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

NCT06399003 | Completed Phase 3 DMC

• 1 other identifier: SIBP-MMR-02
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Measles-Mumps-Rubella

Keywords

Measles, Mumps and Rubella; Immunogenicity; Safety; 9-11 months of Age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• The percentage of immediate adverse events (AEs)

  30 minutes

• The percentage of solicited local reactogenicity

  7 days

• The percentage of solicited systemic reactogenicity

  14 days

• The percentage of unsolicited AEs

  42 days

• The percentage of serious adverse events (SAEs)

  42 days

Study Arms (3)

SIBP MMR vaccine group

EXPERIMENTAL

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; Biological: Yellow Fever Vaccine (Stamaril)

GSK MMR vaccine group

ACTIVE COMPARATOR

Received a single dose of GSK MMR vaccine alone at D1.

Biological: GSK MMR Vaccine (PRIORIX)

Joint vaccination group

EXPERIMENTAL

Received a single dose of SIBP MMR vaccine co-administered with Yellow Fever vaccine on D1.

Biological: SIBP MMR Vaccine; Biological: Yellow Fever Vaccine (Stamaril)

Interventions

SIBP MMR Vaccine BIOLOGICAL

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.

Joint vaccination group; SIBP MMR vaccine group

GSK MMR Vaccine (PRIORIX) BIOLOGICAL

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.

GSK MMR vaccine group

Yellow Fever Vaccine (Stamaril) BIOLOGICAL

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.

Joint vaccination group; SIBP MMR vaccine group

Eligibility Criteria

• Age: 9 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead
• Victoria Biomedical Research Institute: collaborator

Study Sites (1)

Victoria Biomedical Research Institute(VIBRI)

Kisumu, Kenya

Location

MeSH Terms

Conditions

Measles; Mumps; Rubella

Interventions

Measles-Mumps-Rubella Vaccine; Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Walter Otieno, Doctor

  Victoria Biomedical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The enrolled children will be randomized to three groups in the ratio of 1:1:1 receiving different vaccines.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: June 28, 2024
• Primary Completion: September 15, 2024
• Study Completion: March 10, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)