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Post-licensure Safety Study of IMOJEV® in Thailand

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ClinicalTrials.gov Identifier: NCT01981967
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief 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®.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
Study Start Date : November 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Primary Vaccination Group
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.
 Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Other Name: IMOJEV®
Active Comparator: Booster Vaccination Group
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
 Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
Other Name: IMOJEV®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   9 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981967


Locations
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Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
Khon Kaen, Thailand, 40002
Nakornnayok, Thailand, 26120
Nonthaburi, Thailand, 11120
Pathumthani, Thailand, 12120
Songkla, Thailand, 90110
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01981967    
Other Study ID Numbers: JEC17
U1111-1127-7052 ( Other Identifier: WHO )
First Posted: November 13, 2013    Key Record Dates
Results First Posted: May 4, 2016
Last Update Posted: May 4, 2016
Last Verified: March 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Japanese encephalitis
IMOJEV®
Japanese encephalitis chimeric virus vaccine
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
 Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs