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Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age

NCT03204227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-09-17

No results posted yet for this study

Summary

A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start of first dose to 28-34 days after second dose).

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

JEVAX

JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval

BIOLOGICAL

JECEVAX

JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days

Sponsors & Collaborators

  • Ministry of Science and Technology, Vietnam

    collaborator OTHER_GOV

  • Ministry of Health, Vietnam

    collaborator OTHER_GOV

  • National Institute of Hygiene and Epidemiology, Vietnam

    lead OTHER

Principal Investigators

  • Thiem D Vu, MD., PhD. · National Institute of Hygiene and Epidemiology, Vietnam

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2017-08-12
Completion
2017-08-12

Countries

  • Vietnam

Study Locations

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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 NCT03204227 on ClinicalTrials.gov