Phase 4
N=10,000
Post-licensure Safety Study of IMOJEV® in Thailand
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01981967 ↗Enrolled (actual)
10,000
Serious AEs
2.6%
Results posted
May 2016
Primary outcome: Primary: Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® — 0; 0; 204; 59 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV® |
0; 0; 204; 59; 0; 1 | — |
| PRIMARY Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV® |
43; 0; 155; 0; 6; 59 | — |
| SECONDARY Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV® |
25; 2; 1; 0; 1; 0 | — |
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®.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01981967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.