Official Title
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
Brief Summary

This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine forsevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs)in participants aged 6 months to

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).

Recruiting
SARS-CoV-2

Biological: mRNA-1273.214

Sterile liquid for injection

Biological: mRNA-1273.815

Sterile liquid for injection

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 6 Months ~ Maximum: 5 Years
Countries
Argentina
Chile
Colombia
Dominican Republic
Panama
Puerto Rico
United States
Locations

Trinity Clinical Research, LLC
Bessemer, Alabama, United States

Velcocity Clinical Research
Banning, California, United States

Sera Collection Research Services
Montebello, California, United States

Center For Clinical Trials LLC -Paramount
Paramount, California, United States

University of Colorado
Aurora, Colorado, United States

Meridian Clinical Research
Washington, District of Columbia, United States

Prohealth Research Center
Doral, Florida, United States

University of Florida Jacksonville
Jacksonville, Florida, United States

Kissimmee Clinical Research
Kissimmee, Florida, United States

Med-Care Research
Miami, Florida, United States

University of South Florida
Tampa, Florida, United States

IResearch
Decatur, Georgia, United States

Meridian Clinical Research
Macon, Georgia, United States

Velcocity Clinical Research
Meridian, Idaho, United States

Lurie Childrens Hospital
Chicago, Illinois, United States

Meridian Clinical Research
Overland Park, Kansas, United States

Michael W. Simon MD, PSC
Lexington, Kentucky, United States

University of Kentucky
Lexington, Kentucky, United States

Velocity Clinical Research - Lafayette - PPDS
Lafayette, Louisiana, United States

MedPharmics
Metairie, Louisiana, United States

Velocity Clinical Research - Covington - PPDS
Metairie, Louisiana, United States

Clinical Research Institute
Minneapolis, Minnesota, United States

University of Missouri Health Care
Columbia, Missouri, United States

Meridian Clinical Research
Hastings, Nebraska, United States

Meridian Clinical Research
Lincoln, Nebraska, United States

Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
Lincoln, Nebraska, United States

Quality Clinical Research
Omaha, Nebraska, United States

Velocity Clinical Research
Albuquerque, New Mexico, United States

Meridian Clinical Research
Binghamton, New York, United States

WellNow Urgent Care Clinical Research
E. Amherst, New York, United States

Child Healthcare Associates - East Syracuse
East Syracuse, New York, United States

Lynn Health Science Institute
Oklahoma City, Oklahoma, United States

Velcocity Clinical Research
East Greenwich, Rhode Island, United States

Coastal Pediatric Associates
Charleston, South Carolina, United States

Meridian Clinical Research
Charleston, South Carolina, United States

MUSC
Charleston, South Carolina, United States

Le Bonheur Childrens Hospital
Memphis, Tennessee, United States

Velocity Clinical Research Austin
Austin, Texas, United States

REX Clinical Trials, LLC Beaumont
Beaumont, Texas, United States

Velcocity Clinical Research
Cedar Park, Texas, United States

BRCR Global Texas
Edinburg, Texas, United States

Village Health Partners - Frisco Medical Village
Frisco, Texas, United States

Ventavia Research Group
Houston, Texas, United States

Cyfair Clinical Reseach Center
Houston, Texas, United States

Texas Center for Drug Development
Houston, Texas, United States

Victoria Clinical Research Group
Victoria, Texas, United States

PI Coor Clinical Research LLC
Burke, Virginia, United States

Clinical Research Partners
Richmond, Virginia, United States

AES - AS - Glenny Corp. S.A. Buenos Aires
Caba, Ciudad Autónoma De Buenos Aires, Argentina

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Tucumán, Argentina

Consultorios Médicos Dr. Doreski - PPDS
Ciudad Autónoma De Buenos Aires, Argentina

Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
Santiago, Region Metropolitana, Chile

AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín
Medellin, Antioquia, Colombia

Clínica de Costa S.A.S
Barranquilla, Atlántico, Colombia

Clínica de la Costa S.A.S- Sede Cartagena
Cartagena, Bolivar, Colombia

Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul
Aguazul, Casanare, Colombia

Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED
Yopal, Casanare, Colombia

Policlínico Social del Norte
Bogotá, Cundinamarca, Colombia

AES- AS- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogotá
Bogotá, Distrito Capital De Bogotá, Colombia

Centro de Atención e Investigación Médica S.A.S.- CAIMED - S.A.S. Sede Acacias
Acacias, Meta, Colombia

Caimed Dominicana S.A.S - CAIMED - PPDS
Santo Domingo De Guzmán, Distrito NacionalSanto Domingo, Dominican Republic

Registrum- La Altagracia
Higüey, La Altagracia, Dominican Republic

Hospital Materno Infantil San Lorenzo de Los Mina
Santo Domingo Este, Santo Domingo, Dominican Republic

Hospital General Regional Dr. Marcelino Velez Santana
Santo Domingo Iesta, Santo Domingo, Dominican Republic

Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B
Santo Domingo, Dominican Republic

CAENSA Clinical Trial
Panama, Panama

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

CEVAXIN 24 de diciembre - PPDS
Panama, Panama

CEVAXIN Avenida México - PPDS
Panama, Panama

CEVAXIN Chorrera - PPDS
Panama, Panama

Curaex Clinical Trial
Panama, Panama

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

Caribbean Medical Research Center
San Juan, Puerto Rico

Contacts

Moderna Clinical Trials Support Center
1-877-777-7187
clinicaltrials@modernatx.com

Not Provided

ModernaTX, Inc.
NCT Number
Keywords
Coronavirus disease 2019
Covid-19