Phase
Condition
Covid-19
Treatment
Biological/Vaccine: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Open Label Crossover Vaccination period)
Clinical Study ID
Ages 6-11 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
To be included in this study, each individual must satisfy all of the following criteria:
Pediatric participants 6 months to < 12 years of age at randomization, determined tobe healthy or medically stable by the investigator (based on review of healthstatus, vital signs [to include body temperature], medical history, and targetedphysical examination [to include body weight]). Vital signs must be within thenormal range prior to the first vaccination, according to the child's age, sex,weight, and height/length.
For children from 6 months to < 12 months of age: born at full-term (≥ 37 weeksgestation) with a minimum birth weight of 2.5 kilograms (kg).
Participant and parent(s)/caregiver(s) or legally acceptable representative willingand able to give informed consent and assent, as required, prior to study enrollmentand to comply with study procedures.
Participants of childbearing potential (defined as any participant who hasexperienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateraltubal ligation, or bilateral oophorectomy]) must agree to be heterosexually inactivefrom at least 28 days prior to enrollment and through 3 months after the lastvaccination OR agree to consistently use a highly effective contraception methodfrom at least 28 days prior to enrollment and through 3 months after the lastvaccination.
Agree not to participate in another SARS-CoV-2 prevention trial for the duration ofthe study.
Exclusion
Exclusion Criteria:
If an individual meets any of the following criteria, he or she is ineligible for this study:
Any acute illness/infection (according to investigator judgment) on the day ofvaccination or febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]). A prospectivesubject should not be included in the study until the condition has resolved or thefebrile event has subsided.
Unstable acute or chronic illness. Criteria for unstable medical conditions include:
Substantive changes in chronic prescribed medication (change in class orsignificant change in dose) in the past 2 months.
Currently undergoing workup of undiagnosed illness that could lead to adiagnosis of a new condition. NOTE: Well-controlled human immunodeficiency virus [HIV] infection with undetectableHIV ribonucleic acid [RNA < 50 copies/mL] and CD4 count > 200 cells/µL for at least 1 year, documented within the last 6 months, is NOT considered an unstable chronicillness. Participant's or parent's/caregiver's verbal report will suffice asdocumentation.
Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to the first studyvaccination.
History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection orCOVID-19.
Prior administration of an investigational, authorized, or approved Coronavirusvaccine (ie, against either SARS-CoV, SARS-CoV-2, or MERS CoV) or expected receiptduring the period of study follow-up.
Previous or current diagnosis of MIS-C.
Receipt of medications intended to prevent or treat COVID-19.
Received any vaccine within 14 days prior to first study vaccination or plannedreceipt of any vaccine before Day 49 (ie, 28 days after the second vaccination),except for influenza vaccination, which may be received > 14 days prior to or > 14days after any study vaccination.
Known or suspected congenital or acquired immunodeficiency or autoimmunedisease/condition; or receipt of immunosuppressive therapy, such as anti-cancerchemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for > 14 continuous days) within 90 days prior to firststudy vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as asystemic dose ≥ 20 mg of prednisone per day or equivalent. The use of topical,inhaled, and nasal glucocorticoids is permitted. Topical tacrolimus and ocularcyclosporin are permitted. Stable autoimmune endocrine disorders (eg, thyroiditis,pancreatitis), including stable diabetes mellitus type 1, or participants with ahistory of Kawasaki disease are NOT excluded.
Received immunoglobulin or blood-derived products within 90 days prior to firststudy vaccination.
Active cancer (malignancy) on chemotherapy within 1 year prior to first studyvaccination (with the exception of malignancy cured via excision, at the discretionof the investigator).
Any known allergies to products contained in the investigational product.
Participants who are breastfeeding a child, pregnant or who plan to become pregnantwithin 3 months following the last study vaccination.
Any other condition that, in the opinion of the investigator, would pose a healthrisk to the participant if enrolled or could interfere with the evaluation of thetrial vaccine or interpretation of study results.
Study team member or first-degree relative of any study team member (inclusive ofSponsor, and study site personnel involved in the study).
Current participation in any other COVID-19 prevention clinical trial.
Participants with a history of myocarditis or pericarditis.
