- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041573
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Manila, Philippines, 1000
- Department of Pediatrics, UP-Philippine General Hospital
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Filinvest Corporate City
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Muntinlupa, Filinvest Corporate City, Philippines, 1781
- Research Institute for Tropical Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IC51 0.5 mL
Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
|
6 mcg or 3 mcg im. at day 0 and day 28
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Experimental: IC51 0.25 mL
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
|
6 mcg or 3 mcg im. at day 0 and day 28
|
Active Comparator: Havrix 720
Havrix®720 0.5 ml im. at day 0 and month 7
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0.5 ml im. at day 0 and month 7
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Active Comparator: Prevnar
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
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0.5 ml im. at day 0 and day 56 and month 7
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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until Day 56
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Time Frame: Day 0, 56 and at Month 7
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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.
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Day 0, 56 and at Month 7
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Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Time Frame: Days 0, 56 and at Month 7
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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.
|
Days 0, 56 and at Month 7
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Rate of Subjects With SAEs and Medically Attended AEs
Time Frame: up to Month 7
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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.
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up to Month 7
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Rate of Subjects With Solicited Local and Systemic AEs
Time Frame: 7 days post vaccination
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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. |
7 days post vaccination
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Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Time Frame: Day 56 and up to Month 7
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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.
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Day 56 and up to Month 7
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Rate of Subjects With Abnormal Laboratory Parameters
Time Frame: Day 56 and Month 7
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Rate of subjects with abnormal laboratory parameters clinically significant results are shown below
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Day 56 and Month 7
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vera Kadlecek, Valneva Austria GmbH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
- Physiological Effects of Drugs
- Immunologic Factors
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- IC51-323
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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