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Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT02880865•PATH

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age 9 months to \< 10 months at the time of enrollment.
•Residence in the study area.
•At least one parent or guardian willing to provide written informed consent.
•Generally healthy and free of obvious health problems as established by medical history, physical examination, and clinical judgment.
•A parent or guardian is willing to attend all planned study visits and allow home visits and phone contacts, as required by the protocol.

Exclusion Criteria

•Previous receipt of any measles-mumps-rubella containing vaccine.
•Previous receipt of any Japanese encephalitis vaccine.
•History of measles, mumps, rubella, or Japanese encephalitis infection.
•Administration of any other vaccine within 28 days prior to administration of a study vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI vaccines or oral polio vaccine during the 28 days after study vaccination.
•History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization.
•Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines or planned administration during the study period.
•Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the study period.
•Chronic administration (defined as \> 7 days) of immunosuppressing or other immune-modifying agents within 14 days before or after vaccination (including systemic corticosteroids equivalent to prednisone ≥ 0.5 mg/kg/day; topical and inhaled steroids are allowed).
•Primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency as reported by parent.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which might interfere with the study objectives.
+3 more criteria

Locations (1)

Research Institute for Tropical Medicine

Manila, Philippines

Key Dates

Start Date

October 13, 2016

Primary Completion Date

May 19, 2017

Completion Date

July 11, 2017

Last Updated

October 14, 2020

Enrollment

628

ACTUAL participants

Conditions

Encephalitis, JapaneseMeaslesMumpsRubella

Interventions

Live attenuated SA 14-14-2 Japanese Encephalitis vaccine

BIOLOGICAL

Measles, mumps, rubella vaccine

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections

Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children

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