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

NCT ID: NCT02880865

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 628 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-13
• Study Completion Date: 2017-07-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1 - MMR and CD-JEV

Participants receiving one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0; Group 1 will also receive a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).

Group Type: EXPERIMENTAL

Live attenuated SA 14-14-2 Japanese Encephalitis vaccine

Intervention Type: BIOLOGICAL

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 vaccine

Intervention Type: BIOLOGICAL

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.

Group 2 - MMR then CD-JEV

Participants receiving one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Group 2 will receive a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).

Group Type: EXPERIMENTAL

Live attenuated SA 14-14-2 Japanese Encephalitis vaccine

Intervention Type: BIOLOGICAL

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 vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

CD-JEV; CD.JEVAX®; RS.JEV®; MMR; Priorix®

Eligibility Criteria

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.
• Severely malnourished infants as measured by World Health Organization weight-for-height tables (Z-score < -3).
• Any condition or criterion that, in the opinion of the study physician, might compromise the well-being of the participant, compliance with study procedures, or interpretation of the outcomes of the study.
• Acute illness at the time of enrollment defined as the presence of a moderate or severe illness with fever (axillary temperature ≥ 38.0°C) or without fever (severity determined at the discretion of the study physician). Acute illness is a temporary exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for reassessment may be scheduled 7 days or more after temporary exclusion illness is resolved. Eligibility for study participation must be reassessed again at the next visit.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Institute for Tropical Medicine

OTHER_GOV

Sponsor Role: collaborator

Syneos Health

OTHER

Sponsor Role: collaborator

DFNet Research Inc.

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Rosario Capeding, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Tropical Medicine

Locations

Research Institute for Tropical Medicine

Manila, , Philippines

Countries

Philippines

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PHRR160822-001339

Identifier Type: REGISTRY

Identifier Source: secondary_id

JEV06

Identifier Type: -

Identifier Source: org_study_id