Japanese EncephalitisNCT01335412
Safety Surveillance After Immunization With IXIARO
An observational study of Japanese Encephalitis, run by Valneva Austria GmbH at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Japanese Encephalitis Virus vaccine, inactivated, adsorbed
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
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.
- Conditions
- Japanese Encephalitis
- Being tested
- Japanese Encephalitis Virus vaccine, inactivated, adsorbed
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese Encephalitis Virus vaccine, inactivated, adsorbedBiological
Also called IXIARO
2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbed | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pre-defined, serious adverse events
Measured: 42 days after each dose of IXIARO
Secondary outcomes (3)
Detection of non-predefined Adverse Events overrepresented after IXIARO
Data-mining for overrepresented Adverse events in the IXIARO exposed group compared to comparison group
Measured: 42 days after each dose of IXIARO
Occurrence of complications during pregnancy
Detect and describe pregnancy complications following inadvertent vaccination in pregnant women
Measured: Up to delivery
Occurrance of infant health complications
Detect and describe infant health complications following inadvertent vaccination in pregnant women
Measured: up to 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katrin L Dubischar-Kastner, MSc, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335412
- Sponsor's protocol ID
- IC51-401
- Status last verified
- Mar 2015
- First submitted
- 13 Apr 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
- ClinicalTrials.gov ID
- NCT01335412
- Acronym / sponsor ID
- IC51-401
- Conditions
- Japanese Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IXIARO exposed group | – | Biological: Japanese Encephalitis Virus vaccine, inactivated, adsorbedMale 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 |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Japanese Encephalitis Virus vaccine, inactivated, adsorbedAlso: IXIARO2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster) | Biological | IXIARO exposed group |
Primary outcome
Incidence of pre-defined, serious adverse events
Time frame: 42 days after each dose of IXIARO
3 secondary outcomes
Detection of non-predefined Adverse Events overrepresented after IXIARO
Time frame: 42 days after each dose of IXIARO
Occurrence of complications during pregnancy
Time frame: Up to delivery
Occurrance of infant health complications
Time frame: up to 3 months after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin L Dubischar-Kastner, MSc study director
Valneva Austria GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Japanese Encephalitis, run by Valneva Austria GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pre-defined, serious adverse events (time frame: 42 days after each dose of IXIARO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.