Phase
Condition
Sars-cov-2
Covid-19
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 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
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, Buenos Aires F.D. 3433955 C1430CKE
ArgentinaSite Not Available
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
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires 3435910, Ciudad Autónoma de BuenosAires C1426BOS
ArgentinaSite Not Available
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Tucumán T4000CAM
ArgentinaSite Not Available
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000CAM
ArgentinaSite Not Available
Consultorios Médicos Dr. Doreski - PPDS
Buenos Aires 3435910, C1426ABP
ArgentinaSite Not Available
Consultorios Médicos Dr. Doreski - PPDS
Ciudad Autónoma De Buenos Aires, C1426ABP
ArgentinaSite Not Available
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
Santiago, Region Metropolitana 8320000
ChileSite Not Available
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
Santiago 3871336, Santiago Metropolitan 3873544 8320000
ChileSite Not Available
AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín
Medellin, Antioquia 050021
ColombiaSite Not Available
AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín
Medellín 3674962, Antioquia 3689815 050021
ColombiaSite Not Available
Clínica de Costa S.A.S
Barranquilla, Atlántico 80020
ColombiaSite Not Available
Clínica de Costa S.A.S
Barranquilla 3689147, Atlántico 3689436 80020
ColombiaSite Not Available
AES- AS- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogotá
Bogotá 3688689, Bogota D.C. 3688685 110221
ColombiaSite Not Available
Clínica de la Costa S.A.S- Sede Cartagena
Cartagena, Bolivar 130011
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul
Aguazul, Casanare 856010
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED
Yopal, Casanare 850001
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul
Aguazul 3690316, Casanare Department 3687173 856010
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED
Yopal 3665688, Casanare Department 3687173 850001
ColombiaSite Not Available
Policlínico Social del Norte
Bogotá, Cundinamarca 3685413 110131
ColombiaSite Not Available
Clínica de la Costa S.A.S- Sede Cartagena
Cartagena 3687238, Departamento de Bolívar 3688650 130011
ColombiaSite Not Available
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
ColombiaSite Not Available
Centro de Atención e Investigación Médica S.A.S.- CAIMED - S.A.S. Sede Acacias
Acacías 3690577, Meta Department 3674810 507001
ColombiaSite Not Available
Caimed Dominicana S.A.S - CAIMED - PPDS
Santo Domingo 3492908, Distrito NacionalSanto Domingo 11903
Dominican RepublicSite Not Available
Caimed Dominicana S.A.S - CAIMED - PPDS
Santo Domingo De Guzmán, Distrito NacionalSanto Domingo 11903
Dominican RepublicSite Not Available
Registrum- La Altagracia
Higüey, La Altagracia 23000
Dominican RepublicSite Not Available
Registrum- La Altagracia
Salvaleón de Higüey 3493240, La Altagracia Province 3503706 23000
Dominican RepublicSite Not Available
Hospital Materno Infantil San Lorenzo de Los Mina
Santo Domingo Este, Santo Domingo 11901
Dominican RepublicSite Not Available
Hospital Materno Infantil San Lorenzo de Los Mina
Santo Domingo Este 8601412, Santo Domingo Province 6201373 11901
Dominican RepublicSite Not Available
Hospital General Regional Dr. Marcelino Velez Santana
Santo Domingo Iesta, Santo Domingo Province 6201373 11117
Dominican RepublicSite Not Available
Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B
Santo Domingo, 10305
Dominican RepublicSite Not Available
Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B
Santo Domingo 3492908, 10305
Dominican RepublicSite Not Available
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,
PanamaSite Not Available
CAENSA Clinical Trial
Panama City 3703443,
PanamaSite Not Available
CEVAXIN 24 de diciembre - PPDS
Panama City 3703443,
PanamaSite Not Available
CEVAXIN Avenida México - PPDS
Panama City 3703443,
PanamaSite Not Available
CEVAXIN Chorrera - PPDS
Panama City 3703443,
PanamaSite Not Available
Centro De Vacunacion Internacional, S.A. - David - Cevaxin - PPDS
Panama City 3703443,
PanamaSite Not Available
Curaex Clinical Trial
Panama City 3703443,
PanamaSite Not Available
