Safety Surveillance After Immunization With IXIARO
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Intercell AG.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Intercell AG
Information provided by:
Intercell AG
ClinicalTrials.gov Identifier:
NCT01335412
First received: April 13, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Japanese Encephalitis |
Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel |
Resource links provided by NLM:
Further study details as provided by Intercell AG:
Primary Outcome Measures:
- Incidence of pre-defined, serious adverse events [ Time Frame: 42 days after each dose of IXIARO ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Detection of non-predefined Adverse Events overrepresented after IXIARO [ Time Frame: 42 days after each dose of IXIARO ] [ Designated as safety issue: Yes ]Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group
- Occurrence of complications during pregnancy [ Time Frame: Up to delivery ] [ Designated as safety issue: Yes ]Detect and describe pregnancy complications following inadvertent vaccination in pregnant women
- Occurrance of infant health complications [ Time Frame: up to 3 months after birth ] [ Designated as safety issue: Yes ]Detect and describe infant health complications following inadvertent vaccination in pregnant women
| Estimated Enrollment: | 20000 |
| Study Start Date: | March 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed
2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)
Other Name: 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
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO (IXIARO exposed group) or at least one dose of JE-VAX (comparison group).
Exclusion Criteria:
- Individuals who have an ICD-9-CM code suggestive of one of the predefined adverse events screened for in IC51-401 prior to vaccination with IXIARO cannot with certainty be classified as being "disease free" at study entry and will be excluded for that adverse event.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335412
Contacts
| Contact: Katrin L Dubischar-Kastner, MSc | +43 1 20620 ext 1175 | kdubischar-kastner@intercell.at |
Locations
| United States, Virginia | |
| Military Vaccine Agency | Recruiting |
| Alexandria, Virginia, United States, 22312 | |
Sponsors and Collaborators
Intercell AG
Investigators
| Study Director: | Katrin L Dubischar-Kastner, MSc | Intercell AG |
More Information
No publications provided
| Responsible Party: | Katrin Dubischar-Kastner, Senior Manager Clinical Research, Intercell AG |
| ClinicalTrials.gov Identifier: | NCT01335412 History of Changes |
| Other Study ID Numbers: | IC51-401 |
| Study First Received: | April 13, 2011 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Japanese Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Encephalitis, Arbovirus Arbovirus Infections Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 21, 2013