Study Design
Study Description
Connect with a study center
CPI Clinica Privada Independencia
Colegiales, Buenos Aires
ArgentinaSite Not Available
DIM Clinica Privada
Ramos Mejía, Buenos Aires
ArgentinaSite Not Available
Clinica Central S.A.
Villa Regina, Rio Negro
ArgentinaSite Not Available
Clinica Mayo de UMCB SRL'
San Miguel De Tucumán, Tucumán Province
ArgentinaSite Not Available
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado FMT-HVD Fundacao de Medicina Tropical do Amazonas FMTAM
Manaus, Amazonas
BrazilSite Not Available
CePCLIN
Natal, Rio Grande Do Norte
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre HCPA
Porto Alegre, Rio Grande Do Sul
BrazilSite Not Available
Hospital e Maternidade Celso Pierro- PUC Campinas
Campinas, Sao Paulo
BrazilSite Not Available
Hospital Das Clinicas
Ribeirao Preto, Sao Paulo
BrazilSite Not Available
Science Valley Research Institute
Santo André, Sao Paulo
BrazilSite Not Available
Hospital de Base de SJ RIo Preto
São José Do Rio Preto, Sao Paulo
BrazilSite Not Available
Azidus Brasil Pesquisa Cientifica e Desenvolvimento Ltda
Valinhos, Sao Paulo
BrazilSite Not Available
IBPClin Instituto Brasil de Pequisa Clinica
Rio De Janeiro,
BrazilSite Not Available
Fundacion Centro de Investigacion Clinica - CIC
Medellin, Antioquia 50021
ColombiaSite Not Available
Fundacion Centro de Investigacion Clinica - CIC
Medellín, Antioquia
ColombiaSite Not Available
Clinica de la costa
Barranquilla, Atlantico 80002
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica S.A.S-CAIMED
Puente Aranda, Bogota 111011
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica - CAIMED
Yopal, Casanare 850007
ColombiaSite Not Available
Centro de Atencion e Investigacion Medica CAIMED
Yopal, Casanare Department
ColombiaSite Not Available
CAIMED
Bogotá, Puente Aranda
ColombiaSite Not Available
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Santander 681004
ColombiaSite Not Available
Fundacin Oftalmolgica de Santander-FOSCAL
Floridablanca, Soto
ColombiaSite Not Available
Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP
Cali, Valle Del Cauca 760042
ColombiaSite Not Available
Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP
Santo Domingo, Distrito Nacional 10306
Dominican RepublicSite Not Available
MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian
Santo Domingo, Distrito Nacional 10601
Dominican RepublicSite Not Available
PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia
Santo Domingo, Distrito Nacional 10205
Dominican RepublicSite Not Available
Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)
Santo Domingo, Distrito Nacional 11901
Dominican RepublicSite Not Available
Registrum Group (Hospital Regional Marcelino Velez)
Santo Domingo, Distrito Nacional 11005
Dominican RepublicSite Not Available
Registrum Group (Hospital Regional Marcelino Velez)
Santo Domingo Oeste, Distrito Nacional 11005
Dominican RepublicSite Not Available
CECLISA
Guatemala, 01009
GuatemalaSite Not Available
Centro de Investigaciones Pediátricas (CIP)
Guatemala, 01001
GuatemalaSite Not Available
SMI (Servicios Medicos Integrales)
Guatemala, 01007
GuatemalaSite Not Available
DEMEDICA
San Pedro Sula, Cortés 21104
HondurasSite Not Available
Inverime S.A.
Tegucigalpa, Francisco Morazan 11101
HondurasSite Not Available
Investigacion Sin Limites
Tegucigalpa, Francisco Morazan 11101
HondurasSite Not Available
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan, Ciudad De Mexico 14080
MexicoSite Not Available
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco 44670
MexicoSite Not Available
Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)
Tlalpan, Mexico City 14090
MexicoSite Not Available
Panamerican Clinical Research, Mexico S.A de C.V.
Cuernavaca, Morelos 62290
MexicoSite Not Available
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P.
Mérida, Yucatan 97130
MexicoSite Not Available
Clinical Research Institute S.C.
Ciudad de México,
MexicoSite Not Available
PanAmerican
Cuernavaca,
MexicoSite Not Available
PanAmerican
Guadalajara,
MexicoSite Not Available
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P.
