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

Last updated: December 18, 2024
Sponsor: Novavax
Overall Status: Active - Not Recruiting

Phase

2/3

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

NCT05468736
2019nCoV-503
  • Ages 6-11
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to < 12 years, 2 to < 6 years, and 6 to < 24 months of age). Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to < 12 years of age).

Eligibility Criteria

Inclusion

Inclusion Criteria:

To be included in this study, each individual must satisfy all of the following criteria:

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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:

  1. 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.

  2. Unstable acute or chronic illness. Criteria for unstable medical conditions include:

  3. Substantive changes in chronic prescribed medication (change in class orsignificant change in dose) in the past 2 months.

  4. 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.

  5. Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to the first studyvaccination.

  6. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection orCOVID-19.

  7. 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.

  8. Previous or current diagnosis of MIS-C.

  9. Receipt of medications intended to prevent or treat COVID-19.

  10. 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.

  11. 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.

  12. Received immunoglobulin or blood-derived products within 90 days prior to firststudy vaccination.

  13. 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).

  14. Any known allergies to products contained in the investigational product.

  15. Participants who are breastfeeding a child, pregnant or who plan to become pregnantwithin 3 months following the last study vaccination.

  16. 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.

  17. Study team member or first-degree relative of any study team member (inclusive ofSponsor, and study site personnel involved in the study).

  18. Current participation in any other COVID-19 prevention clinical trial.

  19. Participants with a history of myocarditis or pericarditis.

Study Design

Total Participants: 3600
Treatment Group(s): 5
Primary Treatment: Biological/Vaccine: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Phase: 2/3
Study Start date:
July 22, 2022
Estimated Completion Date:
October 25, 2025

Study Description

This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-based vaccine given as a booster dose or at crossover in pediatric participants (3 age cohorts; 6 to < 12 years, 2 to < 6 years, and 6 to < 24 months of age).

Each age cohort will be conducted in 2 parts starting with the oldest age cohort (6 to < 12 years of age).

Part 1 will enroll approximately 120 healthy or medically stable sentinel participants per age cohort (10% of the intended enrollment population per age cohort, for a total of 360 sentinel participants overall) who will be randomized in a 1:1 ratio to receive 2 doses of NVX-CoV2373 or placebo with doses given 21 days apart.

Part 2 will enroll a larger number of healthy or medically stable participants (N= approximately 1,080 per age cohort), for a total of approximately 3,240 pediatric participants enrolled in Part 2, and a total of approximately 3,600 participants enrolled in the entire trial). Initial randomization in Part 2 will be in a 2:1 ratio, and the safety and effectiveness of 2 doses of NVX-CoV2373 given 21 days apart will be assessed.

Connect with a study center

  • CPI Clinica Privada Independencia

    Colegiales, Buenos Aires
    Argentina

    Site Not Available

  • DIM Clinica Privada

    Ramos Mejía, Buenos Aires
    Argentina

    Site Not Available

  • Clinica Central S.A.

    Villa Regina, Rio Negro
    Argentina

    Site Not Available

  • Clinica Mayo de UMCB SRL'

    San Miguel De Tucumán, Tucumán Province
    Argentina

    Site Not Available

  • Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado FMT-HVD Fundacao de Medicina Tropical do Amazonas FMTAM

    Manaus, Amazonas
    Brazil

    Site Not Available

  • CePCLIN

    Natal, Rio Grande Do Norte
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre HCPA

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Hospital e Maternidade Celso Pierro- PUC Campinas

    Campinas, Sao Paulo
    Brazil

    Site Not Available

  • Hospital Das Clinicas

    Ribeirao Preto, Sao Paulo
    Brazil

    Site Not Available

  • Science Valley Research Institute

    Santo André, Sao Paulo
    Brazil

    Site Not Available

  • Hospital de Base de SJ RIo Preto

    São José Do Rio Preto, Sao Paulo
    Brazil

    Site Not Available

  • Azidus Brasil Pesquisa Cientifica e Desenvolvimento Ltda

    Valinhos, Sao Paulo
    Brazil

    Site Not Available

  • IBPClin Instituto Brasil de Pequisa Clinica

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Fundacion Centro de Investigacion Clinica - CIC

    Medellin, Antioquia 50021
    Colombia

    Site Not Available

  • Fundacion Centro de Investigacion Clinica - CIC

    Medellín, Antioquia
    Colombia

    Site Not Available

  • Clinica de la costa

    Barranquilla, Atlantico 80002
    Colombia

    Site Not Available

  • Centro de Atencion e Investigacion Medica S.A.S-CAIMED

    Puente Aranda, Bogota 111011
    Colombia

    Site Not Available

  • Centro de Atencion e Investigacion Medica - CAIMED

    Yopal, Casanare 850007
    Colombia

    Site Not Available

  • Centro de Atencion e Investigacion Medica CAIMED

    Yopal, Casanare Department
    Colombia

    Site Not Available

  • CAIMED

    Bogotá, Puente Aranda
    Colombia

    Site Not Available

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, Santander 681004
    Colombia

