Clinical trial NCT02526550: Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Official title: Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Encephalitis
Keywords: Live attenuated Japanese Encephalitis vaccine
IMOJEV
CD.JEVAX
Booster
Thai children
Immunogenicity
Safety
Interchangeability
Hepatitis A vaccine
Vaccination or Other Immunization Procedure
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2015-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

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

Primary outcomes:
measure: Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
timeFrame: Day 0 (Baseline) and Day 28 (post-vaccination)
Secondary outcomes:
measure: Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
timeFrame: Day 0 (Baseline) and Day 28 (post-vaccination)
measure: 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™
timeFrame: Up to 28 days post booster vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Siriraj Hospital
name: Kulkanya Chokephaibulkit, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sricharoenchai S, Lapphra K, Chuenkitmongkol S, Phongsamart W, Bouckenooghe A, Wittawatmongkol O, Rungmaitree S, Chokephaibulkit K. Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine as a Booster Dose After Primary Vaccination With Live Attenuated SA14-14-2 Vaccine: A Phase IV Study in Thai Children. Pediatr Infect Dis J. 2017 Feb;36(2):e45-e47. doi: 10.1097/INF.0000000000001395.