Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months (NCT06399003) | Clinical Trial Compass
CompletedPhase 3
Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months
Kenya1,200 participantsStarted 2024-06-28
Plain-language summary
To evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.'s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9-11 Months of Age.
Who can participate
Age range9 Months – 11 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male and female child as established by medical history and clinical examination at enrollment.
* Age: 9-11 months (inclusive) at the time of enrollment
* Parent's/legally acceptable representative's (LAR) ability to read and willingness to provide written informed consent as per the ethical and regulatory requirements of the site.
* Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff.
Exclusion Criteria:
* Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusion until recovery)
* Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery)
* Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)
* Prior (within 6 months) or concurrent participation in another interventional clinical 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 by medical history and / or physical examination which would compromise the participant's health or is likely …