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Submitted by: John Michael Dominic Go 2016-08-17 00:00:00 Last Updated by: John Michael Dominic Go 2019-06-20 15:03:37


Evaluation of the immunogenicity and safety of Japanese encephalitis vaccine when given with measles-mumps-rubella vaccine

PHRR160822-001339

JEV06

2016-CT0360

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

This phase 4 open-label trial in which 628 Philippine infants 9 months of age will be randomized 1:1 to one of two arms aims to provide evidence that co-administration of MMR and live attenuated SA 14-14-2 JE vaccine does not adversely affect immunogenicity or safety. With the use of MMR increasing, this study will provide critical data for policy makers considering the use of MMR and/or CD-JEV.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2016-10-01 8 2017-06-01 2019-06-28

Completed

Institution Classification Region LTO #
PATH Private Business United States of America N/A
Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR CDRR-NCR-CRO-1
Institution Region
PATH United States of America
Name E-Mail Institution and Institution Address
Jodi Feser jfeser@path.org 2201 Westlake Avenue, Suite 200, Seattle, WA 98121 USA
Name E-Mail Institution and Institution Address
Jodi Feser jfeser@path.org 2201 Westlake Avenue, Suite 200, Seattle, WA 98121 USA
Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Principal Investigator Research Institute for Tropical Medicine
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

Prevention of Japanese encephalitis disease in 628 healthy Filipino children aged 9 months at enrollment

The rate of seropositivity 56 days after vaccination to demonstrate the non-inferiority of MMR vaccination in terms of measles and rubella immunogenicity when administered concomitantly to infants 9 months of age with CD-JEV compared to administration alone.

1. The rate of seropositivity 56 days after vaccination to demonstrate the non-inferiority of MMR vaccination in terms of mumps immunogenicity when administered concomitantly to infants 9 months of age with CD-JEV compared to administration alone.
2. The geometric mean neutralizing antibody concentration (GMC), anti-mumps IgG mean index standard ratio, and anti-rubella IgG GMC at 56 days post-vaccination to evaluate non-inferiority when MMR vaccine is co-administered with CD-JEV to when MMR vaccine is given alone
3. Seroconversion rates 56 days after MMR vaccination to evaluate the anti-measles, anti-mumps, and anti-rubella response.
4. The rate of seropositivity 28 days after CD-JEV vaccination to compare immunogenicity when administered concomitantly to infants 9 months of age with MMR compared to administration alone.
5. The anti-JE neutralizing antibody geometric mean titers (GMTs) 28 days after CD-JEV vaccination when MMR vaccine is co-administered, compared to when CD-JEV is administered alone.
6. The safety profiles of CD-JEV and MMR vaccine when given concurrently and separately, as assessed by immediate reactions occurring within 30 minutes, solicited injection site and systemic adverse reactions occurring within 14 days, unsolicited adverse events (AEs) occurring within 28 days, and serious adverse events (SAEs) occurring throughout the study.

Completed

  • Philippines

Clinical Trial

JEV06

20160527154740

2016-08-10

0000-00-00

628

628

Unspecified

01 Oct 2016

Each participant receiving study vaccines must satisfy all of the following inclusion criteria at study entry:
        Age 9 months to         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:
No participant may have any of the following exclusion criteria at study entry:
        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 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.

Interventional

Prequalified live, attenuated SA 14-14-2 JE vaccine (CD-JEV)

Administered via injection

None

Randomized

Open Label

Unspecified

Parallel

This non-inferiority study aims to provide evidence that co-administration of MMR and CD-JEV does not adversely affect immunogenicity or safety. With the use of MMR increasing, this study will provide critical data for policy makers considering the use of MMR and/or CD-JEV

Phase IV

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