Japanese EncephalitisPhase 3NCT00605085
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
A Phase 3 study testing Japanese Encephalitis purified inactivated vaccine (IC51) in people with Japanese Encephalitis, run by Valneva Austria GmbH.
Trial summary
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control 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?
- Japanese Encephalitis purified inactivated vaccine (IC51)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,675 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Nov 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
- 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
- History of any previous JE vaccination (e.g. JE-VAX®)
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Any acute infections within 2 weeks prior to enrollment
- Known or suspected HIV Infection
- Pregnancy, lactation or unreliable contraception in female subjects
About this study
Official title: Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years
- Conditions
- Japanese Encephalitis
- Being tested
- Japanese Encephalitis purified inactivated vaccine (IC51), Placebo
- 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 vaccine (IC51)Biological
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
PlaceboBiological
Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IC51 Receives: Biological: Japanese Encephalitis purified inactivated vaccine (IC51) |
| 2 | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability up to Day 56
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Measured: Day 56
Secondary outcomes (3)
Rates of Serious Adverse Events and Medically Attended Adverse Events
Measured: until Day 56
Changes in Laboratory Parameters
Measured: until Day 56
SCR and GMT of Subjects With Concomitant Vaccinations
Measured: until 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 startOct 2005
- Study completionNov 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Astrid Kaltenboeck, Ph.D., Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605085
- Sponsor's protocol ID
- IC51-302
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2008
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
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
- Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study
- ClinicalTrials.gov ID
- NCT00605085
- Acronym / sponsor ID
- IC51-302
- Conditions
- Japanese Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,675 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 30 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 investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Japanese Encephalitis purified inactivated vaccine (IC51)IC51 |
| 2 | Placebo comparator | Biological: PlaceboPlacebo |
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 (8 listed)
- 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
- History of any previous JE vaccination (e.g. JE-VAX®)
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
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 vaccine (IC51)IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28 | Biological | 1 |
| PlaceboPlacebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28 | Biological | 2 |
Primary outcome
Safety and Tolerability up to Day 56
Time frame: Day 56
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
3 secondary outcomes
Rates of Serious Adverse Events and Medically Attended Adverse Events
Time frame: until Day 56
Changes in Laboratory Parameters
Time frame: until Day 56
SCR and GMT of Subjects With Concomitant Vaccinations
Time frame: until 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 Japanese Encephalitis purified inactivated vaccine (IC51) 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 8 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. Some participants in this study may receive a placebo. 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?
Safety and Tolerability up to Day 56 (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 21 Mar 2024.