EncephalitisPhase 3NCT01041573
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
A Phase 3 study testing IC51 Japanese Encephalitis, Havrix®720 and Prevnar in people with Encephalitis, run by Valneva Austria GmbH at 2 sites in Philippines.
Trial summary
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions. Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis
- What is being tested?
- IC51 Japanese Encephalitis, Havrix®720 and Prevnar
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,869 participants
- Where
- 2 sitesPhilippines
- Study dates
- Mar 2010to Jul 2011
- 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 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female healthy children and adolescents aged > 2 months to < 18 years at the time of first vaccination.
- Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
- Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.
Who cannot join
- Clinical manifestation of Japanese Encephalitis
- History of Flavivirus vaccination (including any investigational vaccines)
- History of vaccination with HAVRIX®720 and/or Prevnar®
- History of immunodeficiency or immunosuppressive therapy
- Known HIV, HBV or HCV infection
- History of hypersensitivity reactions to other vaccines
- Acute febrile infection at each visit during which the subject receives a vaccination
- Active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Research Institute for Tropical Medicine
City of Muntinlupa, Filinvest Corporate City, 1781
Department of Pediatrics, UP-Philippine General Hospital
Manila, 1000
About this study
Official title: Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Read the detailed description
Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to < 18 years. Subjects aged ≥ 2 months to < 12 months were randomized in a 2:1 ratio to receive IC51 (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to < 3 years and ≥ 12 years to < 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose < 3 years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator.
For subjects aged ≥ 3 years to < 12 years, a dose finding run-in phase was performed. A total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51, and the appropriate dose was determined based on an interim analysis. After this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of IC51 or HAVRIX®720.
Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to < 12 months; 125 children aged ≥ 12 months to < 3 years and 140 children ≥ 12 years to < 18 years. For the age group of ≥ 3 to < 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.
- Conditions
- Encephalitis
- Being tested
- IC51 Japanese Encephalitis, Havrix®720, Prevnar
- Keywords
- Pediatric, Japanese Encephalitis Vaccine, endemic countries, to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51
- Medical subject headings
- Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC51 Japanese EncephalitisBiological
6 mcg or 3 mcg im. at day 0 and day 28
Havrix®720Biological
0.5 ml im. at day 0 and month 7
PrevnarBiological
0.5 ml im. at day 0 and day 56 and month 7
| Study group | Role | What they receive |
|---|---|---|
| IC51 0.5 mL | Experimental | Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28 Receives: Biological: IC51 Japanese Encephalitis |
| IC51 0.25 mL | Experimental | Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28 Receives: Biological: IC51 Japanese Encephalitis |
| Havrix 720 | Active comparator | Havrix®720 0.5 ml im. at day 0 and month 7 Receives: Biological: Havrix®720 |
| Prevnar | Active comparator | Prevnar 0.5 ml im. at day 0 and day 56 and month 7 or 0.5 ml im. at day 0, day 28 and day56 and month 7-13 Receives: Biological: Prevnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged < 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
Measured: until Day 56
Secondary outcomes (6)
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
GMT for JEV neutralizing antibodies is presented per dose group rather than age group due to overlapping age groups. IC51 0.25 mL includes subjects aged 2 months to < 12 years; IC51 0.5 mL includes subjects aged ≥ 3 years to < 18 years.
Measured: Day 0, 56 and at Month 7
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Seroconversion was defined as a PRNT50 titer of at least 1:10. SCRs are presented per dose group rather than age group due to overlapping age groups. IC51 0.25 mL includes subjects aged 2 months to < 12 years; IC51 0.5 mL includes subjects aged ≥ 3 years to < 18 years.
Measured: Days 0, 56 and at Month 7
Rate of Subjects With SAEs and Medically Attended AEs
Rate of subjects with SAEs and medically attended AEs; For this analysis IC51 vaccine recipients are displayed by age group rather than by dose group. This allows comparison of the safety profile of IC51 with the active control for the respective age group: Prevnar for study participants aged >= 2 months to <1 year and Havrix 720 for study participants aged >= 1 year.
Measured: up to Month 7
Rate of Subjects With Solicited Local and Systemic AEs
Rate of subjects with solicited local and systemic AEs. Solicited AEs of local and systemic tolerability, i.e., reactions at the injection site or systemic reactions typical for vaccinations, were to be evaluated for 7 consecutive days after each vaccination (except after the HAVRIX®750 and Prevnar® injections at Month 7 [Visit 4]) and recorded in the subject diary.
