Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months

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

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.

Study Overview

• Status: Completed
• Conditions: Measles-Mumps-Rubella
• Intervention / Treatment: Biological: SIBP MMR Vaccine; Biological: Yellow Fever Vaccine (Stamaril); Biological: GSK MMR Vaccine (PRIORIX)

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.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Victoria Biomedical Research Institute(VIBRI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIBP MMR vaccine group; 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.	Biological: SIBP MMR Vaccine; This is a live attenuated measles, mumps, and rubella combined vaccine (Shanghai MMR) in a freeze-dried powder form, developed and manufactured by Shanghai Institute of Biological Products. A single dose of 0.5 mL, containing not less than 3.0 log CCID50 of both live measles virus and rubella virus and 4.3 log CCID50 of live mumps virus. 0.5ml per dose.; Biological: Yellow Fever Vaccine (Stamaril); This is a live, attenuated, lyophilized yellow fever vaccine manufactured by Sanofi Pasteur Europe, Lyon, France. A single dose of 0.5 mL contains with not less than 1000 IU of yellow fever virus 17D-204 strain. 0.5ml per dose.
Active Comparator: GSK MMR vaccine group; Received a single dose of GSK MMR vaccine alone at D1.	Biological: GSK MMR Vaccine (PRIORIX); PRIORIX (combined measles, mumps and rubella vaccine, live, attenuated) is a lyophilized mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella). 0.5ml per dose.
Experimental: Joint vaccination group; Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1.	Biological: SIBP MMR Vaccine; This is a live attenuated measles, mumps, and rubella combined vaccine (Shanghai MMR) in a freeze-dried powder form, developed and manufactured by Shanghai Institute of Biological Products. A single dose of 0.5 mL, containing not less than 3.0 log CCID50 of both live measles virus and rubella virus and 4.3 log CCID50 of live mumps virus. 0.5ml per dose.; Biological: Yellow Fever Vaccine (Stamaril); This is a live, attenuated, lyophilized yellow fever vaccine manufactured by Sanofi Pasteur Europe, Lyon, France. A single dose of 0.5 mL contains with not less than 1000 IU of yellow fever virus 17D-204 strain. 0.5ml per dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of seropositivity rate	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.	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of immediate adverse events (AEs)	The percentage of any adverse events in subjects within 30 minutes after each vaccination.	30 minutes
The percentage of solicited local reactogenicity	The percentage of solicited local reactogenicity in subjects through 7 days after each vaccination.	7 days
The percentage of solicited systemic reactogenicity	The percentage of solicited systemic reactogenicity in subjects through 14 days after each vaccination.	14 days
The percentage of unsolicited AEs	The percentage of unsolicited AEs in subjects through 42 days after each vaccination.	42 days
The percentage of serious adverse events (SAEs)	The percentage of SAEs reported up to 42 days and up to 6 months after first vaccination.	42 days
Geometric mean titer (GMT) of Yellow Fever	Geometric mean titer (GMT) for anti-yellow fever virus neutralizing antibodies at baseline and 42 days after vaccination.	42 days
Geometric mean concentration (GMC) of Measles	Geometric mean concentration (GMC) for anti-measles IgG antibodies at baseline and 42 days after vaccination.	42 days
Geometric mean concentration (GMC) of Mumps	Geometric mean concentration (GMC) for anti-mumps IgG antibodies at baseline and 42 days after vaccination.	42 days
Geometric mean concentration (GMC) of Rubella	Geometric mean concentration (GMC) for anti-rubella IgG antibodies at baseline and 42 days after vaccination.	42 days
Seropositivity rate of Measles	Seropositivity rate for measles antigen as measured by antibody titers at baseline and 42 days after vaccination.	42 days
Seropositivity rate of Mumps	Seropositivity rate for mumps antigen as measured by antibody titers at baseline and 42 days after vaccination.	42 days
Seropositivity rate of Rubella	Seropositivity rate for rubella antigen as measured by antibody titers at baseline and 42 days after vaccination.	42 days

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products
• Collaborators: Victoria Biomedical Research Institute
• Investigators: Principal Investigator: Walter Otieno, Doctor, Victoria Biomedical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Measles, Mumps and Rubella; 9-11 months of Age
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; RNA Virus Infections; Virus Diseases; Salivary Gland Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Morbillivirus Infections; Togaviridae Infections; Rubivirus Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Measles; Rubella; Mumps; Biological Products; Complex Mixtures; Vaccines; Vaccines, Combined; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Measles-Mumps-Rubella Vaccine; Yellow Fever Vaccine
• Other Study ID Numbers: SIBP-MMR-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No