Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months
- Conditions
- Measles-Mumps-Rubella
- Interventions
- Biological: GSK MMR Vaccine (PRIORIX)Biological: SIBP MMR VaccineBiological: Yellow Fever Vaccine (Stamaril)
- Registration Number
- NCT06399003
- Lead Sponsor
- Shanghai Institute Of Biological Products
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GSK MMR vaccine group GSK MMR Vaccine (PRIORIX) Received a single dose of GSK MMR vaccine alone at D1. Joint vaccination group SIBP MMR Vaccine Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1. Joint vaccination group Yellow Fever Vaccine (Stamaril) Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1. SIBP MMR vaccine group SIBP MMR Vaccine Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43. SIBP MMR vaccine group Yellow Fever Vaccine (Stamaril) Received a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed Yellow Fever (YF) vaccine alone at 2nd dose on D43.
- Primary Outcome Measures
Name Time Method Difference of seropositivity rate 42 days An evaluation of seropositivity rate to Measles, Mumps and Rubella viruses of SIBP MMR vaccine versus GSK MMR vaccine when measured 42 days after vaccination in seronegative children at baseline.
- Secondary Outcome Measures
Name Time Method The percentage of serious adverse events (SAEs) 42 days The percentage of SAEs reported up to 42 days and up to 6 months after first vaccination.
Seropositivity rate of Measles 42 days Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination.
The percentage of solicited local reactogenicity 7 days The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination.
The percentage of unsolicited AEs 42 days The percentage of unsolicited AEs in subjects through 42 days after each vaccination.
The percentage of immediate adverse events (AEs) 30 minutes The percentage of any adverse events in subjects within 30 minutes after each vaccination.
The percentage of solicited systemic reactogenicity 14 days The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination.
Geometric mean titer (GMT) of Yellow Fever 42 days Geometric mean titer (GMT) for anti-yellow fever virus neutralizing antibodies at baseline and 42 days after vaccination.
Geometric mean concentration (GMC) of Measles 42 days Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination.
Geometric mean concentration (GMC) of Rubella 42 days Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination.
Seropositivity rate of Mumps 42 days Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination.
Seropositivity rate of Rubella 42 days Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination.
Geometric mean concentration (GMC) of Mumps 42 days Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination.
Trial Locations
- Locations (1)
Victoria Biomedical Research Institute(VIBRI)
🇰🇪Kisumu, Kenya