For this analysis IC51 vaccine recipients are displayed by age group rather than by dose group. This allows comparison of the safety profile of IC51 with the active control for the respective age group: Prevnar for study participants aged >= 2 months to <1 year and Havrix 720 for study participants aged >= 1 year.
Measured: 7 days post vaccination
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7; For this analysis IC51 vaccine recipients are displayed by age group rather than by dose group. This allows comparison of the safety profile of IC51 with the active control for the respective age group: Prevnar for study participants aged >= 2 months to <1 year and Havrix 720 for study participants aged >= 1 year.
Measured: Day 56 and up to Month 7
Rate of Subjects With Abnormal Laboratory Parameters
Rate of subjects with abnormal laboratory parameters clinically significant results are shown below
Measured: Day 56 and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionJul 2011
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 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
- None (open label)
- Enrolment
- 1,869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vera Kadlecek, Study director, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041573
- Sponsor's protocol ID
- IC51-323
- Status last verified
- Jul 2021
- First submitted
- 30 Dec 2009
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
- ClinicalTrials.gov ID
- NCT01041573
- Acronym / sponsor ID
- IC51-323
- Conditions
- Encephalitis
- Keywords
- Pediatric, Japanese Encephalitis Vaccine, endemic countries, to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,869 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 31 Dec 2009 (estimated)
- Results
- Posted 27 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.
Detailed description
Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to < 18 years. Subjects aged ≥ 2 months to < 12 months were randomized in a 2:1 ratio to receive IC51 (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to < 3 years and ≥ 12 years to < 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose < 3 years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator.
For subjects aged ≥ 3 years to < 12 years, a dose finding run-in phase was performed. A total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51, and the appropriate dose was determined based on an interim analysis. After this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of IC51 or HAVRIX®720.
Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to < 12 months; 125 children aged ≥ 12 months to < 3 years and 140 children ≥ 12 years to < 18 years. For the age group of ≥ 3 to < 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IC51 0.5 mL | Experimental | Biological: IC51 Japanese EncephalitisJapanese Encephalitis Vaccine 6mcg im. at day 0 and day 28 |
| IC51 0.25 mL | Experimental | Biological: IC51 Japanese EncephalitisJapanese Encephalitis Vaccine 3mcg im. at day 0 and day 28 |
| Havrix 720 | Active comparator | Biological: Havrix®720Havrix®720 0.5 ml im. at day 0 and month 7 |
| Prevnar | Active comparator | Biological: PrevnarPrevnar 0.5 ml im. at day 0 and day 56 and month 7 or 0.5 ml im. at day 0, day 28 and day56 and month 7-13 |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female healthy children and adolescents aged > 2 months to < 18 years at the time of first vaccination.
- Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
- Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.
Key exclusion criteria (8 listed)
- Clinical manifestation of Japanese Encephalitis
- History of Flavivirus vaccination (including any investigational vaccines)
- History of vaccination with HAVRIX®720 and/or Prevnar®
- History of immunodeficiency or immunosuppressive therapy
- Known HIV, HBV or HCV infection
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 |
|---|---|---|
| IC51 Japanese Encephalitis6 mcg or 3 mcg im. at day 0 and day 28 | Biological | IC51 0.25 mL, IC51 0.5 mL |
| Havrix®7200.5 ml im. at day 0 and month 7 | Biological | Havrix 720 |
| Prevnar0.5 ml im. at day 0 and day 56 and month 7 | Biological | Prevnar |
Primary outcome
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
Time frame: until Day 56
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged < 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
6 secondary outcomes
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Time frame: Day 0, 56 and at Month 7
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Time frame: Days 0, 56 and at Month 7
Rate of Subjects With SAEs and Medically Attended AEs
Time frame: up to Month 7
Rate of Subjects With Solicited Local and Systemic AEs
Time frame: 7 days post vaccination
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Time frame: Day 56 and up to Month 7
Rate of Subjects With Abnormal Laboratory Parameters
Time frame: Day 56 and Month 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- 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.
Vera Kadlecek study director
Valneva Austria GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IC51 Japanese Encephalitis, Havrix®720 and Prevnar in people with Encephalitis, run by Valneva Austria GmbH at 2 sites in Philippines.
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 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. 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 27 Feb 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?
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination (time frame: until 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 27 Jul 2021.