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 will evaluate 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: Recruiting
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: mRNA-1273.214; Other: Placebo

Detailed Description

The study will be conducted in 2 parts. Part 1 will be open-label and evaluate 2 dose levels. The dose level selected from Part 1 will be further evaluated in Part 2, which will be blinded and randomized. This pediatric study is intended 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]).

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Moderna Clinical Trials Support Center; Phone Number: 1-877-777-7187; Email: clinicaltrials@modernatx.com

Study Locations

• United States
  • Alabama
    • Bessemer, Alabama, United States, 35022
      • Not yet recruiting
      • Trinity Clinical Research, LLC - Bessemer
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • UAB Pediatrics
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Not yet recruiting
      • Eclipse Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Withdrawn
      • Arkansas Children's Research Hospital
  • California
    • La Jolla, California, United States, 92037
      • Withdrawn
      • UCSD Altman Clinical and Translational Research
    • Madera, California, United States, 93637
      • Not yet recruiting
      • Madera Family Medical Group
    • Montebello, California, United States, 90640
      • Recruiting
      • SeraCollection Research Services LLC
    • Paramount, California, United States, 90723
      • Not yet recruiting
      • Center For Clinical Trials LLC
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Recruiting
      • Meridian Clinical Research (Washington) - PPDS
  • Florida
    • Clearwater, Florida, United States, 33756
      • Not yet recruiting
      • Pas Research
    • Doral, Florida, United States, 33166
      • Recruiting
      • Prohealth Research Center
    • Jacksonville, Florida, United States, 32209
      • Recruiting
      • University of Florida Jackonsville
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • Kissimmee Clinical Research
    • Miami, Florida, United States, 33142-2946
      • Recruiting
      • Acevedo Clinical Research
    • Miami, Florida, United States, 33142-3911
      • Withdrawn
      • L&A Morales Healthcare, Inc
    • Miami, Florida, United States, 33173
      • Recruiting
      • Suncoast Research Associates LLC - ERN - PPDS
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • D&H National Research Centers
    • Miami, Florida, United States, 33174-3245
      • Not yet recruiting
      • Dedicated Research Facility
    • Miami Gardens, Florida, United States, 33169
      • Not yet recruiting
      • Excellence Medical and Research LLC
    • Saint Cloud, Florida, United States, 34769
      • Not yet recruiting
      • KM International Research Operation - Saint Cloud
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Pas Research
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University School Of Medicine
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Not yet recruiting
      • Medical Research Partners- Ammon
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Not yet recruiting
      • Michael W Simon MD, PSC
  • Louisiana
    • Covington, Louisiana, United States, 70433-7237
      • Recruiting
      • MedPharmics - Platinum - PPDS
    • Lafayette, Louisiana, United States, 70508
      • Recruiting
      • MedPharmics - Platinum - PPDS
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Withdrawn
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Memorial Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Recruiting
      • Clinical Research Institute, Inc
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Washington University in St. Louis
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Recruiting
      • Be Well Clinical Studies
  • New York
    • East Syracuse, New York, United States, 13057
      • Not yet recruiting
      • Child Health Care Associates
    • Stony Brook, New York, United States, 11794
      • Not yet recruiting
      • Stony Brook University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Withdrawn
      • Duke Vaccine and Trials Units
    • Wilmington, North Carolina, United States, 28401
      • Not yet recruiting
      • Velocity Clinical Research (Hastings - Nebraska) - PPDS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Withdrawn
      • The Children's Hospital of Philadephia
    • Pittsburgh, Pennsylvania, United States, 15123
      • Recruiting
      • UPMC University Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Recruiting
      • Coastal Pediatric Research
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Not yet recruiting
      • Le Bonheur Childrens Hospital
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • Recruiting
      • South Texas Clinical Research - Corpus Christi
    • Dallas, Texas, United States, 75251
      • Recruiting
      • Cedar Health Research - Dedicated Research Facility
    • Houston, Texas, United States, 77065-5471
      • Recruiting
      • DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS
    • Pearland, Texas, United States, 77584
      • Not yet recruiting
      • Advances In Health Inc
    • Port Lavaca, Texas, United States, 77979
      • Recruiting
      • Victoria Clinical Research Group
  • Utah
    • Layton, Utah, United States, 84041
      • Recruiting
      • Tanner Clinic
    • Layton, Utah, United States, 84041
      • Recruiting
      • Wee Care Pediatrics - Layton Office
    • Roy, Utah, United States, 84067
      • Recruiting
      • Wee Care Pediatrics
    • Syracuse, Utah, United States, 84075
      • Recruiting
      • Wee Care Pediatrics
  • Virginia
    • Burke, Virginia, United States, 22015
      • Recruiting
      • PI-Coor Clinical Research LLC
    • Richmond, Virginia, United States, 23226
      • Recruiting
      • 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	Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)	Up to Day 64 (7 days after each vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)	Up to Day 85 (28 days after each vaccination)
Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs)	Up to Day 422
Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies Against Omicron Variant	Day 85 (28 days after the second vaccination)
Seroresponse Rate Against SARS-CoV-2 Omicron Variant	Day 85 (28 days after the second vaccination)

Secondary Outcome Measures

Outcome Measure	Time Frame
GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1)	Day 85 (28 days after the second vaccination)
GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2)	Day 85 (28 days after the second vaccination)
Seroresponse Rate Against SARS-CoV-2 Omicron Variant (Part 2)	Day 85 (28 days after the second vaccination)
GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2)	Day 85 (28 days after the second vaccination)
Seroresponse Rate Against SARS-CoV-2 Original Strain (Part 2)	Day 85 (28 days after the second vaccination)

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): March 8, 2025
• Study Completion (Estimated): March 8, 2025

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): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

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
• 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