Overview

This trial is active, not recruiting.

Condition encephalitis
Treatments ic51
Phase phase 3
Sponsor Valneva Austria GmbH
Start date January 2010
End date August 2013
Trial size 100 participants
Trial identifier NCT01047839, IC51-322

Summary

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
ic51
0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
(Experimental)
IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
ic51
0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
(Experimental)
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
ic51
0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Primary Outcomes

Measure
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination
time frame: until Day 56

Secondary Outcomes

Measure
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Month 7 after the first vaccination
time frame: up to Month 7
Rate of subjects with solicited local and systemic aEs assessed with a subject diary for 7 consecutive days after each vaccination
time frame: 7 days
Rate of subjects with unsolicited AEs up to day 56 and up to Month 7 after the first vaccination
time frame: up to Day 56 and upt to Month 7
Rate of subjects with abnormal laboratory parameters up to Day 56 and up to Month 7 after the first vaccination
time frame: up to Day 56 and up to Month 7
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)
time frame: at Day 56 and Month 7
GMTs for JEV neutralizing antibodies measured using a validated PRNT at Day 56 and Month 7
time frame: at Day 56 and Month 7
SCRs and GMTs at Day 56 and Month 7 stratified according to dose gropus and age groups
time frame: at Day 56 and Month 7

Eligibility Criteria

Male or female participants from 2 months up to 17 years old.

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.

Additional Information

Official title Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Valneva Austria GmbH.