Japanese EncephalitisPhase 3NCT00595465
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
A Phase 3 study testing Japanese Encephalitis purified inactivated vaccine in people with Japanese Encephalitis, run by Valneva Austria GmbH at 4 sites in 2 countries.
Trial summary
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Japanese Encephalitis purified inactivated vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2007to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test
Main Exclusion Criteria:
- History of immunodeficiency or immunosuppressive therapy,
- Known Human Immunodeficiency Virus (HIV); OR
- Drug addiction including alcohol dependence
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Berliner Zentrum Reise- und Tropenmedizin
Berlin, 10117
Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
Munich, 80802
Klinik und Poliklinik für Innere Medizin der Universität Rostock
Rostock, 18057
Austria1 site
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Vienna, 1090
About this study
Official title: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
- Conditions
- Japanese Encephalitis
- Being tested
- Japanese Encephalitis purified inactivated vaccine
- 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 purified inactivated vaccineBiological
IC51 6 mcg i.m. injection on Day 0 and Day 28
| Study group | Role | What they receive |
|---|---|---|
| IC51 Batch A | Active comparator | Not described Receives: Biological: Japanese Encephalitis purified inactivated vaccine |
| IC51 Batch B | Active comparator | Not described Receives: Biological: Japanese Encephalitis purified inactivated vaccine |
| IC51 Batch C | Active comparator | Not described Receives: Biological: Japanese Encephalitis purified inactivated vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Measured: Day 56
Secondary outcomes (2)
Seroconversion Rate
Measured: Day 56
Safety and Adverse Events
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Haas, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595465
- Sponsor's protocol ID
- IC51-310
- Status last verified
- May 2014
- First submitted
- 4 Jan 2008
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
- ClinicalTrials.gov ID
- NCT00595465
- Acronym / sponsor ID
- IC51-310
- Conditions
- Japanese Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 20 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IC51 Batch A | Active comparator | Biological: Japanese Encephalitis purified inactivated vaccine |
| IC51 Batch B | Active comparator | Biological: Japanese Encephalitis purified inactivated vaccine |
| IC51 Batch C | Active comparator | Biological: Japanese Encephalitis purified inactivated vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 purified inactivated vaccineIC51 6 mcg i.m. injection on Day 0 and Day 28 | Biological | IC51 Batch A, IC51 Batch B, IC51 Batch C |
Primary outcome
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Time frame: Day 56
2 secondary outcomes
Seroconversion Rate
Time frame: Day 56
Safety and Adverse Events
Time frame: Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicole Haas study director
Valneva Austria GmbH
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Japanese Encephalitis purified inactivated vaccine in people with Japanese Encephalitis, run by Valneva Austria GmbH at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody (time frame: Day 56). 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 16 May 2014.