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Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine

NCT01567865 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2018-12-05

Study results available
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Summary

The proposed 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 Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (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 aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is 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

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Vaccine produced in existing facility

Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

BIOLOGICAL

Vaccine produced in new facility

Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • K Zaman, MD · ICCDR,B

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
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 NCT01567865 on ClinicalTrials.gov