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New MMR vaccine shows promise in protecting infants

NCT ID NCT06399003

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new measles, mumps, and rubella (MMR) vaccine made by Shanghai Institute of Biological Products in 1,200 healthy children aged 9-11 months. The goal was to see if it works as well as the licensed GSK MMR vaccine and is safe. Children received one dose, and researchers checked their immune response and any side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,200 people

The number who actually took part.

Started

Jun 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 to 11 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Victoria Biomedical Research Institute(VIBRI)

    Kisumu, Kenya