Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants (BabyCOVE)

A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months

The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months.

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: mRNA-1273.214; Other: Placebo

Detailed Description

The purpose of this pediatric study was to confirm safety and effectiveness of mRNA-1273.214 in infants between 12 weeks to < 6 months of age by comparing the immune response of infants in this study to adults (>18 years of age) enrolled in the mRNA-1273-P301 study [NCT04470427]).

The study was planned to be conducted in 2 parts. Part 1 was open-label and evaluated 2 dose levels. The dose level selected from Part 1 was planned to be further evaluated in Part 2. However, data from the dose finding part of the trial (Part 1) did not support further evaluation of effectiveness of mRNA-1273 and accordingly, Part 2 of the study was not conducted and the trial was terminated. There were no safety concerns.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Bessemer, Alabama, United States, 35022
      • Trinity Clinical Research, LLC - Bessemer
    • Birmingham, Alabama, United States, 35233
      • UAB Pediatrics
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • California
    • Madera, California, United States, 93637
      • Madera Family Medical Group
    • Montebello, California, United States, 90640
      • SeraCollection Research Services LLC
    • Paramount, California, United States, 90723
      • Center For Clinical Trials LLC
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Meridian Clinical Research (Washington) - PPDS
  • Florida
    • Clearwater, Florida, United States, 33756
      • PAS Research
    • Doral, Florida, United States, 33166
      • Prohealth Research Center
    • Jacksonville, Florida, United States, 32209
      • University of Florida Jackonsville
    • Kissimmee, Florida, United States, 34741
      • Kissimmee Clinical Research
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates LLC - ERN - PPDS
    • Miami, Florida, United States, 33155
      • D&H National Research Centers
    • Miami, Florida, United States, 33142-2946
      • Acevedo Clinical Research
    • Miami Gardens, Florida, United States, 33169
      • Excellence Medical and Research LLC
    • Saint Cloud, Florida, United States, 34769
      • KM International Research Operation - Saint Cloud
    • Tampa, Florida, United States, 33613
      • PAS Research
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Medical Research Partners- Ammon
  • Louisiana
    • Covington, Louisiana, United States, 70433-7237
      • MedPharmics - Platinum - PPDS
    • Lafayette, Louisiana, United States, 70508
      • MedPharmics - Platinum - PPDS
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies
  • New York
    • East Syracuse, New York, United States, 13057
      • Child Health Care Associates
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Velocity Clinical Research (Hastings - Nebraska) - PPDS
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15123
      • UPMC University Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • South Texas Clinical Research - Corpus Christi
    • Dallas, Texas, United States, 75251
      • Cedar Health Research - Dedicated Research Facility
    • Houston, Texas, United States, 77065-5471
      • DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS
    • Pearland, Texas, United States, 77584
      • Advances In Health Inc
    • Port Lavaca, Texas, United States, 77979
      • Victoria Clinical Research Group
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • Syracuse, Utah, United States, 84075
      • Wee Care Pediatrics
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research LLC
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: mRNA-1273.214 Dose A; Participants will receive 2 doses of mRNA-1273.214 Dose A by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).	Biological: mRNA-1273.214; Sterile liquid for injection
Experimental: Part 1: mRNA-1273.214 Dose B; Participants will receive 2 doses of mRNA-1273.214 Dose B by IM injection approximately 8 weeks apart (Day 1 and Day 57).	Biological: mRNA-1273.214; Sterile liquid for injection
Experimental: Part 2: mRNA-1273.214; Participants will receive 2 doses of mRNA-1273.214 by IM injection approximately 8 weeks apart (Day 1 and Day 57).	Biological: mRNA-1273.214; Sterile liquid for injection
Placebo Comparator: Part 2: Placebo; Participants will receive 2 doses of placebo by IM injection approximately 8 weeks apart (Day 1 and Day 57).	Other: Placebo; 0.9% sodium chloride; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Injection	Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to <6 months) of the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. ARs graded 1-4 are presented. Lower scores indicated lower severity, and higher scores indicated greater severity. A summary of serious adverse events (SAEs) and nonserious adverse events (AEs) (Safety Set), regardless of causality, is located in the AE section.	Day 1 up to 7 days after first vaccination (up to Day 8)
Number of Participants With Solicited Local and Systemic ARs After Second Injection	Solicited ARs (local and systemic) were collected in eDiary. Local ARs included injection site pain/tenderness, injection site erythema (redness), injection site swelling/induration (hardness), and groin or underarm swelling or tenderness ipsilateral to the side of injection. Systemic ARs included fever, irritability/crying, sleepiness, and loss of appetite. Solicited AR severity was graded according to a modified version (relevant to age 12 weeks to <6 months) of the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. ARs graded 1-4 are presented. Lower scores indicated lower severity, and higher scores indicated greater severity. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section.	Day 57 up to 7 days after second vaccination (up to Day 64)
Number of Participants With Unsolicited Adverse Events (AEs) After Any Injection	An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (onset after Day 7 of dosing). An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result or other safety assessment, including one that worsened from baseline and was considered clinically significant by the Investigator was recorded as an AE. A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section. COVID-19/SARS-CoV-2 infections were considered clinical events and not AEs.	Day 1 up to 28 days after any vaccination (up to Day 85)
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation	SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. MAAE was an AE that led to an unscheduled visit to a healthcare practitioner, included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and visits to healthcare practitioners external to the study site [for example, urgent care, primary care physician]). A summary of SAEs and nonserious AEs (Safety Set), regardless of causality, is located in the AE section. COVID-19/SARS-CoV-2 infections were considered clinical events and not AEs.	Day 1 up to Day 422

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMC) of Serum Pseudovirus Neutralizing Antibod (nAb) Titers Against SARS-CoV-2 Omicron BA.1 Variant (B.1.1.529) After Second Dose of mRNA-1273.214	Pseudovirus nAb were measured using pseudovirus neutralization assay (PsVNA). Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. VAC122 nAb against the SARS-CoV-2 B.1.1.529 variant (LLOQ: 8 arbitrary unit (AU)/milliliter (mL), ULOQ: 24503 AU/mL).	Baseline and 28 days after second dose (Day 85)
GMC of Serum Pseudovirus nAb Titers Against SARS-CoV-2 Original Strain (D614G) After Second Dose of mRNA-1273.214	Pseudovirus nAb were measured using PsVNA assay. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. VAC62 Neutralizing Antibody against D614G (LLOQ: 10 AU/mL, ULOQ: 111433 AU/mL).	Baseline and 28 days after second dose (Day 85)

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID 19; Coronavirus; SARS-CoV-2 Vaccine; Virus Diseases; Moderna; Messenger RNA; mRNA-1273 vaccine; mRNA-1273; mRNA-1273.214; mRNA-1273.214 vaccine; COVID 19 Vaccine; Bivalent omicron vaccine; Omicron vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Virus Diseases; Coronavirus Infections; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution; mRNA-1273.214 COVID-19 vaccine
• Other Study ID Numbers: mRNA-1273-P206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No