Phase
Condition
Sars-cov-2
Treatment
mRNA-1273.815
mRNA-1273.214
Clinical Study ID
Ages 6-5 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
AES - AS - Glenny Corp. S.A. Buenos Aires
Caba, Ciudad Autónoma De Buenos Aires C1430CKE
ArgentinaActive - Recruiting
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1426BOS
ArgentinaActive - Recruiting
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Tucumán T4000CAM
ArgentinaActive - Recruiting
Consultorios Médicos Dr. Doreski - PPDS
Ciudad Autónoma De Buenos Aires, C1426ABP
ArgentinaActive - Recruiting
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
Santiago, Region Metropolitana 8320000
ChileActive - Recruiting
AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín
Medellin, Antioquia 050021
ColombiaActive - Recruiting
Clínica de Costa S.A.S
Barranquilla, Atlántico 80020
ColombiaActive - Recruiting
Clínica de la Costa S.A.S- Sede Cartagena
Cartagena, Bolivar 130011
ColombiaActive - Recruiting
Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul
Aguazul, Casanare 856010
ColombiaActive - Recruiting
Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED
Yopal, Casanare 850001
ColombiaActive - Recruiting
Policlínico Social del Norte
Bogotá, Cundinamarca 110131
ColombiaActive - Recruiting
AES- AS- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogotá
Bogotá, Distrito Capital De Bogotá 110221
ColombiaActive - Recruiting
Centro de Atención e Investigación Médica S.A.S.- CAIMED - S.A.S. Sede Acacias
Acacias, Meta 507001
ColombiaActive - Recruiting
Caimed Dominicana S.A.S - CAIMED - PPDS
Santo Domingo De Guzmán, Distrito NacionalSanto Domingo 11903
Dominican RepublicActive - Recruiting
Registrum- La Altagracia
Higüey, La Altagracia 23000
Dominican RepublicActive - Recruiting
Hospital Materno Infantil San Lorenzo de Los Mina
Santo Domingo Este, Santo Domingo 11901
Dominican RepublicActive - Recruiting
Hospital General Regional Dr. Marcelino Velez Santana
Santo Domingo Iesta, Santo Domingo 11117
Dominican RepublicActive - Recruiting
Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B
Santo Domingo, 10305
Dominican RepublicActive - Recruiting
CAENSA Clinical Trial
Panama,
PanamaActive - Recruiting
CEVAXIN 24 de diciembre - PPDS
Panama,
PanamaActive - Recruiting
CEVAXIN Avenida México - PPDS
Panama,
PanamaActive - Recruiting
CEVAXIN Chorrera - PPDS
Panama,
PanamaActive - Recruiting
Centro De Vacunacion Internacional, S.A. - David - Cevaxin - PPDS
Panama,
PanamaActive - Recruiting
Curaex Clinical Trial
Panama,
PanamaActive - Recruiting
Instituto de Investigaciones Científicas y Servicios de Alta Tecnología Asociación de Interés Panama
Panama,
PanamaActive - Recruiting
Caribbean Medical Research Center
San Juan, 00918
Puerto RicoActive - Recruiting
Trinity Clinical Research, LLC
Bessemer, Alabama 34020
United StatesActive - Recruiting
Velcocity Clinical Research
Banning, California 92220
United StatesCompleted
Sera Collection Research Services
Montebello, California 90640
United StatesActive - Recruiting
Center For Clinical Trials LLC -Paramount
Paramount, California 90723
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesCompleted
Meridian Clinical Research
Washington, District of Columbia 20016
United StatesSite Not Available
Prohealth Research Center
Doral, Florida 33166
United StatesActive - Recruiting
University of Florida Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
Kissimmee Clinical Research
Kissimmee, Florida 34741
United StatesActive - Recruiting
Med-Care Research
Miami, Florida 33125
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33612
United StatesActive - Recruiting
IResearch
Decatur, Georgia 30030
United StatesActive - Recruiting
Meridian Clinical Research
Macon, Georgia 31210
United StatesActive - Recruiting
Velcocity Clinical Research
Meridian, Idaho 83642
United StatesActive - Recruiting
Lurie Childrens Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Meridian Clinical Research
Overland Park, Kansas 66210
United StatesActive - Recruiting
Michael W. Simon MD, PSC
Lexington, Kentucky 40517
United StatesCompleted
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Velocity Clinical Research - Lafayette - PPDS
Lafayette, Louisiana 70508
United StatesActive - Recruiting
MedPharmics
Metairie, Louisiana 70006
United StatesSite Not Available
Velocity Clinical Research - Covington - PPDS
Metairie, Louisiana 70006
United StatesActive - Recruiting
Clinical Research Institute
Minneapolis, Minnesota 55402
United StatesActive - Recruiting
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota 55402-2700
United StatesSite Not Available
University of Missouri Health Care
Columbia, Missouri 65212
United StatesActive - Recruiting
Meridian Clinical Research
Hastings, Nebraska 68901
United StatesSite Not Available
Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
Lincoln, Nebraska 68516
United StatesCompleted
Meridian Clinical Research
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Quality Clinical Research
Omaha, Nebraska 68114
United StatesSite Not Available
Velocity Clinical Research
Albuquerque, New Mexico 87102
United StatesActive - Recruiting
Meridian Clinical Research
Binghamton, New York 13901
United StatesActive - Recruiting
WellNow Urgent Care Clinical Research
E. Amherst, New York 14051
United StatesSite Not Available
Child Healthcare Associates - East Syracuse
East Syracuse, New York 13057
United StatesActive - Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Velcocity Clinical Research
East Greenwich, Rhode Island 02818
United StatesActive - Recruiting
Coastal Pediatric Associates
Charleston, South Carolina 29414
United StatesSite Not Available
MUSC
Charleston, South Carolina 29425
United StatesSite Not Available
Meridian Clinical Research
Charleston, South Carolina 29414
United StatesCompleted
Le Bonheur Childrens Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
Velocity Clinical Research Austin
Austin, Texas 78759
United StatesActive - Recruiting
REX Clinical Trials, LLC Beaumont
Beaumont, Texas 77701-3739
United StatesActive - Recruiting
Velcocity Clinical Research
Cedar Park, Texas 78613
United StatesSite Not Available
BRCR Global Texas
Edinburg, Texas 78539
United StatesCompleted
Village Health Partners - Frisco Medical Village
Frisco, Texas 75033
United StatesActive - Recruiting
Cyfair Clinical Reseach Center
Houston, Texas 77065
United StatesActive - Recruiting
Texas Center for Drug Development
Houston, Texas 77081
United StatesActive - Recruiting
Ventavia Research Group
Houston, Texas 77008
United StatesActive - Recruiting
Victoria Clinical Research Group
Victoria, Texas 77901
United StatesCompleted
PI Coor Clinical Research LLC
Burke, Virginia 22015
United StatesActive - Recruiting
Clinical Research Partners
Richmond, Virginia 23226
United StatesActive - Recruiting
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