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

Last updated: October 15, 2024
Sponsor: Shanghai Institute Of Biological Products
Overall Status: Active - Recruiting

Phase

3

Condition

Rash

Throat And Tonsil Infections

Treatment

GSK MMR Vaccine (PRIORIX)

SIBP MMR Vaccine

Yellow Fever Vaccine (Stamaril)

Clinical Study ID

NCT06399003
SIBP-MMR-02
  • Ages 9-11
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male and female child as established by medical history and clinicalexamination at enrollment.

  • Age: 9-11 months (inclusive) at the time of enrollment

  • Parent's/legally acceptable representative's (LAR) ability to read and willingnessto provide written informed consent as per the ethical and regulatory requirementsof the site.

  • Parent confirms intention to stay in the study area for the study duration, bringtheir child in for the required study visits or to accept a home visit by the studystaff.

Exclusion

Exclusion Criteria:

  • Presence of fever (defined as axillary temperature ≥ 37.5°C) (temporary exclusionuntil recovery)

  • Acute disease of moderate to severe intensity at the time of enrollment (temporaryexclusion until recovery)

  • Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusionuntil recovery)

  • Prior (within 6 months) or concurrent participation in another interventionalclinical 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 bymedical history and / or physical examination which would compromise theparticipant's health or is likely to result in nonconformance to the protocol.

  • Known or suspected impairment of immunological function based on medical history andphysical examination.

  • Prior receipt or intent to receive measles, mumps, rubella, or yellowfever-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 theday of study vaccination or intent to receive any within 6 weeks after studyvaccination.

  • Receipt of immunoglobulin therapy and / or blood products in the past 9 months orplanned administration during the study period

  • Receipt of any immune-modifying or immunosuppressant drugs prior to the first studyvaccine 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 ofbody 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 bepermitted to participate in the study.

  • Evidence of a clinically significant major congenital anomaly or genetic defect asjudged by the investigator.

  • Any known or suspected bleeding disorder in the participant that would pose a riskto venipuncture or intramuscular injection.

  • History of any neurologic disorders including encephalopathy, epilepsy, and otherprogressive neurological diseases

  • A known or suspected sensitivity or allergy to any components of the investigationalproduct including egg, chicken protein and the antibiotic gentamycin.

  • History of severe allergic reaction with generalized urticaria, angioedema, oranaphylaxis.

  • Any medical condition in the parent/LAR or child which, in the judgment of theInvestigator, would interfere with or serves as a contraindication to protocoladherence or a participant's parent(s)'/LAR's ability to give informed consent.

Study Design

Total Participants: 1200
Treatment Group(s): 3
Primary Treatment: GSK MMR Vaccine (PRIORIX)
Phase: 3
Study Start date:
June 28, 2024
Estimated Completion Date:
June 20, 2025

Study 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.

Connect with a study center

  • Victoria Biomedical Research Institute(VIBRI)

    Kisumu,
    Kenya

    Active - Recruiting

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