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Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

NCT02526550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-12-07

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Live 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

BIOLOGICAL

Inactivated Hepatitis A vaccine

0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Siriraj Hospital

    lead OTHER

Principal Investigators

  • Kulkanya Chokephaibulkit, Professor · Siriraj Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526550 on ClinicalTrials.gov