Phase 3
N=100
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01047839 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Dec 2014
Primary outcome: Primary: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination — 33.3; 20.7; 3.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IC51 (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination |
33.3; 20.7; 3.4 | — |
| SECONDARY Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination |
0; 3.4; 33.3; 18.2 | — |
| SECONDARY Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination |
28.6; 48.9; 33.3; 46.0; 22.2; 29.4 | — |
| SECONDARY Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination |
83.3; 29.5; 91.7; 43.2 | — |
| SECONDARY Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination |
1; 0; 0; 1 | — |
| SECONDARY SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT) |
100.0; 100.0; 100.0; 90.6 | — |
| SECONDARY GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7 |
216.18; 340.74; 47.96; 57.12 | — |
| SECONDARY SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups |
100; 100.0; 100.0; 100.0; 66.7; 93.1 | — |
| SECONDARY GMTs at Day 56 and Month 7 Stratified According to Age Groups |
216.18; 508.03; 295.44; 47.96; 31.96; 60.65 | — |
Summary
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
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.
- The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.
Exclusion Criteria
- Clinical manifestation or history of any Flavivirus disease
- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
- 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 1 week before and 1 week after each IC51 vaccination.
Data sourced from ClinicalTrials.gov (NCT01047839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.