    Site Not Available

  • Fundacin Oftalmolgica de Santander-FOSCAL

    Floridablanca, Soto
    Colombia

    Site Not Available

  • Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP

    Cali, Valle Del Cauca 760042
    Colombia

    Site Not Available

  • Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP

    Santo Domingo, Distrito Nacional 10306
    Dominican Republic

    Site Not Available

  • MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian

    Santo Domingo, Distrito Nacional 10601
    Dominican Republic

    Site Not Available

  • PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia

    Santo Domingo, Distrito Nacional 10205
    Dominican Republic

    Site Not Available

  • Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)

    Santo Domingo, Distrito Nacional 11901
    Dominican Republic

    Site Not Available

  • Registrum Group (Hospital Regional Marcelino Velez)

    Santo Domingo, Distrito Nacional 11005
    Dominican Republic

    Site Not Available

  • Registrum Group (Hospital Regional Marcelino Velez)

    Santo Domingo Oeste, Distrito Nacional 11005
    Dominican Republic

    Site Not Available

  • CECLISA

    Guatemala, 01009
    Guatemala

    Site Not Available

  • Centro de Investigaciones Pediátricas (CIP)

    Guatemala, 01001
    Guatemala

    Site Not Available

  • SMI (Servicios Medicos Integrales)

    Guatemala, 01007
    Guatemala

    Site Not Available

  • DEMEDICA

    San Pedro Sula, Cortés 21104
    Honduras

    Site Not Available

  • Inverime S.A.

    Tegucigalpa, Francisco Morazan 11101
    Honduras

    Site Not Available

  • Investigacion Sin Limites

    Tegucigalpa, Francisco Morazan 11101
    Honduras

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Tlalpan, Ciudad De Mexico 14080
    Mexico

    Site Not Available

  • Panamerican Clinical Research S.A de C.V.

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)

    Tlalpan, Mexico City 14090
    Mexico

    Site Not Available

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

    Cuernavaca, Morelos 62290
    Mexico

    Site Not Available

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

    Mérida, Yucatan 97130
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Ciudad de México,
    Mexico

    Site Not Available

  • PanAmerican

    Cuernavaca,
    Mexico

    Site Not Available

  • PanAmerican

    Guadalajara,
    Mexico

    Site Not Available

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

    Merida,
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirn INCMNSZ

    Mexico City,
    Mexico

    Site Not Available

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

    Queretaro, 76100
    Mexico

    Site Not Available

  • PanAmerican

    Querétaro,
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055
    Mexico

    Site Not Available

  • FAICIC Clinical Research

    Veracruz,
    Mexico

    Site Not Available

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900
    Mexico

    Site Not Available

  • University of the Philippines Manila - National Institutes of Health (NIH) - Institute of

    San Juan, Batangas 4226
    Philippines

    Site Not Available

  • Manila Doctors Hospital

    Manila, Metro Manila 1000
    Philippines

    Site Not Available

  • University of the Philippines - Philippine General Hospital

    Manila, Metro Manila 1000
    Philippines

    Site Not Available

  • FEU-NRMF

    Quezon City, Metro Manila 1118
    Philippines

    Site Not Available

  • National Children's Hospital

    Quezon City, Metro Manila 1102
    Philippines

    Site Not Available

  • Medical Missions Group - Lucban and Southern Luzon State University

    Lucban, Quezon
    Philippines

    Site Not Available

  • Medical Mission Group Hospital-Lucban and Southern Luzon State University

    Lucena, Quezon 4328
    Philippines

    Site Not Available

  • Chong Hua Hospital

    Cebu City,
    Philippines

    Site Not Available

  • Dr. Victor R. Potenciano Medical Center VRPMC

    Mandaluyong City,
    Philippines

    Site Not Available

  • REIMED Riger Park

    Boksburg, Gauteng 1459
    South Africa

    Site Not Available

  • Setshaba Research Centre

    Ga-Tshwene, Gauteng 0152
    South Africa

    Site Not Available

  • Soweto Clinical Trials Centre

    Johannesburg, Gauteng 1818
    South Africa

    Site Not Available

  • WiWits RHI - Shandukani Research Centre

    Johannesburg, Gauteng 2001
    South Africa

    Site Not Available

  • Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital

    Johannesburg, Gauteng 2093
    South Africa

    Site Not Available

  • Setshaba Research Centre

    Pretoria, Gauteng 0152
    South Africa

    Site Not Available

  • Wits Vida- Chris Hani Baragwanath Hospital

    Soweto, Gauteng 1862
    South Africa

    Site Not Available

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo 0380
    South Africa

    Site Not Available

  • Tiervlei Trial Centre

    Bellville, Western Cape 7530
    South Africa

    Site Not Available

  • Be Part Yoluntu Centre - Paarl

    Paarl, Western Cape 7655
    South Africa

    Site Not Available

  • Stellenbosch University Worcester

    Worcester, Western Cape 6850
    South Africa

    Site Not Available

  • Stellenbosch University Worcester

    Cape Town,
    South Africa

    Site Not Available

  • Reimed Reiger Park

    Vosloorus,
    South Africa

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid 28911
    Spain

    Site Not Available

  • Hospital Universitario de Torrejon

    Torrejon de Ardoz, Madrid 28850
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Lakeside Healthcare Research

