Post-licensure Safety Study of IMOJEV® in Thailand

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01981967
First received: November 5, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Japanese Encephalitis
Biological: IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    An SAE is defined as any untoward medical occurrence that at any dose (including overdose), that: Results in death; Is life threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect, or Is an important medical event


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Grade 3 AE defined as: Fever, body temperature >39.5°C for subjects aged ≤ 23 months or ≥ 39.0°C for subjects aged ≥ 2 years; for any other AEs, significant AE that prevents normal activity


Estimated Enrollment: 10000
Study Start Date: November 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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

Ages Eligible for Study:   1 Year to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children requiring vaccination against Japanese encephalitis
  • Children aged 1 year 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981967

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

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

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01981967     History of Changes
Other Study ID Numbers: JEC17, U1111-1127-7052
Study First Received: November 5, 2013
Last Updated: May 6, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Japanese encephalitis
IMOJEV®
Japanese encephalitis chimeric virus vaccine

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014