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This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered.
There will be no intervention and no individuals contacted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IXIARO exposed group | Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO |
| |
| Comparison group | Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of JE-VAX |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese Encephalitis Virus vaccine, inactivated, adsorbed | Biological | 2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pre-defined, serious adverse events | 42 days after each dose of IXIARO |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of non-predefined Adverse Events overrepresented after IXIARO | Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group | 42 days after each dose of IXIARO |
| Occurrence of complications during pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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Active duty military personnel (Army, Navy, Air Force, and Marines) who are ≥17 years of age and received at least one dose of Japanese encephalitis vaccine.
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| Name | Affiliation | Role |
|---|---|---|
| Katrin L Dubischar-Kastner, MSc | Valneva Austria GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Vaccine Agency | Alexandria | Virginia | 22312 | United States |
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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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|
Detect and describe pregnancy complications following inadvertent vaccination in pregnant women |
| Up to delivery |
| Occurrance of infant health complications | Detect and describe infant health complications following inadvertent vaccination in pregnant women | up to 3 months after birth |
| 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 |