Clinical trial NCT06399003: Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months
Official title: A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBP's MMR Vaccine Compared to GSK MMR Vaccine in Children, 9-11 Months of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Measles-Mumps-Rubella
Keywords: Measles, Mumps and Rubella
Immunogenicity
Safety
9-11 months of Age
Lead sponsor: Shanghai Institute Of Biological Products
Sponsor class: INDUSTRY
Collaborators: name: Victoria Biomedical Research Institute
First posted: 2024-05-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrolled children will be randomized to three groups in the ratio of 1:1:1 receiving different vaccines.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Difference of seropositivity rate
timeFrame: 42 days
Secondary outcomes:
measure: The percentage of immediate adverse events (AEs)
timeFrame: 30 minutes
measure: The percentage of solicited local reactogenicity
timeFrame: 7 days
measure: The percentage of solicited systemic reactogenicity
timeFrame: 14 days
measure: The percentage of unsolicited AEs
timeFrame: 42 days
measure: The percentage of serious adverse events (SAEs)
timeFrame: 42 days
measure: Geometric mean titer (GMT) of Yellow Fever
timeFrame: 42 days
measure: Geometric mean concentration (GMC) of Measles
timeFrame: 42 days
measure: Geometric mean concentration (GMC) of Mumps
timeFrame: 42 days
measure: Geometric mean concentration (GMC) of Rubella
timeFrame: 42 days
measure: Seropositivity rate of Measles
timeFrame: 42 days
measure: Seropositivity rate of Mumps
timeFrame: 42 days
measure: Seropositivity rate of Rubella
timeFrame: 42 days
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Victoria Biomedical Research Institute(VIBRI)
Study officials:
affiliation: Victoria Biomedical Research Institute
name: Walter Otieno, Doctor
role: PRINCIPAL_INVESTIGATOR
References: