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Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

NCT00441259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-08-27

Study results available
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Summary

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period.

Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

ChimeriVax™-JE

One dose of 4.0 log10 PFU is given in a volume of 1 ml for children aged \> 3 years and 0.5 ml to children and infants aged \< 3 years administered subcutaneously

BIOLOGICAL

Japanese Encephalitis Inactivated Mouse Brain Vaccine

Two doses of 1 ml reconstituted JE-MBDV is given to subjects aged \> 3 years and 0.5 ml is given to children and infants aged \< 3 years administered subcutaneously

Sponsors & Collaborators

Principal Investigators

  • Anand Dubey, M.D · Maulana Azad Medical College, New Delhi, India

  • Bakul B. Javadekar, M.D. · Government Medical College, Baroda, India

  • Atul Shanker, Dr. · Dr Atul's Child Hospital, Jaipur, Rajasthan, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-02-28
Completion
2011-12-31

Countries

  • India

Study Locations

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Entities

Companies

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 NCT00441259 on ClinicalTrials.gov