Merida,
MexicoSite Not Available
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirn INCMNSZ
Mexico City,
MexicoSite Not Available
Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site)
Queretaro, 76100
MexicoSite Not Available
PanAmerican
Querétaro,
MexicoSite Not Available
Clinical Research Institute S.C.
Tlalnepantla, 54055
MexicoSite Not Available
FAICIC Clinical Research
Veracruz,
MexicoSite Not Available
FAICIC S. de R.L. de C.V.
Veracruz, 91900
MexicoSite Not Available
University of the Philippines Manila - National Institutes of Health (NIH) - Institute of
San Juan, Batangas 4226
PhilippinesSite Not Available
Manila Doctors Hospital
Manila, Metro Manila 1000
PhilippinesSite Not Available
University of the Philippines - Philippine General Hospital
Manila, Metro Manila 1000
PhilippinesSite Not Available
FEU-NRMF
Quezon City, Metro Manila 1118
PhilippinesSite Not Available
National Children's Hospital
Quezon City, Metro Manila 1102
PhilippinesSite Not Available
Medical Missions Group - Lucban and Southern Luzon State University
Lucban, Quezon
PhilippinesSite Not Available
Medical Mission Group Hospital-Lucban and Southern Luzon State University
Lucena, Quezon 4328
PhilippinesSite Not Available
Chong Hua Hospital
Cebu City,
PhilippinesSite Not Available
Dr. Victor R. Potenciano Medical Center VRPMC
Mandaluyong City,
PhilippinesSite Not Available
REIMED Riger Park
Boksburg, Gauteng 1459
South AfricaSite Not Available
Setshaba Research Centre
Ga-Tshwene, Gauteng 0152
South AfricaSite Not Available
Soweto Clinical Trials Centre
Johannesburg, Gauteng 1818
South AfricaSite Not Available
WiWits RHI - Shandukani Research Centre
Johannesburg, Gauteng 2001
South AfricaSite Not Available
Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng 2093
South AfricaSite Not Available
Setshaba Research Centre
Pretoria, Gauteng 0152
South AfricaSite Not Available
Wits Vida- Chris Hani Baragwanath Hospital
Soweto, Gauteng 1862
South AfricaSite Not Available
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo 0380
South AfricaSite Not Available
Tiervlei Trial Centre
Bellville, Western Cape 7530
South AfricaSite Not Available
Be Part Yoluntu Centre - Paarl
Paarl, Western Cape 7655
South AfricaSite Not Available
Stellenbosch University Worcester
Worcester, Western Cape 6850
South AfricaSite Not Available
Stellenbosch University Worcester
Cape Town,
South AfricaSite Not Available
Reimed Reiger Park
Vosloorus,
South AfricaSite Not Available
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña 15706
SpainSite Not Available
Hospital Universitario Severo Ochoa
Leganés, Madrid 28911
SpainSite Not Available
Hospital Universitario de Torrejon
Torrejon de Ardoz, Madrid 28850
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol
Badalona,
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Lakeside Healthcare Research
Corby, Northamptonshire NN17 2UR
United KingdomSite Not Available
St Georges Hospital
London, SW17 0QT
United KingdomSite Not Available
NIHR WTCRF Uni. Hospital Southampton NHS FT
Southampton,
United KingdomSite Not Available
Preferred Research Partners, Inc.
