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COMPLETEDPHASE4

Post-licensure Safety Study of IMOJEV® in Thailand

Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand

NCT01981967•Sanofi Pasteur, a Sanofi Company

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®.

Detailed 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.

Eligibility

Age

0 - 4 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (8)

Bangkok, Thailand

Chiang Mai, Thailand

Khon Kaen, Thailand

Nakornnayok, Thailand

Nonthaburi, Thailand

Pathum Thani, Thailand

Songkhla, Thailand

Key Dates

Start Date

November 1, 2013

Primary Completion Date

April 1, 2015

Completion Date

October 1, 2015

Last Updated

May 4, 2016

Enrollment

10,000

ACTUAL participants

Conditions

Japanese Encephalitis

Interventions

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

BIOLOGICAL

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

BIOLOGICAL

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

NCT06372665

Japanese Encephalitis

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COMPLETEDPHASE3

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

NCT00594958

Japanese Encephalitis

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UNKNOWNPHASE4

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Post-licensure Safety Study of IMOJEV® in Thailand

Inclusion Criteria

Exclusion Criteria

Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51

Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province

Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age

Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines