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COVID vaccine trial for babies halted early – Here's what we know

NCT ID NCT05584202

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at whether the mRNA-1273.214 COVID-19 vaccine is safe and works in infants as young as 12 weeks to under 6 months old. It was a small, early-stage trial that was stopped before completion. The main goal was to check for side effects like fever, fussiness, and injection site reactions.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Started

Sep 2022

Finished

Nov 2024

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

2 to 6 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.

Key Inclusion Criteria: * Participant is male or female, between 2 and \<6 months of age at the time of consent (Screening Visit), who is in good general health, in the opinion of the investigator, based on review of medical history and screening physical examination. 1. Participant must be at least 12 weeks completed age and must not have completed 6 months at the time of administration of first dose. 2. If the participant has a chronic, stable disease, they may be eligible to enroll in Part 2, but ineligible for Part 1. The chronic condition (for example, gastroesophageal reflux disease) should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion in Part 2. * Participant was born at ≥37 weeks gestation (Part 1) or ≥34 weeks gestation (Part 2), with a minimum birth weight of 2.5 kilograms (kg), without fetal growth restriction, and the participant's height and weight are both at or above the second percentile for age according to the Centers for Disease Control and Prevention/World Health Organization Child Growth Standard at the Screening Visit. * In the investigator's opinion, the parent(s)/legally authorized representative(s) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures, and provide written informed consent. Key Exclusion Criteria: * Participant has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of study drug or has a known close contact in the past 2 weeks to someone diagnosed with SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19). Participants may be rescreened after 14 days provided that they remain asymptomatic. * Participant is acutely ill or febrile 72 hours prior to or at the Screening Visit. Fever is defined as a body temperature ≥38.0°Celcius/≥100.4°Farenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. * Participant has previously been administered an investigational or approved CoV (for example, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome \[MERS\]-CoV) vaccine. * Participant has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (for example, receipt of SARS-CoV-2 monoclonal antibodies) within 90 days prior to enrollment. * Participant has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to any of the components of messenger ribonucleic acid (mRNA) COVID-19 vaccines (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate). * Participant has a medical, psychiatric, or occupational condition, that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. * Participant has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. * Participant has received the following: 1. Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to first or second vaccination or plans to receive such a vaccine within 14 days of any study vaccination. 2. Systemic immunosuppressants or immune-modifying drugs (including maternal use during pregnancy or lactation) for \>14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥ 1 milligrams (mg)/kg/day or, if participant weighs \>10 kg: ≥10 mg/day prednisone equivalent). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed. 3. Intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to enrollment. * Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit or plans to do so while participating in this study, or maternal participation in an interventional clinical study during pregnancy. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease viral infectious disease COVID-19 prevention target

As listed by the trial registrant

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

SARS-CoV-2

Contacts and locations

Locations

  • Acevedo Clinical Research

    Miami, Florida, 33142-2946, United States

  • Advances In Health Inc

    Pearland, Texas, 77584, United States

  • Be Well Clinical Studies

    Lincoln, Nebraska, 68516, United States

  • Cedar Health Research - Dedicated Research Facility

    Dallas, Texas, 75251, United States

  • Center For Clinical Trials LLC

    Paramount, California, 90723, United States

  • Child Health Care Associates

    East Syracuse, New York, 13057, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Clinical Research Institute, Inc

    Minneapolis, Minnesota, 55402, United States

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226, United States

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414, United States

  • D&amp;H National Research Centers

    Miami, Florida, 33155, United States

  • DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS

    Houston, Texas, 77065-5471, United States

  • Eclipse Clinical Research

    Tucson, Arizona, 85745, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Excellence Medical and Research LLC

    Miami Gardens, Florida, 33169, United States

  • KM International Research Operation - Saint Cloud

    Saint Cloud, Florida, 34769, United States

  • Kissimmee Clinical Research

    Kissimmee, Florida, 34741, United States

  • Madera Family Medical Group

    Madera, California, 93637, United States

  • MedPharmics - Platinum - PPDS

    Covington, Louisiana, 70433-7237, United States

  • MedPharmics - Platinum - PPDS

    Lafayette, Louisiana, 70508, United States

  • Medical Research Partners- Ammon

    Ammon, Idaho, 83406, United States

  • Meridian Clinical Research (Washington) - PPDS

    Washington D.C., District of Columbia, 20016, United States

  • PAS Research

    Clearwater, Florida, 33756, United States

  • PAS Research

    Tampa, Florida, 33613, United States

  • PI-Coor Clinical Research LLC

    Burke, Virginia, 22015, United States

  • Prohealth Research Center

    Doral, Florida, 33166, United States

  • SeraCollection Research Services LLC

    Montebello, California, 90640, United States

  • South Texas Clinical Research - Corpus Christi

    Corpus Christi, Texas, 78404, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Suncoast Research Associates LLC - ERN - PPDS

    Miami, Florida, 33173, United States

  • Tanner Clinic

    Layton, Utah, 84041, United States

  • Trinity Clinical Research, LLC - Bessemer

    Bessemer, Alabama, 35022, United States

  • UAB Pediatrics

    Birmingham, Alabama, 35233, United States

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • UPMC University Center

    Pittsburgh, Pennsylvania, 15123, United States

  • University of Florida Jackonsville

    Jacksonville, Florida, 32209, United States

  • Velocity Clinical Research (Hastings - Nebraska) - PPDS

    Wilmington, North Carolina, 28401, United States

  • Victoria Clinical Research Group

    Port Lavaca, Texas, 77979, United States

  • Wee Care Pediatrics

    Syracuse, Utah, 84075, United States

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