Back to resultsSafety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Primary Purpose
Encephalitis
Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
IC51 Japanese Encephalitis
Havrix®720
Prevnar
Sponsored by
About this trial
This is an interventional prevention trial for Encephalitis focused on measuring Pediatric, Japanese Encephalitis Vaccine, endemic countries, to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51
Eligibility Criteria
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.
Sites / Locations
- Research Institute for Tropical Medicine
- Department of Pediatrics, UP-Philippine General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
IC51 0.5 mL
IC51 0.25 mL
Havrix 720
Prevnar
Arm Description
Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
Havrix®720 0.5 ml im. at day 0 and month 7
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Rate of Subjects With Abnormal Laboratory Parameters
Rate of subjects with abnormal laboratory parameters clinically significant results are shown below
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01041573
Brief Title
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
Official Title
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population. Open Label, Randomized, Active Controlled, Phase 3 Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1869 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC51 0.5 mL
Arm Type
Experimental
Arm Description
Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
Arm Title
IC51 0.25 mL
Arm Type
Experimental
Arm Description
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
Arm Title
Havrix 720
Arm Type
Active Comparator
Arm Description
Havrix®720 0.5 ml im. at day 0 and month 7
Arm Title
Prevnar
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
IC51 Japanese Encephalitis
Intervention Description
6 mcg or 3 mcg im. at day 0 and day 28
Intervention Type
Biological
Intervention Name(s)
Havrix®720
Intervention Description
0.5 ml im. at day 0 and month 7
Intervention Type
Biological
Intervention Name(s)
Prevnar
Intervention Description
0.5 ml im. at day 0 and day 56 and month 7
Primary Outcome Measure Information:
Title
Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
Description
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.
Time Frame
until Day 56
Secondary Outcome Measure Information:
Title
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Description
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.
Time Frame
Day 0, 56 and at Month 7
Title
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Description
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.
Time Frame
Days 0, 56 and at Month 7
Title
Rate of Subjects With SAEs and Medically Attended AEs
Description
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.
Time Frame
up to Month 7
Title
Rate of Subjects With Solicited Local and Systemic AEs
Description
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.
Time Frame
7 days post vaccination
Title
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Description
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.
Time Frame
Day 56 and up to Month 7
Title
Rate of Subjects With Abnormal Laboratory Parameters
Description
Rate of subjects with abnormal laboratory parameters clinically significant results are shown below
Time Frame
Day 56 and Month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Kadlecek
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute for Tropical Medicine
City
Muntinlupa
State/Province
Filinvest Corporate City
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Department of Pediatrics, UP-Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
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