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

Last updated: March 7, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Sars-cov-2

Treatment

mRNA-1273.815

mRNA-1273.214

Clinical Study ID

NCT05436834
mRNA-1273-P306
  • Ages 6-5
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant is 6 months to <6 years for Parts 1, 2, and 3; 2 years to <5 yearsfor Part 4A; and 6 months to <2 years for Part 4B at the time of consent (ScreeningVisit). Note: for Part 1, participant must be at least 6 months old and must nothave 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 yearsof age at the time of administration of first dose.

  • If the participant has a chronic disease (that is, asthma, diabetes mellitus, cysticfibrosis, human immunodeficiency virus [HIV] infection), the disease should bestable, per investigator assessment, so that the participant can be consideredeligible for inclusion. Stable diseases are those which have had no change in theirstatus or in the medications required to control them in the 6 months prior toScreening Visit. Note: a change in medication for dose optimization (that is,insulin dose changes, adjustments for age-related weight gain), change within classof 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 withprotocol-mandated follow-up, including all procedures and provide written informedconsent.

  • The participant is 2 years or older and has a body mass index (BMI) at or above thesecond percentile according to World Health Organization (WHO) Child GrowthStandards at the Screening Visit.

OR

  • The participant is less than 2 years of age and the participant's height and weightare both at or above the second percentile according to WHO Child Growth Standardsat 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 birthweight of 2.5 kilograms (kg).

Inclusion criteria for Part 2:

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

Inclusion criteria for Part 3 only:

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

Exclusion

Exclusion Criteria:

  • Has a known history of SARS-CoV-2 infection (that is, reported AE of COVID-19 orasymptomatic SARS-CoV-2 infection during Study mRNA-1273-P204 at the time ofrollover 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 isdefined as a body temperature ≥ 38.0°Celsius (C)/≥ 100.4°Fahrenheit (F).Participants who meet this criterion may have visits rescheduled within the relevantstudy visit windows. Afebrile participants with minor illnesses can be enrolled atthe discretion of the investigator.

  • For Parts 1 and 4, participant has previously been administered an investigationalor approved CoV (that is, SARS-CoV-2, SARS-CoV, Middle East respiratory syndromecoronavirus [MERS-CoV]) vaccine. For Part 2, participant who received anyapproved/investigational CoV vaccine are ineligible to participate except for thosewho received mRNA-1273 (prototype) vaccine.

  • Has undergone treatment with investigational or approved agents for prophylaxisagainst COVID-19 (including receipt of SARS-CoV-2 monoclonal antibodies forprophylaxis 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 allergicreaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any ofits components (including polyethylene glycol [PEG] or immediate allergic reactionof any severity to polysorbate).

  • Has a medical or psychiatric condition that, according to the investigator'sjudgment, may pose additional risk as a result of participation, interfere withsafety 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, specificallythe following:

  • Congenital or acquired immunodeficiency, other than well-controlled HIVinfection.

  • Chronic hepatitis or suspected active hepatitis

  • A bleeding disorder that is considered a contraindication to IM injection orphlebotomy

  • 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 daysprior to study vaccination or plans to receive such a vaccine through 14 daysfollowing 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 6months 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 thiscriterion 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 Design

Total Participants: 1860
Treatment Group(s): 2
Primary Treatment: mRNA-1273.815
Phase: 3
Study Start date:
June 21, 2022
Estimated Completion Date:
October 27, 2025

Study 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).

Connect with a study center

  • AES - AS - Glenny Corp. S.A. Buenos Aires

    Caba, Ciudad Autónoma De Buenos Aires C1430CKE
    Argentina

    Active - Recruiting

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1426BOS
    Argentina

    Active - Recruiting

  • AES - AS - Clinica Mayo de Urgencias

    San Miguel de Tucumán, Tucumán T4000CAM
    Argentina

    Active - Recruiting

  • Consultorios Médicos Dr. Doreski - PPDS

    Ciudad Autónoma De Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)

    Santiago, Region Metropolitana 8320000
    Chile

    Active - Recruiting

  • AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín

    Medellin, Antioquia 050021
    Colombia

    Active - Recruiting

  • Clínica de Costa S.A.S

    Barranquilla, Atlántico 80020
    Colombia

    Active - Recruiting

  • Clínica de la Costa S.A.S- Sede Cartagena

    Cartagena, Bolivar 130011
    Colombia

    Active - Recruiting

  • Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul

    Aguazul, Casanare 856010
    Colombia

    Active - Recruiting

  • Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED

    Yopal, Casanare 850001
    Colombia

    Active - Recruiting

  • Policlínico Social del Norte

    Bogotá, Cundinamarca 110131
    Colombia

    Active - Recruiting

  • AES- AS- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogotá

    Bogotá, Distrito Capital De Bogotá 110221
    Colombia

    Active - Recruiting

  • Centro de Atención e Investigación Médica S.A.S.- CAIMED - S.A.S. Sede Acacias

    Acacias, Meta 507001
    Colombia

    Active - Recruiting

  • Caimed Dominicana S.A.S - CAIMED - PPDS

    Santo Domingo De Guzmán, Distrito NacionalSanto Domingo 11903
    Dominican Republic

