Phase 4
N=50
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT02526550 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination — 9144 titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Live attenuated chimeric Japanese Encephalitis vaccine (Biological); Inactivated Hepatitis A vaccine (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Siriraj Hospital
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination |
9144 | — |
| SECONDARY Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination |
100 | — |
| SECONDARY Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™ |
0; 10.2; 6.1; 6.1; 10.3; 8.3 | — |
Summary
This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.
Eligibility Criteria
Inclusion Criteria
- Children aged 1 to <5 years on the day of inclusion
- History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
- In good general health at the time of inclusion
- Provision of informed consent by the parent(s) or legal guardian(s)
Exclusion Criteria
- Receipt of blood or blood products in the past 3 months
- Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
- Previous receipt of 2 doses of any vaccine against JE virus
- Known hypersensitivity to any of the vaccine components
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
Data sourced from ClinicalTrials.gov (NCT02526550). 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.