    Corby, Northamptonshire NN17 2UR
    United Kingdom

    Site Not Available

  • St Georges Hospital

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • NIHR WTCRF Uni. Hospital Southampton NHS FT

    Southampton,
    United Kingdom

    Site Not Available

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Advanced Research Center

    Anaheim, California 92805
    United States

    Site Not Available

  • Coast Clinical Research, LLC

    Bellflower, California 90706
    United States

    Site Not Available

  • Apex Research Group

    Fair Oaks, California 95628
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Site Not Available

  • Orange County Research Institute

    Ontario, California 91762
    United States

    Site Not Available

  • California Research Foundation

    San Diego, California 92123
    United States

    Site Not Available

  • Clinical Research of California

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Imagine Research of Palm Beach County

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Palm Harbor Dermatology PA

    Brandon, Florida 33511
    United States

    Site Not Available

  • Westside Center for Clinical Research

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Cordova Research Institute, LLC

    Miami, Florida 33155
    United States

    Site Not Available

  • ARS-Nona Pediatric Center

    Orlando, Florida 32829
    United States

    Site Not Available

  • MOORE Clinical Research

    Tampa, Florida 33511
    United States

    Active - Recruiting

  • Palm Harbor Dermatology PA

    Tampa, Florida 33511
    United States

    Site Not Available

  • Morehouse School of Medicine

    Atlanta, Georgia 30310
    United States

    Site Not Available

  • Tekton Research - Atlanta

    Chamblee, Georgia 30341
    United States

    Site Not Available

  • Leavitt Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Michael W. Simon, M.D., PSC

    Lexington, Kentucky 40517
    United States

    Site Not Available

  • Bluegrass Clinical Research, Inc./All Children Pediatrics

    Louisville, Kentucky 40243
    United States

    Site Not Available

  • MedPharmics - Covington, LA

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Velocity Clinical Research - Covington

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Velocity Clinical Research - Covington, LA

    Covington, Louisiana 70433
    United States

    Site Not Available

  • MedPharmics

    Lafayette, Louisiana 70508
    United States

    Active - Recruiting

  • Velocity Clinical Research - Lafayette LA

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • MedPharmics - Covington LA

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • Craig A. Spiegel, M.D.

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • Boeson Research

    Missoula, Montana 59804
    United States

    Site Not Available

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Meridian Clinical Research

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Corning Center for Clinical Research

    Horseheads, New York 14845
    United States

    Site Not Available

  • Velocity Clinical Research

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Velocity - Cleveland

    Cleveland, Ohio 44101
    United States

    Site Not Available

  • Dayton Clinical Research

    Dayton, Ohio 45409
    United States

    Site Not Available

  • Senders Pediatrics

    South Euclid, Ohio 44121
    United States

    Site Not Available

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Velocity Clinical Research Grants Pass

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • Tribe Clinical Research

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • WR - ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Clinical Research Associates, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tekton Research

    Beaumont, Texas 77706
    United States

    Active - Recruiting

  • Tekton Research Beaumont

    Beaumont, Texas 77706
    United States

    Site Not Available

  • PanAmerican Clinical Research

    Brownsville, Texas 78520
    United States

    Site Not Available

  • Coastal Bend Clinical Research

    Corpus Christi, Texas 78413
    United States

    Active - Recruiting

  • South Texas Clinical Research

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Bay Colony Pediatrics

    Dickinson, Texas 77539
    United States

    Site Not Available

  • Mercury Clinical Research

    Houston, Texas 77087
    United States

    Site Not Available

  • Trio Clinical Trials

    Houston, Texas 77008
    United States

    Site Not Available

  • Research Your Health

    Plano, Texas 75093
    United States

    Site Not Available

  • Mercury Clinical Research - Pediatric Center

    Richmond, Texas 77469
    United States

    Site Not Available

  • Tekton Research

    San Antonio, Texas 78244
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Layton, Utah 84041
    United States

    Site Not Available

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

    Roy, Utah 84067
    United States

    Site Not Available

  • Velocity Clinical Research - West Jordan

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Clinical Research Partners, LLC

    Richmond, Virginia 23226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.