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The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC51 | Biological | IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion Rate | at Month 12 after booster |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Events | up to Month 12 after booster | |
| Seroconversion | at D28 and Month 6 after booster | |
| Geometric Mean Titer |
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Main Inclusion Criteria:
Main Exclusion Criteria:
• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Eder | Valneva Austria GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie | Vienna | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21288804 | Derived | Eder S, Dubischar-Kastner K, Firbas C, Jelinek T, Jilma B, Kaltenboeck A, Knappik M, Kollaritsch H, Kundi M, Paulke-Korinek M, Schuller E, Klade CS. Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO(R), IC51. Vaccine. 2011 Mar 21;29(14):2607-12. doi: 10.1016/j.vaccine.2011.01.058. Epub 2011 Feb 1. |
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subjects participating in study IC51-309 without major Protocol Deviations
subjects participating in preceeding study IC51-309 were contacted. First Subject In December 2007, Last Subject In March 2008; study sites: center of pharmacology and travel clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | IC51 Booster Group | IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC51 Booster Group | IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309 |
| 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 | Seroconversion Rate | Intent-To-Treat Population which includes all subjects entered into the study who received the booster vaccination | Posted | Number | 95% Confidence Interval | percent | at Month 12 after booster |
|
|
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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 Booster Group | IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (10.1) |
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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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| D28, Month 6 and Month 12 after booster |
| Zentrum für Reisemedizin, Dependance für klinische Studien |
| Vienna |
| Austria |
| Berliner Zentrum Reise- und Tropenmedizin | Berlin | Germany |
| personal reason |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Safety and Adverse Events | Not Posted | up to Month 12 after booster |
| Secondary | Seroconversion | Not Posted | at D28 and Month 6 after booster |
| Secondary | Geometric Mean Titer | Not Posted | D28, Month 6 and Month 12 after booster |
| 8 |
| 198 |
| 96 |
| 198 |
| Injury | Injury, poisoning and procedural complications | MedDRA (10.1) |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA (10.1) |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA (10.1) |
|
| Epilepsy | Nervous system disorders | MedDRA (10.1) |
|
| Cystitis Noninfective | Renal and urinary disorders | MedDRA (10.1) |
|
| Breast Cosmetic Surgery | Surgical and medical procedures | MedDRA (10.1) |
|
| Thrombosis | Vascular disorders | MedDRA (10.1) |
|
| Influenza Like Illnes | General disorders | MedDRA (10.1) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) |
|
| Headache | Nervous system disorders | MedDRA (10.1) |
|
| Hypochronic Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (10.1) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) |
|
| Pyrexia | General disorders |
|
| Allergy To Animal | Immune system disorders | MedDRA (10.1) |
|
| Acute Tonsillitis | Infections and infestations |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) |
|
| Cystitis | Infections and infestations | MedDRA (10.1) |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) |
|
| Influenza | Infections and infestations | MedDRA (10.1) |
|
| Pharyngitis | Infections and infestations | MedDRA (10.1) |
|
| Rhinitis | Infections and infestations | MedDRA (10.1) |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.1) |
|
| Limb Injury | Injury, poisoning and procedural complications |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (10.1) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
|
| Dysmenorrhoea | Reproductive system and breast disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
|
| Haematoma | Vascular disorders | MedDRA (10.1) |
|
| Hypertension | Vascular disorders | MedDRA (10.1) |
|
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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 |