Post-licensure Safety Study of IMOJEV® in Thailand

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01981967
• Other study ID #: JEC17
• Secondary ID: U1111-1127-7052
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 5, 2013
• Last updated: August 17, 2015
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: June 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 4 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.
• IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and nature of Serious Adverse Events (including Adverse Events of Special Interests) reported following a primary or booster vaccination with IMOJEV® vaccine	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	Day 0 up to Day 60 post-vaccination	No
Secondary	Number and nature of Grade 3 systemic AEs reported after vaccination following a primary or booster vaccination with IMOJEV® vaccine	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	30 minutes post-vaccination	No

External Links

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