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

NCT ID: NCT05584202

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-11-15

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.

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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

mRNA-1273.214

Intervention Type: BIOLOGICAL

Sterile liquid for injection

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).

Group Type: EXPERIMENTAL

mRNA-1273.214

Intervention Type: BIOLOGICAL

Sterile liquid for injection

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).

Group Type: EXPERIMENTAL

mRNA-1273.214

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part 2: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0.9% sodium chloride

Interventions

mRNA-1273.214

Sterile liquid for injection

Intervention Type: BIOLOGICAL

Placebo

0.9% sodium chloride

Intervention Type: OTHER

Other Intervention Names

normal saline

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Trinity Clinical Research, LLC - Bessemer

Bessemer, Alabama, United States

UAB Pediatrics

Birmingham, Alabama, United States

Eclipse Clinical Research

Tucson, Arizona, United States

Madera Family Medical Group

Madera, California, United States

SeraCollection Research Services LLC

Montebello, California, United States

Center For Clinical Trials LLC

Paramount, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Meridian Clinical Research (Washington) - PPDS

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

PAS Research

Clearwater, Florida, United States

Prohealth Research Center

Doral, Florida, United States

University of Florida Jackonsville

Jacksonville, Florida, United States

Kissimmee Clinical Research

Kissimmee, Florida, United States

Acevedo Clinical Research

Miami, Florida, United States

D&amp;H National Research Centers

Miami, Florida, United States

Suncoast Research Associates LLC - ERN - PPDS

Miami, Florida, United States

Excellence Medical and Research LLC

Miami Gardens, Florida, United States

KM International Research Operation - Saint Cloud

Saint Cloud, Florida, United States

PAS Research

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Medical Research Partners- Ammon

Ammon, Idaho, United States

MedPharmics - Platinum - PPDS

Covington, Louisiana, United States

MedPharmics - Platinum - PPDS

Lafayette, Louisiana, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Clinical Research Institute, Inc

Minneapolis, Minnesota, United States

Be Well Clinical Studies

Lincoln, Nebraska, United States

Child Health Care Associates

East Syracuse, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Velocity Clinical Research (Hastings - Nebraska) - PPDS

Wilmington, North Carolina, United States

UPMC University Center

Pittsburgh, Pennsylvania, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

South Texas Clinical Research - Corpus Christi

Corpus Christi, Texas, United States

Cedar Health Research - Dedicated Research Facility

Dallas, Texas, United States

DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS

Houston, Texas, United States

Advances In Health Inc

Pearland, Texas, United States

Victoria Clinical Research Group

Port Lavaca, Texas, United States

Tanner Clinic

Layton, Utah, United States

Wee Care Pediatrics

Syracuse, Utah, United States

PI-Coor Clinical Research LLC

Burke, Virginia, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

mRNA-1273-P206

Identifier Type: -

Identifier Source: org_study_id