Post-licensure Safety Study of IMOJEV® in Thailand

Sanofi

Status and phase: Completed; Phase 4

Conditions: Japanese Encephalitis

Treatments: Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01981967

U1111-1127-7052 (Other Identifier)

JEC17

Details and patient eligibility

About

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®.

Full 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.

Enrollment: 10,000 patients

Sex: All

Ages: 9 months to 4 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 2 patient groups

Primary Vaccination Group

Experimental group

Description:

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.

Treatment:

Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Booster Vaccination Group

Active Comparator group

Description:

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

Treatment:

Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine