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Immunogenicity of SA 14-14-2 JE Vaccine

NCT01635816 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2016-11-29

No results posted yet for this study

Summary

The proposed Japanese Encephalitis (JE)Vaccine study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.

Conditions

  • Healthy Infants

Interventions

BIOLOGICAL

JE Vaccine existing facility

Will receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants).

BIOLOGICAL

JE vaccine new plant lot 1

Will receive Lot 1 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).

BIOLOGICAL

JE vaccine new plant lot 2

Will receive Lot 2 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).

BIOLOGICAL

JE vaccine new plant lot 3

Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Bangladesh

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 NCT01635816 on ClinicalTrials.gov