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

NCT05584202 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: mRNA-1273-P206
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 39

Brief Summary

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.

Conditions

SARS-CoV-2

Keywords

mRNA-1273; mRNA-1273 vaccine; mRNA-1273.214 vaccine; mRNA-1273.214; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID 19; COVID 19 Vaccine; Moderna; Bivalent omicron vaccine; Omicron vaccine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

  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

  Baseline and 28 days after second dose (Day 85)

Study Arms (4)

Part 1: mRNA-1273.214 Dose A

EXPERIMENTAL

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

Part 1: mRNA-1273.214 Dose B

EXPERIMENTAL

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

Part 2: mRNA-1273.214

EXPERIMENTAL

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

Part 2: Placebo

PLACEBO COMPARATOR

Participants will receive 2 doses of placebo by IM injection approximately 8 weeks apart (Day 1 and Day 57).

Other: Placebo

Interventions

mRNA-1273.214 BIOLOGICAL

Sterile liquid for injection

Part 1: mRNA-1273.214 Dose A; Part 1: mRNA-1273.214 Dose B; Part 2: mRNA-1273.214

Placebo OTHER

0.9% sodium chloride

Also known as: normal saline

Part 2: Placebo

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Participant must be at least 12 weeks completed age and must not have completed 6 months at the time of administration of first dose.
• 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.

You may not qualify if:

• 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:
• 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.
• 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.
• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (39)

Trinity Clinical Research, LLC - Bessemer

Bessemer, Alabama, 35022, United States

Location

UAB Pediatrics

Birmingham, Alabama, 35233, United States

Location

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

SeraCollection Research Services LLC

Montebello, California, 90640, United States

Location

Center For Clinical Trials LLC

Paramount, California, 90723, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Meridian Clinical Research (Washington) - PPDS

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

Location

PAS Research

Clearwater, Florida, 33756, United States

Location

Prohealth Research Center

Doral, Florida, 33166, United States

Location

University of Florida Jackonsville

Jacksonville, Florida, 32209, United States

Location

Kissimmee Clinical Research

Kissimmee, Florida, 34741, United States

Location

Acevedo Clinical Research

Miami, Florida, 33142-2946, United States

Location

D&amp;H National Research Centers

Miami, Florida, 33155, United States

Location

Suncoast Research Associates LLC - ERN - PPDS

Miami, Florida, 33173, United States

Location

Excellence Medical and Research LLC

Miami Gardens, Florida, 33169, United States

Location

KM International Research Operation - Saint Cloud

Saint Cloud, Florida, 34769, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Medical Research Partners- Ammon

Ammon, Idaho, 83406, United States

Location

MedPharmics - Platinum - PPDS

Covington, Louisiana, 70433-7237, United States

Location

MedPharmics - Platinum - PPDS

Lafayette, Louisiana, 70508, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Clinical Research Institute, Inc

Minneapolis, Minnesota, 55402, United States

Location

Be Well Clinical Studies

Lincoln, Nebraska, 68516, United States

Location

Child Health Care Associates

East Syracuse, New York, 13057, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Velocity Clinical Research (Hastings - Nebraska) - PPDS

Wilmington, North Carolina, 28401, United States

Location

UPMC University Center

Pittsburgh, Pennsylvania, 15123, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

South Texas Clinical Research - Corpus Christi

Corpus Christi, Texas, 78404, United States

Location

Cedar Health Research - Dedicated Research Facility

Dallas, Texas, 75251, United States

Location

DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS

Houston, Texas, 77065-5471, United States

Location

Advances In Health Inc

Pearland, Texas, 77584, United States

Location

Victoria Clinical Research Group

Port Lavaca, Texas, 77979, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Wee Care Pediatrics

Syracuse, Utah, 84075, United States

Location

PI-Coor Clinical Research LLC

Burke, Virginia, 22015, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Interventions

mRNA-1273.214 COVID-19 vaccine; Saline Solution

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Based on immunogenicity results from Part 1, Part 2 was not conducted. Results should be interpreted with caution due to the small sample size of Part 1 mRNA-1273.214 10 μg arm. Enrollment in Part 1 10 μg arm was halted as the target variant for the formulation was no longer a variant of concern.

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1: open-label Part 2: observer-blinded, randomized, placebo-controlled
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: sequential Part 2: parallel

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: September 30, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Locations

US (39)