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Completed

NCT Number: NCT01981967

Post-licensure Safety Study of IMOJEV® in Thailand

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®.

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

9 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine

Biological

0.5 mL, Subcutaneous.

Other names: IMOJEV®

Primary outcomes

  1. Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®

    Time frame: 30 minutes post-vaccination up to Day 60 post-vaccination

  2. Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®

    Time frame: Day O up to Day 60 post-vaccination

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®

    Time frame: Day O up to Day 60 post-vaccination

    Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2013
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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