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The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC51 Group A | Active Comparator | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
|
| IC51 Group B | Active Comparator | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
|
| IC51 Group C | Active Comparator | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological | 6 mcg, intramuscularly [i.m.], 0.5 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT for Anti-JEV Neutralizing Antibody | Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2. | day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability | study duration |
| SCR for Anti-JEC Neutralizing Antibody Titer | day 56 |
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Main Inclusion Criteria:
Main 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 Group A | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| FG001 | IC51 Group B | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| FG002 | IC51 Group C | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population, i.e. subjects who received at least one vaccination
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 Group A | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| BG001 | IC51 Group B | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | numbers based on Safety Population: subjects with at least one vaccination |
| 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 | GMT for Anti-JEV Neutralizing Antibody | Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2. | Per Protocol Population (observed values) | Posted | Geometric Mean | 95% Confidence Interval | GMT | day 56 |
|
up to Month 6
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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 Group A | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reflux Oesophagitis | Gastrointestinal 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 | 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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| Pregnancy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| administrative |
|
| BG002 | IC51 Group C | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | numbers based on Safety Population: subjects with at least one vaccination | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | IC51 Group C | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
|
|
| Secondary | Safety | Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability | Not Posted | study duration | Participants |
| Secondary | SCR for Anti-JEC Neutralizing Antibody Titer | Not Posted | day 56 | Participants |
| 3 |
| 212 |
| 102 |
| 212 |
| EG001 | IC51 Group B | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches | 2 | 213 | 124 | 213 |
| EG002 | IC51 Group C | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches | 5 | 211 | 114 | 211 |
| Acute Abdomen | Gastrointestinal disorders |
|
| Cholecystitis Acute | Hepatobiliary disorders |
|
| Erysipelas | Infections and infestations |
|
| Herpes Zoster | Infections and infestations |
|
| Peritonsillar Abscess | Infections and infestations |
|
| Respiratory Tract Infection | Infections and infestations |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Intracranial Aneurysm | Nervous system disorders |
|
| Renal Colic | Renal and urinary disorders |
|
| Fatigue | General disorders |
|
| Influenza Like Ilness | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Rhinitis | Infections and infestations |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Acute Tonsillitis | Infections and infestations |
|
| Gastroenteritis | Infections and infestations |
|
| Back Pain | Musculoskeletal and connective 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 |