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Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age

NCT00463684 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2019-02-08

Study results available
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Summary

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater than 80% for JE and greater than 90% for measles.

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine

Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.

BIOLOGICAL

Live, attenuated measles vaccine

Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Sponsors & Collaborators

  • Ministry of Health of Sri Lanka

    collaborator UNKNOWN

  • Mahidol University

    collaborator OTHER

  • Quintiles Singapore

    collaborator UNKNOWN

  • PATH

    lead OTHER

Principal Investigators

  • Nihal Abeysinghe, MD, MSc · Epidemiological Unit, Sri Lanka Ministry of Healthcare and Nutrition

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-07-07
Primary Completion
2007-11-07
Completion
2008-10-06

Countries

  • Sri Lanka

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 NCT00463684 on ClinicalTrials.gov