Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months
- 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.
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2025-03-10
- First posted
- 2024-05-03
- Registry last updated
- 2026-01-08
- Primary completion date
- 2024-09-15
- Start date
- 2024-06-28
- Actual participants
- 1,200
- Participants
- 1,200
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- 1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Institute Of Biological Products
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06399003
- ClinicalTrials.gov ID
- NCT06399003
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Single masking
- Masking description
- 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.
- Masked roles
- Outcome assessors
Difference of seropositivity rate
Timeframe: 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.
The percentage of immediate adverse events (AEs)
Timeframe: 30 minutes
The percentage of any adverse events in subjects within 30 minutes after each vaccination.
The percentage of solicited local reactogenicity
Timeframe: 7 days
The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination.
The percentage of solicited systemic reactogenicity
Timeframe: 14 days
The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination.
The percentage of unsolicited AEs
Timeframe: 42 days
The percentage of unsolicited AEs in subjects through 42 days after each vaccination.
The percentage of serious adverse events (SAEs)
Timeframe: 42 days
The percentage of SAEs reported up to 42 days and up to 6 months after first vaccination.
Geometric mean titer (GMT) of Yellow Fever
Timeframe: 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
Timeframe: 42 days
Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination.
Geometric mean concentration (GMC) of Mumps
Timeframe: 42 days
Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination.
Geometric mean concentration (GMC) of Rubella
Timeframe: 42 days
Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination.
Seropositivity rate of Measles
Timeframe: 42 days
Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination.
Seropositivity rate of Mumps
Timeframe: 42 days
Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination.
Seropositivity rate of Rubella
Timeframe: 42 days
Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination.
- Sex
- All
- Age groups
- Children
- Minimum age
- 9 Months
- Maximum age
- 11 Months
- Healthy volunteers
- Yes
- 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.
- Victoria Biomedical Research Institute(VIBRI)Kisumu, Kenya
Related records
Drugs (1)
Collaborators (1)
- Victoria Biomedical Research Institute