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 range
9 Months – 9 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)