NCT02880865

Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 9 Months – 9 Months
• Healthy volunteers: Accepted

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.

Detailed description

When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.

Conditions

• Encephalitis, Japanese
• Measles
• Mumps
• Rubella

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated SA 14-14-2 Japanese Encephalitis vaccine	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
BIOLOGICAL	Measles, mumps, rubella vaccine	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.

Timeline

• Start date: 2016-10-13
• Primary completion: 2017-05-19
• Completion: 2017-07-11
• First posted: 2016-08-26
• Last updated: 2020-10-14
• Results posted: 2020-09-18

Locations

1 site across 1 country: Philippines