A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age

An Open-Label, Phase 3 Study to Evaluate the Safety and Immunogenicity of mRNA Vaccines for SARS-CoV-2 Variants in Participants Aged 6 Months to < 6 Years

This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to <6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to <6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age (Part 4).

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: mRNA-1273.214; Biological: mRNA-1273.815

Detailed Description

Part 1 will enroll participants aged 6 months to <6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine.

Part 2 will enroll participants aged 6 months to <6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series.

Part 3 will enroll participants aged 6 months to <6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine.

Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to <2 years enrolled in Cohort B (Part 4B).

• Study Type: Interventional
• Enrollment (Estimated): 1860
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Completed
    • Caribbean Medical Research Center
• United States
  • Alabama
    • Bessemer, Alabama, United States, 34020
      • Active, not recruiting
      • Trinity Clinical Research, LLC
  • California
    • Banning, California, United States, 92220
      • Completed
      • Velcocity Clinical Research
    • Montebello, California, United States, 90640
      • Active, not recruiting
      • Sera Collection Research Services
    • Paramount, California, United States, 90723
      • Active, not recruiting
      • Center For Clinical Trials LLC -Paramount
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Completed
      • University of Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Active, not recruiting
      • Meridian Clinical Research
  • Florida
    • Doral, Florida, United States, 33166
      • Recruiting
      • Prohealth Research Center
    • Jacksonville, Florida, United States, 32209
      • Active, not recruiting
      • University of Florida Jacksonville
    • Kissimmee, Florida, United States, 34741
      • Active, not recruiting
      • Kissimmee Clinical Research
    • Miami, Florida, United States, 33125
      • Active, not recruiting
      • Med-Care Research
    • Tampa, Florida, United States, 33612
      • Active, not recruiting
      • University of South Florida
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • IResearch
    • Macon, Georgia, United States, 31210
      • Active, not recruiting
      • Meridian Clinical Research
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Active, not recruiting
      • Velcocity Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Active, not recruiting
      • Lurie Childrens Hospital
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Active, not recruiting
      • Meridian Clinical Research
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Active, not recruiting
      • University of Kentucky
    • Lexington, Kentucky, United States, 40517
      • Completed
      • Michael W. Simon MD, PSC
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Recruiting
      • Velocity Clinical Research - Lafayette - PPDS
    • Metairie, Louisiana, United States, 70006
      • Active, not recruiting
      • MedPharmics
    • Metairie, Louisiana, United States, 70006
      • Recruiting
      • Velocity Clinical Research - Covington - PPDS
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402-2700
      • Recruiting
      • Clinical Research Institute, Inc - CRN - PPDS
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Active, not recruiting
      • University of Missouri Health Care
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Active, not recruiting
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68510
      • Active, not recruiting
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68516
      • Completed
      • Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
    • Omaha, Nebraska, United States, 68114
      • Active, not recruiting
      • Quality Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-3876
      • Recruiting
      • Velocity Clinical Research
    • Albuquerque, New Mexico, United States, 87107-4503
      • Recruiting
      • Velocity Clinical Research
  • New York
    • Binghamton, New York, United States, 13901
      • Active, not recruiting
      • Meridian Clinical Research
    • E. Amherst, New York, United States, 14051
      • Active, not recruiting
      • WellNow Urgent Care Clinical Research
    • East Syracuse, New York, United States, 13057
      • Active, not recruiting
      • Child Healthcare Associates - East Syracuse
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Active, not recruiting
      • Lynn Health Science Institute
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Recruiting
      • Velcocity Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Active, not recruiting
      • Coastal Pediatric Associates
    • Charleston, South Carolina, United States, 29414
      • Completed
      • Meridian Clinical Research
    • Charleston, South Carolina, United States, 29425
      • Active, not recruiting
      • MUSC
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Active, not recruiting
      • Le Bonheur Childrens Hospital
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Active, not recruiting
      • Velcocity Clinical Research
    • Edinburg, Texas, United States, 78539
      • Completed
      • BRCR Global Texas
    • Frisco, Texas, United States, 75033
      • Active, not recruiting
      • Village Health Partners - Frisco Medical Village
    • Houston, Texas, United States, 77008
      • Active, not recruiting
      • Ventavia Research Group
    • Houston, Texas, United States, 77065
      • Active, not recruiting
      • Cyfair Clinical Reseach Center
    • Houston, Texas, United States, 77081
      • Active, not recruiting
      • Texas Center for Drug Development
    • Victoria, Texas, United States, 77901
      • Completed
      • Victoria Clinical Research Group
  • Virginia
    • Burke, Virginia, United States, 22015
      • Active, not recruiting
      • Pi Coor Clinical Research Llc
    • Richmond, Virginia, United States, 23226
      • Recruiting
      • Clinical Research Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The participant is 6 months to <6 years for Parts 1, 2, and 3; 2 years to <5 years for Part 4A; and 6 months to <2 years for Part 4B at the time of consent (Screening Visit). Note: for Part 1, participant must be at least 6 months old and must not have reached 6 years of age at the time of administration of first dose. For Part 4B, the participant must be at least 6 months old and must not have reached 2 years of age at the time of administration of first dose.
• If the participant has a chronic disease (that is, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion. Stable diseases are those which have had no change in their status or in the medications required to control them in the 6 months prior to Screening Visit. Note: a change in medication for dose optimization (that is, insulin dose changes, adjustments for age-related weight gain), change within class of medication, or reduction in dose are not considered signs of instability.
• In the investigator's opinion, the parent(s)/legally authorized representative(s) (LAR[s]) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures and provide written informed consent.
• The participant is 2 years or older and has a body mass index (BMI) at or above the second percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit.