Instituto de Investigaciones Científicas y Servicios de Alta Tecnología Asociación de Interés Panama
Panama City 3703443,
PanamaSite Not Available
Caribbean Medical Research Center
San Juan, 00918
Puerto RicoSite Not Available
Caribbean Medical Research Center
San Juan 4568127, 00918
Puerto RicoSite Not Available
Trinity Clinical Research, LLC
Bessemer, Alabama 34020
United StatesSite Not Available
Trinity Clinical Research, LLC
Bessemer 4048023, Alabama 4829764 34020
United StatesSite Not Available
Velcocity Clinical Research
Banning, California 92220
United StatesSite Not Available
Sera Collection Research Services
Montebello, California 90640
United StatesSite Not Available
Center For Clinical Trials LLC -Paramount
Paramount, California 90723
United StatesSite Not Available
Velcocity Clinical Research
Banning 5326032, California 5332921 92220
United StatesSite Not Available
Sera Collection Research Services
Montebello 5374322, California 5332921 90640
United StatesSite Not Available
Center For Clinical Trials LLC -Paramount
Paramount 5381110, California 5332921 90723
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Meridian Clinical Research
Washington, District of Columbia 20016
United StatesSite Not Available
Meridian Clinical Research
Washington D.C. 4140963, District of Columbia 4138106 20016
United StatesSite Not Available
Prohealth Research Center
Doral, Florida 33166
United StatesSite Not Available
University of Florida Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Kissimmee Clinical Research
Kissimmee, Florida 34741
United StatesSite Not Available
Med-Care Research
Miami, Florida 33125
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Prohealth Research Center
Doral 4153471, Florida 4155751 33166
United StatesSite Not Available
University of Florida Jacksonville
Jacksonville 4160021, Florida 4155751 32209
United StatesSite Not Available
Kissimmee Clinical Research
Kissimmee 4160983, Florida 4155751 34741
United StatesSite Not Available
Med-Care Research
Miami 4164138, Florida 4155751 33125
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
IResearch
Decatur, Georgia 30030
United StatesSite Not Available
Meridian Clinical Research
Macon, Georgia 31210
United StatesSite Not Available
IResearch
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Meridian Clinical Research
Macon 4207400, Georgia 4197000 31210
United StatesSite Not Available
Velcocity Clinical Research
Meridian, Idaho 83642
United StatesSite Not Available
Velcocity Clinical Research
Meridian 5600685, Idaho 5596512 83642
United StatesSite Not Available
Lurie Childrens Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Lurie Childrens Hospital
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Meridian Clinical Research
Overland Park, Kansas 66210
United StatesSite Not Available
Meridian Clinical Research
Overland Park 4276873, Kansas 4273857 66210
United StatesSite Not Available
Michael W. Simon MD, PSC
Lexington, Kentucky 40517
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Michael W. Simon MD, PSC
Lexington 4297983, Kentucky 6254925 40517
United StatesSite Not Available
University of Kentucky
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
Velocity Clinical Research - Lafayette - PPDS
Lafayette, Louisiana 70508
United StatesSite Not Available
MedPharmics
Metairie, Louisiana 70006
United StatesSite Not Available
Velocity Clinical Research - Covington - PPDS
Metairie, Louisiana 70006
United StatesSite Not Available
Velocity Clinical Research - Lafayette - PPDS
Lafayette 4330145, Louisiana 4331987 70508
United StatesSite Not Available
MedPharmics
Metairie 4333177, Louisiana 4331987 70006
United StatesSite Not Available
Velocity Clinical Research - Covington - PPDS
Metairie 4333177, Louisiana 4331987 70006
United StatesSite Not Available
Clinical Research Institute
Minneapolis, Minnesota 55402
United StatesActive - Recruiting
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota 55402-2700
United StatesSite Not Available
Clinical Research Institute
Minneapolis 5037649, Minnesota 5037779 55402
United StatesSite Not Available
University of Missouri Health Care
Columbia, Missouri 65212
United StatesSite Not Available
University of Missouri Health Care
Columbia 4381982, Missouri 4398678 65212
