comparison study of sibp's mmr vaccine versus gsk mmr vaccine in children aged 9-11 months

Conditions: Measles-Mumps-Rubella

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.

this study is designed as a phase iii, multi-center, randomized, observer blind active controlled non-inferiority study, enrolling 1200 healthy african children between the ages of 9-11 months. the enrolled children will be randomized to three groups in the ratio of 1:1:1 (400 children in each group) receiving a single dose of sibp mmr vaccine alone at 1st dose on d1 and licensed yf vaccine alone at 2nd dose on d43 (group 1, mmr1yf2) or a single dose of gsk mmr vaccine alone at d1 (group 2, gsk mmr1) or a single dose of sibp mmr vaccine co-administered with yf vaccine on d1 (group 3, mmr1yf1). this study will have an observer-blinded phase for group 1 and group 2 followed by an open label phase from day 43. group 3 will remain an open label arm throughout the period of the study.

Eligibility criteria:
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 to result in nonconformance to the protocol. * known or suspected impairment of immunological function based on medical history and physical examination. * prior receipt or intent to receive measles, mumps, rubella, or yellow fever-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 the day of study vaccination or intent to receive any within 6 weeks after study vaccination. * receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period * receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine 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 of body 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 be permitted to participate in the study. * evidence of a clinically significant major congenital anomaly or genetic defect as judged by the investigator. * any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection. * history of any neurologic disorders including encephalopathy, epilepsy, and other progressive neurological diseases * a known or suspected sensitivity or allergy to any components of the investigational product including egg, chicken protein and the antibiotic gentamycin. * history of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. * any medical condition in the parent/lar or child which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent(s)'/lar's ability to give informed consent.

Keywords: measles, mumps and rubella immunogenicity safety 9-11 months of age