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

NCT ID: NCT06399003

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2025-03-10

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.

Conditions

Measles-Mumps-Rubella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SIBP MMR Vaccine

Intervention Type: 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.

Yellow Fever Vaccine (Stamaril)

Intervention Type: 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.

GSK MMR vaccine group

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

Group Type: ACTIVE_COMPARATOR

GSK MMR Vaccine (PRIORIX)

Intervention Type: 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.

Joint vaccination group

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

Group Type: EXPERIMENTAL

SIBP MMR Vaccine

Intervention Type: 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.

Yellow Fever Vaccine (Stamaril)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 11 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Victoria Biomedical Research Institute

OTHER

Sponsor Role: collaborator

Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Otieno, Doctor

Role: PRINCIPAL_INVESTIGATOR

Victoria Biomedical Research Institute

Locations

Victoria Biomedical Research Institute(VIBRI)

Kisumu, , Kenya

Countries

Kenya

Other Identifiers

SIBP-MMR-02

Identifier Type: -

Identifier Source: org_study_id