Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella … (NCT02880865) | Clinical Trial Compass
CompletedPhase 4
Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
Philippines628 participantsStarted 2016-10-13
Plain-language 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.
Who can participate
Age range9 Months – 9 Months
SexALL
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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 \> …
What they're measuring
1
Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination
Timeframe: 56 days after MMR dose 1 vaccination (Day 56)
2
Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination
Timeframe: 56 days after MMR dose 1 vaccination (Day 56)