Phase
Condition
Rash
Throat And Tonsil Infections
Treatment
GSK MMR Vaccine (PRIORIX)
SIBP MMR Vaccine
Yellow Fever Vaccine (Stamaril)
Clinical Study ID
Ages 9-11 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy male and female child as established by medical history and clinicalexamination at enrollment.
Age: 9-11 months (inclusive) at the time of enrollment
Parent's/legally acceptable representative's (LAR) ability to read and willingnessto provide written informed consent as per the ethical and regulatory requirementsof the site.
Parent confirms intention to stay in the study area for the study duration, bringtheir child in for the required study visits or to accept a home visit by the studystaff.
Exclusion
Exclusion Criteria:
Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusionuntil recovery)
Acute disease of moderate to severe intensity at the time of enrollment (temporaryexclusion until recovery)
Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusionuntil recovery)
Prior (within 6 months) or concurrent participation in another interventionalclinical trial during the study
Presence of severe malnutrition (weight-for-height z-score < -3SD median)
Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis
Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal,gastrointestinal, hematological (including severe anemia), endocrine, immunological,dermatological, neurological, cancer, or autoimmune disease) as determined bymedical history and / or physical examination which would compromise theparticipant's health or is likely to result in nonconformance to the protocol.
Known or suspected impairment of immunological function based on medical history andphysical examination.
Prior receipt or intent to receive measles, mumps, rubella, or yellowfever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center.
Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of theday of study vaccination or intent to receive any within 6 weeks after studyvaccination.
Receipt of immunoglobulin therapy and / or blood products in the past 9 months orplanned administration during the study period
Receipt of any immune-modifying or immunosuppressant drugs prior to the first studyvaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as ≥2 mg/kg ofbody weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg)will be exclusionary for the study. Children on inhaled or topical steroids may bepermitted to participate in the study.
Evidence of a clinically significant major congenital anomaly or genetic defect asjudged by the investigator.
Any known or suspected bleeding disorder in the participant that would pose a riskto venipuncture or intramuscular injection.
History of any neurologic disorders including encephalopathy, epilepsy, and otherprogressive neurological diseases
A known or suspected sensitivity or allergy to any components of the investigationalproduct including egg, chicken protein and the antibiotic gentamycin.
History of severe allergic reaction with generalized urticaria, angioedema, oranaphylaxis.
Any medical condition in the parent/LAR or child which, in the judgment of theInvestigator, would interfere with or serves as a contraindication to protocoladherence or a participant's parent(s)'/LAR's ability to give informed consent.
Study Design
Study Description
Connect with a study center
Victoria Biomedical Research Institute(VIBRI)
Kisumu,
KenyaActive - Recruiting
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