Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2014
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 9, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedResults Posted
Study results publicly available
December 7, 2016
CompletedDecember 7, 2016
October 1, 2016
1 month
August 9, 2015
January 12, 2016
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
Day 0 (Baseline) and Day 28 (post-vaccination)
Secondary Outcomes (2)
Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Day 0 (Baseline) and Day 28 (post-vaccination)
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™
Up to 28 days post booster vaccination
Study Arms (1)
Imojev
EXPERIMENTALLive attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Interventions
0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Eligibility Criteria
You may qualify if:
- History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
- Provision of informed consent by the parent(s) or legal guardian(s)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Siriraj Hospitallead
- Sanofi Pasteur, a Sanofi Companycollaborator
Related Publications (1)
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.
PMID: 27846060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof.Kulkanya Chokephaibulkit
- Organization
- Siriraj Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kulkanya Chokephaibulkit, Professor
Siriraj Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2015
First Posted
August 18, 2015
Study Start
June 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
December 7, 2016
Results First Posted
December 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share
The submission of study review and results to a peer-review journal is ongoing.