Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

3,600

Participants

Timeline

Start Date

July 22, 2022

Primary Completion Date

January 16, 2024

Study Completion Date

October 25, 2025

Conditions
COVID-19
Interventions
BIOLOGICAL

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)

Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) (or fractional dose if necessary) on Days 0 and 21 in the Initial Vaccination Period.

OTHER

Placebo

Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in the Initial Vaccination Period or on Days 201 or Day 229 in the Booster Vaccination Period

Trial Locations (94)

1000

Manila Doctors Hospital, Manila

University of the Philippines - Philippine General Hospital, Manila

1102

National Children's Hospital, Quezon City

1118

FEU-NRMF, Quezon City

1459

REIMED Riger Park, Boksburg

1818

Soweto Clinical Trials Centre, Johannesburg

1862

Wits Vida- Chris Hani Baragwanath Hospital, Soweto

2001

WiWits RHI - Shandukani Research Centre, Johannesburg

2093

Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital, Johannesburg

4226

University of the Philippines Manila - National Institutes of Health (NIH) - Institute of, San Juan City

4328

Medical Mission Group Hospital-Lucban and Southern Luzon State University, Lucena City

6850

Stellenbosch University Worcester, Worcester

7530

Tiervlei Trial Centre, Bellville

7655

Be Part Yoluntu Centre - Paarl, Paarl

10205

PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia, Santo Domingo

10306

Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP, Santo Domingo

10601

MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian, Santo Domingo

11005

Registrum Group (Hospital Regional Marcelino Velez), Santo Domingo

11101

Inverime S.A., Tegucigalpa

Investigacion Sin Limites, Tegucigalpa

11901

Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina), Santo Domingo

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Tlalpan

14090

Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa), Tlalpan

14845

Corning Center for Clinical Research, Horseheads

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

21104

DEMEDICA, San Pedro Sula

23226

Clinical Research Partners, LLC, Richmond

28041

Hospital Universitario 12 de Octubre, Madrid

28850

Hospital Universitario de Torrejon, Torrejón de Ardoz

28911

Hospital Universitario Severo Ochoa, Leganés

29607

Tribe Clinical Research, Greenville

30310

Morehouse School of Medicine, Atlanta

30341

Tekton Research - Atlanta, Chamblee

32205

Westside Center for Clinical Research, Jacksonville

32829

ARS-Nona Pediatric Center, Orlando

33155

Cordova Research Institute, LLC, Miami

33435

Imagine Research of Palm Beach County, Boynton Beach

33511

Palm Harbor Dermatology PA, Brandon

37203

Clinical Research Associates, Inc., Nashville

37421

WR - ClinSearch, LLC, Chattanooga

40243

Bluegrass Clinical Research, Inc./All Children Pediatrics, Louisville

40517

Michael W. Simon, M.D., PSC, Lexington

44121

Senders Pediatrics, South Euclid

44122

Velocity Clinical Research, Beachwood

44670

Panamerican Clinical Research S.A de C.V., Guadalajara

45409

Dayton Clinical Research, Dayton

50021

Fundacion Centro de Investigacion Clinica - CIC, Medellín

54055

Clinical Research Institute S.C., Tlalnepantla

59804

Boeson Research, Missoula

62290

Panamerican Clinical Research, Mexico S.A de C.V., Cuernavaca

63044

Craig A. Spiegel, M.D., Bridgeton

68510

Meridian Clinical Research, Lincoln

68516

Be Well Clinical Studies, LLC, Lincoln

70433

Velocity Clinical Research - Covington, LA, Covington

Velocity Clinical Research - Covington, Covington

70508

Velocity Clinical Research - Lafayette LA, Lafayette

72211

Preferred Research Partners, Inc., Little Rock

74135

Lynn Institute of Tulsa, Tulsa

75093

Research Your Health, Plano

76100

Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site), Querétaro

77008

Trio Clinical Trials, Houston

77087

Mercury Clinical Research, Houston

77469

Mercury Clinical Research - Pediatric Center, Richmond

77539

Bay Colony Pediatrics, Dickinson

77706

Tekton Research Beaumont, Beaumont

78244

Tekton Research, San Antonio

78404

South Texas Clinical Research, Corpus Christi

78520

PanAmerican Clinical Research, Brownsville

80002

Clinica de la costa, Barranquilla

83404

Leavitt Clinical Research, Idaho Falls

84041

Alliance for Multispecialty Research, Layton

84067

Alliance for Multispecialty Research c/o Wee Care Pediatrics - Roy, Roy

84088

Velocity Clinical Research - West Jordan, West Jordan

90706

Coast Clinical Research, LLC, Bellflower

90815

Ark Clinical Research, Long Beach

91762

Orange County Research Institute, Ontario

91900

FAICIC S. de R.L. de C.V., Veracruz

92123

California Research Foundation, San Diego

92805

Advanced Research Center, Anaheim

94598

Clinical Research of California, Walnut Creek

95628

Apex Research Group, Fair Oaks

97130

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P., Mérida

97527

Velocity Clinical Research Grants Pass, Grants Pass

111011

Centro de Atencion e Investigacion Medica S.A.S-CAIMED, Puente Aranda

681004

Fundacion Oftalmologica de Santander - FOSCAL, Floridablanca

760042

Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP, Santiago de Cali

850007

Centro de Atencion e Investigacion Medica - CAIMED, Yopal

01001

Centro de Investigaciones Pediátricas (CIP), Guatemala City

01007

SMI (Servicios Medicos Integrales), Guatemala City

01009

CECLISA, Guatemala City

0152

Setshaba Research Centre, Ga-Tshwene

0380

Limpopo Clinical Research Initiative, Thabazimbi

NN17 2UR

Lakeside Healthcare Research, Corby

SW17 0QT

St Georges Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY

NCT05468736 - Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years | Biotech Hunter | Biotech Hunter