Overview

This trial is active, not recruiting.

Condition japanese encephalitis
Treatments imojev®: live attenuated japanese encephalitis chimeric virus vaccine
Phase phase 4
Sponsor Sanofi Pasteur, a Sanofi Company
Start date November 2013
End date April 2015
Trial size 10000 participants
Trial identifier NCT01981967, JEC17, U1111-1127-7052

Summary

The aim of this study is to further characterize the safety profile of IMOJEV®.

Primary Objective:

- To describe serious adverse events (SAEs, including adverse events of special interest [AESIs]) up to 60 days after administration of one dose of IMOJEV®.

Secondary Objective:

- To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants who never received a JE vaccine, or who received a single dose of inactivated JE vaccine, or whose JE vaccination history is unknown or not documented.
imojev®: live attenuated japanese encephalitis chimeric virus vaccine IMOJEV®
0.5 mL, Subcutaneous.
(Active Comparator)
Participants who received at least 2 doses of inactivated JE vaccine (at least 1 year earlier for the last dose), or received a single dose of IMOJEV®, THAIJEV®, or IMOJEV® MD as part of the routine vaccination schedule (i.e., outside of Study JEC17) at least 1 year earlier
imojev®: live attenuated japanese encephalitis chimeric virus vaccine IMOJEV®
0.5 mL, Subcutaneous.

Primary Outcomes

Measure
Number and nature of Serious Adverse Events (including Adverse Events of Special Interests) reported following a primary or booster vaccination with IMOJEV® vaccine
time frame: Day 0 up to Day 60 post-vaccination

Secondary Outcomes

Measure
Number and nature of Grade 3 systemic AEs reported after vaccination following a primary or booster vaccination with IMOJEV® vaccine
time frame: 30 minutes post-vaccination

Eligibility Criteria

Male or female participants from 9 months up to 4 years old.

Inclusion Criteria: - Children requiring vaccination against Japanese encephalitis - Children aged 9 months to less than 5 years on the day of inclusion - In good general health at the time of inclusion - Informed consent form has been signed and dated by the parent(s)/legal guardian(s) - Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any additional visits that may need to be done in case of an SAE (including AESI), and are able to comply with all trial procedures - The subject's parent(s)/legal guardian(s) have a telephone number at which they can be contacted throughout the study Exclusion Criteria: - Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the vaccination - Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination - Planned participation in another clinical trial during the present trial period - Children previously vaccinated with the live attenuated Japanese encephalitis vaccine CD-JEVAX® (SA14-14-2 LAV) - Contraindications to vaccination according to the IMOJEV® Summary of Product Characteristics (SmPC) - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study - Children who received IMOJEV® as primary vaccination in this study.

Additional Information

Official title Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
Description Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Sanofi.