Comparing two MMR vaccines in young children

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

This study is testing a new MMR vaccine against an existing one in healthy African children aged 9-11 months to see which one works better and is safer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 9 Months to 11 Months
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (Kisumu)
• Trial ID: NCT06399003 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the immunogenicity and safety of the Shanghai Institute of Biological Products' MMR vaccine compared to the licensed GSK MMR vaccine in healthy African children aged 9-11 months. The study involves 1200 participants who will be randomized into three groups, receiving different vaccine combinations. The trial includes an observer-blinded phase for two groups and an open-label phase for one group, allowing for comprehensive safety and efficacy assessments.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy children aged 9-11 months living in the study area.

Not a fit: Patients with acute diseases or fever at the time of enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence for a new, effective MMR vaccine option for young children.

How similar studies have performed: Previous studies comparing different MMR vaccines have shown promising results, indicating that this approach is supported by existing evidence.

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.

Where this trial is running

Kisumu

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

Study contacts

• Principal investigator: Walter Otieno, Doctor — Victoria Biomedical Research Institute
• Study coordinator: Dandan Chen, Master

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