Little Rock, Arkansas 72211
United StatesSite Not Available
Advanced Research Center
Anaheim, California 92805
United StatesSite Not Available
Coast Clinical Research, LLC
Bellflower, California 90706
United StatesSite Not Available
Apex Research Group
Fair Oaks, California 95628
United StatesSite Not Available
Ark Clinical Research
Long Beach, California 90815
United StatesSite Not Available
Orange County Research Institute
Ontario, California 91762
United StatesSite Not Available
California Research Foundation
San Diego, California 92123
United StatesSite Not Available
Clinical Research of California
Walnut Creek, California 94598
United StatesSite Not Available
Imagine Research of Palm Beach County
Boynton Beach, Florida 33435
United StatesSite Not Available
Palm Harbor Dermatology PA
Brandon, Florida 33511
United StatesSite Not Available
Westside Center for Clinical Research
Jacksonville, Florida 32205
United StatesSite Not Available
Cordova Research Institute, LLC
Miami, Florida 33155
United StatesSite Not Available
ARS-Nona Pediatric Center
Orlando, Florida 32829
United StatesSite Not Available
MOORE Clinical Research
Tampa, Florida 33511
United StatesActive - Recruiting
Palm Harbor Dermatology PA
Tampa, Florida 33511
United StatesSite Not Available
Morehouse School of Medicine
Atlanta, Georgia 30310
United StatesSite Not Available
Tekton Research - Atlanta
Chamblee, Georgia 30341
United StatesSite Not Available
Leavitt Clinical Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Michael W. Simon, M.D., PSC
Lexington, Kentucky 40517
United StatesSite Not Available
Bluegrass Clinical Research, Inc./All Children Pediatrics
Louisville, Kentucky 40243
United StatesSite Not Available
MedPharmics - Covington, LA
Covington, Louisiana 70433
United StatesActive - Recruiting
Velocity Clinical Research - Covington
Covington, Louisiana 70433
United StatesSite Not Available
Velocity Clinical Research - Covington, LA
Covington, Louisiana 70433
United StatesSite Not Available
MedPharmics
Lafayette, Louisiana 70508
United StatesActive - Recruiting
Velocity Clinical Research - Lafayette LA
Lafayette, Louisiana 70508
United StatesSite Not Available
MedPharmics - Covington LA
Slidell, Louisiana 70458
United StatesSite Not Available
Craig A. Spiegel, M.D.
Bridgeton, Missouri 63044
United StatesSite Not Available
Boeson Research
Missoula, Montana 59804
United StatesSite Not Available
Be Well Clinical Studies, LLC
Lincoln, Nebraska 68516
United StatesSite Not Available
Meridian Clinical Research
Lincoln, Nebraska 68510
United StatesSite Not Available
Corning Center for Clinical Research
Horseheads, New York 14845
United StatesSite Not Available
Velocity Clinical Research
Beachwood, Ohio 44122
United StatesSite Not Available
Velocity - Cleveland
Cleveland, Ohio 44101
United StatesSite Not Available
Dayton Clinical Research
Dayton, Ohio 45409
United StatesSite Not Available
Senders Pediatrics
South Euclid, Ohio 44121
United StatesSite Not Available
Lynn Institute of Tulsa
Tulsa, Oklahoma 74135
United StatesSite Not Available
Velocity Clinical Research Grants Pass
Grants Pass, Oregon 97527
United StatesSite Not Available
Tribe Clinical Research
Greenville, South Carolina 29607
United StatesSite Not Available
WR - ClinSearch, LLC
Chattanooga, Tennessee 37421
United StatesSite Not Available
Clinical Research Associates, Inc.
Nashville, Tennessee 37203
United StatesSite Not Available
Tekton Research
Beaumont, Texas 77706
United StatesActive - Recruiting
Tekton Research Beaumont
Beaumont, Texas 77706
United StatesSite Not Available
PanAmerican Clinical Research
Brownsville, Texas 78520
United StatesSite Not Available
Coastal Bend Clinical Research
Corpus Christi, Texas 78413
United StatesActive - Recruiting
South Texas Clinical Research
Corpus Christi, Texas 78404
United StatesSite Not Available
Bay Colony Pediatrics
Dickinson, Texas 77539
United StatesSite Not Available
Mercury Clinical Research
Houston, Texas 77087
United StatesSite Not Available
Trio Clinical Trials
Houston, Texas 77008
United StatesSite Not Available
Research Your Health
Plano, Texas 75093
United StatesSite Not Available
Mercury Clinical Research - Pediatric Center
Richmond, Texas 77469
United StatesSite Not Available
Tekton Research
San Antonio, Texas 78244
United StatesSite Not Available
Alliance for Multispecialty Research
Layton, Utah 84041
United StatesSite Not Available
Alliance for Multispecialty Research c/o Wee Care Pediatrics - Roy
Roy, Utah 84067
United StatesSite Not Available
Velocity Clinical Research - West Jordan
West Jordan, Utah 84088
United StatesSite Not Available
Clinical Research Partners, LLC
Richmond, Virginia 23226
United StatesSite Not Available
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