Japanese EncephalitisPhase 3NCT00596271
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
A Phase 3 study testing IC51 and HAVRIX in people with Japanese Encephalitis, run by Valneva Austria GmbH.
Trial summary
The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440 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 HAVRIX
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Aug 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
Who may be able to join
- At least 18 years of age
- In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
- 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)
- History of any previous Hepatitis A vaccination and infection
- 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
- Planned administration of another vaccine during the study period
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
Show all 11Show fewer
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- Any acute infections within 4 weeks prior to enrollment
- Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
About this study
Official title: Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-blind Randomized, Controlled Phase 3 Study
The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
Read the detailed description
This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
192 subjects will be enrolled at 2 sites in Europe.
- Conditions
- Japanese Encephalitis
- Being tested
- IC51, HAVRIX, 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.
IC51Biological
Also called Japanese Encephalitis purified inactivated vaccine
HAVRIXBiological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| IC51 and Placebo | Active comparator | 6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) Receives: Biological: IC51; Other: Placebo |
| HAVRIX and placebo | Active comparator | HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) Receives: Biological: HAVRIX; Other: Placebo |
| IC51 and HAVRIX | Active comparator | IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) Receives: Biological: IC51; Biological: HAVRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
Measured: Day 56
GMT for Hepatitis A Virus (HAV) Antibody at Day 28
Measured: Day 28
Secondary outcomes (3)
Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
Measured: day 28 and 56
GMT and SCR for PRNT at Day 28 and HAV at Day 56
Measured: day 28 and 56
Safety
Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)
Measured: until 6 month after last vaccination
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 startSep 2005
- Primary completionJul 2006
- Study completionAug 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 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
- NCT00596271
- Sponsor's protocol ID
- IC51-308
- Status last verified
- Apr 2014
- First submitted
- 4 Jan 2008
- Last updated
- 13 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 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-blind Randomized, Controlled Phase 3 Study
- ClinicalTrials.gov ID
- NCT00596271
- Acronym / sponsor ID
- IC51-308
- Conditions
- Japanese Encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 13 May 2014
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 immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440
Detailed description
This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.
192 subjects will be enrolled at 2 sites in Europe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IC51 and Placebo | Active comparator | Biological: IC51, Other: Placebo6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) |
| HAVRIX and placebo | Active comparator | Biological: HAVRIX, Other: PlaceboHAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) |
| IC51 and HAVRIX | Active comparator | Biological: IC51, Biological: HAVRIXIC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
- Written informed consent obtained prior to study entry
Key exclusion criteria (11 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)
- History of any previous Hepatitis A vaccination and infection
- 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
- Planned administration of another vaccine during the study period
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 vaccine | Biological | IC51 and HAVRIX, IC51 and Placebo |
| HAVRIX | Biological | HAVRIX and placebo, IC51 and HAVRIX |
| Placebo | Other | HAVRIX and placebo, IC51 and Placebo |
Primary outcome
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
Time frame: Day 56
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
GMT for Hepatitis A Virus (HAV) Antibody at Day 28
Time frame: Day 28
3 secondary outcomes
Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
Time frame: day 28 and 56
GMT and SCR for PRNT at Day 28 and HAV at Day 56
Time frame: day 28 and 56
Safety
Time frame: until 6 month after last vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
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 HAVRIX 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 3 inclusion and 11 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 13 May 2014. 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 13 May 2014). 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) at Day 56 for Anti-JEV Neutralizing Antibodies (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 13 May 2014.