OR

• The participant is less than 2 years of age and the participant's height and weight are both at or above the second percentile according to WHO Child Growth Standards at the Screening Visit.

Special inclusion criteria for participants aged 6 months to < 12 months:

• The participant was born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).

Inclusion criteria for Part 2:

• The participant must have received 2 doses of mRNA-1273, approximately 28 to 35 days apart, as 25-μg primary series, and second dose was given at least 4 months prior to enrollment.

Inclusion criteria for Part 3 only:

- The participant must have received an age-appropriate immunization series of an authorized/approved COVID-19 vaccine, with the last dose given at least 4 months prior to enrolment (Previous vaccines NOT allowed are: XBB.1.5-containing formulation).

Exclusion Criteria:

• Has a known history of SARS-CoV-2 infection (that is, reported AE of COVID-19 or asymptomatic SARS-CoV-2 infection during Study mRNA-1273-P204 at the time of rollover into mRNA-1273-P306 or during Part 1 at the time of rollover into Part 3) in the 90 days prior to dosing in this study.
• Is acutely ill or febrile 24 hours prior to or at the Screening Visit. Fever is defined as a body temperature ≥ 38.0°Celsius (C)/≥ 100.4°Fahrenheit (F). 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.
• For Parts 1 and 4, participant has previously been administered an investigational or approved CoV (that is, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome coronavirus [MERS-CoV]) vaccine. For Part 2, participant who received any approved/investigational CoV vaccine are ineligible to participate except for those who received mRNA-1273 (prototype) vaccine.
• Has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (including receipt of SARS-CoV-2 monoclonal antibodies for prophylaxis or treatment) within 90 days prior to enrollment.
• 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 a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG] or immediate allergic reaction of any severity to polysorbate).
• Has a medical or psychiatric 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.

• Has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically the following:

  • Congenital or acquired immunodeficiency, other than well-controlled HIV infection.
  • Chronic hepatitis or suspected active hepatitis
  • A bleeding disorder that is considered a contraindication to IM injection or phlebotomy
  • Dermatologic conditions that could affect local solicited AR assessments
  • Any prior diagnosis of malignancy (excluding nonmelanoma skin cancer)

• Has received the following:

  • Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to study vaccination or plans to receive such a vaccine through 14 days following study vaccination.

Note: This excludes influenza vaccine that may be given anytime, but ideally at least 7 days before study dose. If a participant receives an influenza vaccine, this should be captured within the concomitant medication electronic case report form (eCRF).

• Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥ 10 mg/day prednisone equivalent, if participant weighs >10 kg). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids, and palivizumab are allowed.
• Intravenous (IV) or subcutaneous (SC) blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1273.214 (Part 1); Participants who have not been previously vaccinated against SARS-CoV-2, will receive 2 intramuscular (IM) injections of mRNA-1273.214 vaccine on Day 1 and Day 29.	Biological: mRNA-1273.214; Sterile liquid for injection
Experimental: mRNA-1273.214 (Part 2); Participants who have previously been vaccinated with a mRNA-1273 primary series, will receive a single IM BD of mRNA-1273.214 vaccine at least 4 months after completion of the mRNA-1273 primary series.	Biological: mRNA-1273.214; Sterile liquid for injection
Experimental: mRNA-1273.815 (Part 3); Participants who have previously been vaccinated with an authorized/approved COVID-19 vaccine, will receive a single IM BD of mRNA-1273.815 vaccine on BD Day 1, at least 4 months after the last dose of a COVID-19 vaccine.	Biological: mRNA-1273.815; Sterile liquid for injection
Experimental: mRNA-1273.815 (Part 4); Participants in Part 4 Cohort A will receive a single IM injection of mRNA-1273.815 vaccine on Day 1. Participants in Part 4 Cohort B will receive IM injections of mRNA-1273.815 vaccine on Day 1 and Day 29.	Biological: mRNA-1273.815; Sterile liquid for injection

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 8 (7 days post-vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)	Up to Day 29 (28 days after each injection)
Number of Participants with Medically-Attended AEs (MAAEs)	Up to Day 394 (12 months after last dose)
Number of Participants with Serious AEs (SAEs)	Up to Day 394 (12 months after last dose)
Number of Participants with Adverse Events of Special Interest (AESI)	Up to Day 394 (12 months after last dose)
Number of Participants with AEs Leading to Withdrawal	Up to Day 394 (12 months after last dose)
Geometric Mean (GM) of the Serum Antibody (Ab) Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 57	Day 57
GM of the Serum Ab Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 29	Day 29
Seroresponse Rate (SRR) against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration	Day 29
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration	Up to Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection	Day 57
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection	Up to Day 57
SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection	Up to Day 57

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): October 27, 2025
• Study Completion (Estimated): October 27, 2025

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Coronavirus disease 2019
• Other Study ID Numbers: mRNA-1273-P306

Drug and device information, study documents

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