CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 278 enrolled
Drug / intervention
Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00463684
NCT00463684Phase 4Completed

Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka

PATH·interventional·Posted Apr 20, 2007·Updated Feb 8, 2019

In Brief

A Phase 4 clinical trial evaluating Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine and Live, attenuated measles vaccine for Japanese Encephalitis. Completed, enrolled 278 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSri Lanka

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2007
Enrollment StartJul 7, 2007
Primary CompletionNov 7, 2007
Study CompletionOct 6, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 19.2 years ago

Interventions

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

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

Live, attenuated measles vaccinebiological

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