CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 628 enrolled
Drug / intervention
Live attenuated SA 14-14-2 Japanese Encephalitis vaccine +1 morebiological
Likely dose
Live attenuated SA 14-14-2 Japanese Encephalitis vaccine 0.5 mLfrom 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/NCT02880865
NCT02880865Phase 4Completed
CompareCT.gov

Immunogenicity and Safety of Concurrent Administration of Live, Attenuated SA 14-14-2 Japanese Encephalitis Vaccine and Measles-Mumps-Rubella Vaccine in Infants 9-12 Months of Age in the Philippines

PATH·interventional·Posted Aug 26, 2016·Updated Oct 14, 2020

In Brief

A Phase 4 clinical trial evaluating Live attenuated SA 14-14-2 Japanese Encephalitis vaccine and Measles, mumps, rubella vaccine for Encephalitis, Japanese and 3 related conditions. Completed, enrolled 628 participants across 1 site.

Detailed Summary

This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis, Japanese, Measles, Mumps, Rubella
CountriesPhilippines
CollaboratorsResearch Institute for Tropical Medicine, Syneos Health, DFNet Research Inc.

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 26, 2016
Enrollment StartOct 13, 2016
Primary CompletionMay 19, 2017
Study CompletionJul 11, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.8 years ago

Interventions

Live attenuated SA 14-14-2 Japanese Encephalitis vaccinebiological

Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection

Measles, mumps, rubella vaccinebiological

Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.