United StatesSite Not Available
Meridian Clinical Research
Hastings, Nebraska 68901
United StatesSite Not Available
Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
Lincoln, Nebraska 68516
United StatesSite Not Available
Meridian Clinical Research
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Quality Clinical Research
Omaha, Nebraska 68114
United StatesSite Not Available
Meridian Clinical Research
Hastings 5069802, Nebraska 5073708 68901
United StatesSite Not Available
Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
Lincoln 5072006, Nebraska 5073708 68516
United StatesSite Not Available
Meridian Clinical Research
Lincoln 5072006, Nebraska 5073708 68510
United StatesSite Not Available
Quality Clinical Research
Omaha 5074472, Nebraska 5073708 68114
United StatesSite Not Available
Velocity Clinical Research
Albuquerque, New Mexico 87107-4503
United StatesSite Not Available
Velocity Clinical Research
Albuquerque 5454711, New Mexico 5481136 87102
United StatesSite Not Available
Meridian Clinical Research
Binghamton, New York 13901
United StatesSite Not Available
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 StatesSite Not Available
Meridian Clinical Research
Binghamton 5109177, New York 5128638 13901
United StatesSite Not Available
WellNow Urgent Care Clinical Research
East Amherst 5115699, New York 5128638 14051
United StatesSite Not Available
Child Healthcare Associates - East Syracuse
East Syracuse 5116079, New York 5128638 13057
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City 4544349, Oklahoma 4544379 73112
United StatesSite Not Available
Velcocity Clinical Research
East Greenwich, Rhode Island 02818
United StatesSite Not Available
Velcocity Clinical Research
East Greenwich 5221875, Rhode Island 5224323 02818
United StatesSite Not Available
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 StatesSite Not Available
Coastal Pediatric Associates
Charleston 4574324, South Carolina 4597040 29414
United StatesSite Not Available
MUSC
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Meridian Clinical Research
Charleston 4574324, South Carolina 4597040 29414
United StatesSite Not Available
Le Bonheur Childrens Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
Le Bonheur Childrens Hospital
Memphis 4641239, Tennessee 4662168 38105
United StatesSite Not Available
Velocity Clinical Research Austin
Austin, Texas 78759
United StatesSite Not Available
REX Clinical Trials, LLC Beaumont
Beaumont, Texas 77701-3739
United StatesSite Not Available
Velcocity Clinical Research
Cedar Park, Texas 78613
United StatesSite Not Available
BRCR Global Texas
Edinburg, Texas 78539
United StatesSite Not Available
Village Health Partners - Frisco Medical Village
Frisco, Texas 75033
United StatesSite Not Available
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 StatesSite Not Available
Victoria Clinical Research Group
Victoria, Texas 77901
United StatesSite Not Available
Velocity Clinical Research Austin
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
REX Clinical Trials, LLC Beaumont
Beaumont 4672989, Texas 4736286 77701-3739
United StatesSite Not Available
Velcocity Clinical Research
Cedar Park 4679867, Texas 4736286 78613
United StatesSite Not Available
BRCR Global Texas
Edinburg 4688275, Texas 4736286 78539
United StatesSite Not Available
Village Health Partners - Frisco Medical Village
Frisco 4692559, Texas 4736286 75033
United StatesSite Not Available
Cyfair Clinical Reseach Center
Houston 4699066, Texas 4736286 77065
United StatesSite Not Available
Texas Center for Drug Development
Houston 4699066, Texas 4736286 77081
United StatesSite Not Available
Ventavia Research Group
Houston 4699066, Texas 4736286 77008
United StatesSite Not Available
Victoria Clinical Research Group
Victoria 4739157, Texas 4736286 77901
United StatesSite Not Available
PI Coor Clinical Research LLC
Burke, Virginia 22015
United StatesSite Not Available
Clinical Research Partners
Richmond, Virginia 23226
United StatesSite Not Available
PI Coor Clinical Research LLC
Burke 4749950, Virginia 6254928 22015
United StatesSite Not Available
Clinical Research Partners
Richmond 4781708, Virginia 6254928 23226
United StatesSite Not Available

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