Japanese EncephalitisPhase 3NCT00604708
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
A Phase 3 study testing IC51 and JE-VAX in people with Japanese Encephalitis, run by Valneva Austria GmbH.
Trial summary
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years 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?
- IC51 and JE-VAX
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 867 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Sep 2006
- 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
Who may be able to join
- At least 18 years of age
- Written informed consent obtained prior to study entry
Who cannot join
- History of clinical manifestation of any flavivirus infection
- History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
Show all 9Show fewer
- Any acute infections within 4 weeks prior to enrollment
- Infection with HIV, Hepatitis B or Hepatitis C
- Pregnancy, lactation or unreliable contraception in female subjects
About this study
Official title: Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years
- Conditions
- Japanese Encephalitis
- Being tested
- IC51, JE-VAX
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC51Biological
Also called Japanese Encephalitis purified inactivated vaccine
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
JE-VAXBiological
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28
| Study group | Role | What they receive |
|---|---|---|
| IC51 | Experimental | 6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28 Receives: Biological: IC51 |
| JE-VAX | Active comparator | given s.c. on Day 0, 7 and 28 Receives: Biological: JE-VAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
SCR: anti-JEV neutralizing antibody titer ≥1:10
Measured: Day 56
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
GMT: geometric mean of PRNT50
Measured: Day 56
Secondary outcomes (4)
Safety and Adverse Events
Measured: until Day 56
Immunogenicity at Day 28
Measured: Day 28
Immunogenicity at Day 56 for North America vs. Europe
Measured: Day 56
Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
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 posted30 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2006
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astrid Kaltenboeck, Ph.D., Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604708
- Sponsor's protocol ID
- IC51-301
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2008
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00604708
- Acronym / sponsor ID
- IC51-301
- Conditions
- Japanese Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 29 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 the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC51 | Experimental | Biological: IC516 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28 |
| JE-VAX | Active comparator | Biological: JE-VAXgiven s.c. on Day 0, 7 and 28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Written informed consent obtained prior to study entry
Key exclusion criteria (9 listed)
- History of clinical manifestation of any flavivirus infection
- History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
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 |
|---|---|---|
| IC51Also: Japanese Encephalitis purified inactivated vaccineIC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28 | Biological | IC51 |
| JE-VAXJE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28 | Biological | JE-VAX |
Primary outcome
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Time frame: Day 56
SCR: anti-JEV neutralizing antibody titer ≥1:10
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
Time frame: Day 56
GMT: geometric mean of PRNT50
4 secondary outcomes
Safety and Adverse Events
Time frame: until Day 56
Immunogenicity at Day 28
Time frame: Day 28
Immunogenicity at Day 56 for North America vs. Europe
Time frame: Day 56
Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
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 21 Mar 2024.
- 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.
Astrid Kaltenboeck, Ph.D. study director
Valneva Austria GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IC51 and JE-VAX in people with Japanese Encephalitis, run by Valneva Austria GmbH.
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 2 inclusion and 9 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 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 29 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?
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 (time frame: Day 56). The study lists 2 primary outcomes in all. 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 21 Mar 2024.