    Active - Recruiting

  • Registrum- La Altagracia

    Higüey, La Altagracia 23000
    Dominican Republic

    Active - Recruiting

  • Hospital Materno Infantil San Lorenzo de Los Mina

    Santo Domingo Este, Santo Domingo 11901
    Dominican Republic

    Active - Recruiting

  • Hospital General Regional Dr. Marcelino Velez Santana

    Santo Domingo Iesta, Santo Domingo 11117
    Dominican Republic

    Active - Recruiting

  • Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B

    Santo Domingo, 10305
    Dominican Republic

    Active - Recruiting

  • CAENSA Clinical Trial

    Panama,
    Panama

    Active - Recruiting

  • CEVAXIN 24 de diciembre - PPDS

    Panama,
    Panama

    Active - Recruiting

  • CEVAXIN Avenida México - PPDS

    Panama,
    Panama

    Active - Recruiting

  • CEVAXIN Chorrera - PPDS

    Panama,
    Panama

    Active - Recruiting

  • Centro De Vacunacion Internacional, S.A. - David - Cevaxin - PPDS

    Panama,
    Panama

    Active - Recruiting

  • Curaex Clinical Trial

    Panama,
    Panama

    Active - Recruiting

  • Instituto de Investigaciones Científicas y Servicios de Alta Tecnología Asociación de Interés Panama

    Panama,
    Panama

    Active - Recruiting

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Trinity Clinical Research, LLC

    Bessemer, Alabama 34020
    United States

    Active - Recruiting

  • Velcocity Clinical Research

    Banning, California 92220
    United States

    Completed

  • Sera Collection Research Services

    Montebello, California 90640
    United States

    Active - Recruiting

  • Center For Clinical Trials LLC -Paramount

    Paramount, California 90723
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Completed

  • Meridian Clinical Research

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Prohealth Research Center

    Doral, Florida 33166
    United States

    Active - Recruiting

  • University of Florida Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Kissimmee Clinical Research

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Med-Care Research

    Miami, Florida 33125
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • IResearch

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Macon, Georgia 31210
    United States

    Active - Recruiting

  • Velcocity Clinical Research

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Lurie Childrens Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Meridian Clinical Research

    Overland Park, Kansas 66210
    United States

    Active - Recruiting

  • Michael W. Simon MD, PSC

    Lexington, Kentucky 40517
    United States

    Completed

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Velocity Clinical Research - Lafayette - PPDS

    Lafayette, Louisiana 70508
    United States

    Active - Recruiting

  • MedPharmics

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Velocity Clinical Research - Covington - PPDS

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

  • Clinical Research Institute, Inc - CRN - PPDS

    Minneapolis, Minnesota 55402-2700
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS

    Lincoln, Nebraska 68516
    United States

    Completed

  • Meridian Clinical Research

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Velocity Clinical Research

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Binghamton, New York 13901
    United States

    Active - Recruiting

  • WellNow Urgent Care Clinical Research

    E. Amherst, New York 14051
    United States

    Site Not Available

  • Child Healthcare Associates - East Syracuse

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Velcocity Clinical Research

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Coastal Pediatric Associates

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Meridian Clinical Research

    Charleston, South Carolina 29414
    United States

    Completed

  • Le Bonheur Childrens Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Velocity Clinical Research Austin

    Austin, Texas 78759
    United States

    Active - Recruiting

  • REX Clinical Trials, LLC Beaumont

    Beaumont, Texas 77701-3739
    United States

    Active - Recruiting

  • Velcocity Clinical Research

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • BRCR Global Texas

    Edinburg, Texas 78539
    United States

    Completed

  • Village Health Partners - Frisco Medical Village

    Frisco, Texas 75033
    United States

    Active - Recruiting

  • Cyfair Clinical Reseach Center

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Texas Center for Drug Development

    Houston, Texas 77081
    United States

    Active - Recruiting

  • Ventavia Research Group

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Victoria Clinical Research Group

    Victoria, Texas 77901
    United States

    Completed

  • PI Coor Clinical Research LLC

    Burke, Virginia 22015
    United States

    Active - Recruiting

  • Clinical Research Partners

    Richmond, Virginia 23226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.