva.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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| ID | Term |
|---|---|
| D022321 | Japanese Encephalitis Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Rostock |
| Rostock |
| 18057 |
| Germany |
| Berliner Zentrum Reise- und Tropenmedizin | Berlin | State of Berlin | 10117 | Germany |
| Withdrawal by Subject |
|
| Subject missed Visit 4 |
|
| BG002 | IC51 Cohort 3 | vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling; |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling; |
|
|
| Secondary | Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability | Not Posted | see above |
| 2 |
| 98 |
| 66 |
| 98 |
| EG001 | IC51 Cohort 2 | 1 | 103 | 58 | 103 |
| EG002 | IC51 Cohort 3 | 0 | 102 | 61 | 102 |
| Endometrial hyperplasia | Reproductive system and breast disorders |
|
| Hypertension | Vascular disorders |
|
| Tachycardia | Cardiac disorders |
|
| Vertigo | Ear and labyrinth disorders |
|
| Ocular Hyperaemia | Eye disorders |
|
| Abdominal Pain Upper | Gastrointestinal disorders |
|
| Dental Caries | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Enteritis | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Asthenia | General disorders |
|
| Fatigue | General disorders |
|
| Influenza Like Illness | General disorders |
|
| Injection Site Erythema | General disorders |
|
| Pyrexia | General disorders |
|
| Cystitis | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Rhinitis | Infections and infestations |
|
| Sinusitis | Infections and infestations |
|
| Subcutaneous Abscess | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Hepatic Enzyme Increased | Investigations |
|
| Iron Deficiency | Investigations |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders |
|
| Disturbance In Attention | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Dysuria | Renal and urinary disorders |
|
| Endometrial Hyperplasia | Reproductive system and breast disorders |
|
| Endometriosis | Reproductive system and breast disorders |
|
| Menorrhagia | Reproductive system and breast disorders |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue 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 |