Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
1 other identifier
interventional
1,869
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2010
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 31, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
February 27, 2014
CompletedJuly 27, 2021
July 1, 2021
11 months
December 30, 2009
January 16, 2014
July 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
until Day 56
Secondary Outcomes (6)
Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies
Day 0, 56 and at Month 7
Seroconversion Rate (SCR) at Days 0, 56 and at Month 7
Days 0, 56 and at Month 7
Rate of Subjects With SAEs and Medically Attended AEs
up to Month 7
Rate of Subjects With Solicited Local and Systemic AEs
7 days post vaccination
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Day 56 and up to Month 7
- +1 more secondary outcomes
Study Arms (4)
IC51 0.5 mL
EXPERIMENTALJapanese Encephalitis Vaccine 6mcg im. at day 0 and day 28
IC51 0.25 mL
EXPERIMENTALJapanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
Havrix 720
ACTIVE COMPARATORHavrix®720 0.5 ml im. at day 0 and month 7
Prevnar
ACTIVE COMPARATORPrevnar 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Research Institute for Tropical Medicine
City of Muntinlupa, Filinvest Corporate City, 1781, Philippines
Department of Pediatrics, UP-Philippine General Hospital
Manila, 1000, Philippines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager Clinical Research
- Organization
- Valneva Austria GmbH
Study Officials
- STUDY DIRECTOR
Vera Kadlecek
Valneva Austria GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2009
First Posted
December 31, 2009
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
July 1, 2011
Last Updated
July 27, 2021
Results First Posted
February 27, 2014
Record last verified: 2021-07