This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalationtrial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS withMatrix-M™ adjuvant (NVX-CoV2373) given 21 days apart and NVX CoV2373 or a variant-basedvaccine 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 beconducted in 2 parts starting with the oldest age cohort (6 to < 12 years of age).
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.
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 Name: NVX-CoV2373
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
Other Name: Sodium chloride 0.9% (BP, sterile)
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 to
be healthy or medically stable by the investigator (based on review of health
status, vital signs [to include body temperature], medical history, and targeted
physical examination [to include body weight]). Vital signs must be within the
normal 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 weeks
gestation) with a minimum birth weight of 2.5 kilograms (kg).
3. Participant and parent(s)/caregiver(s) or legally acceptable representative willing
and able to give informed consent and assent, as required, prior to study enrollment
and to comply with study procedures.
4. Participants of childbearing potential (defined as any participant who has
experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy]) must agree to be heterosexually inactive
from at least 28 days prior to enrollment and through 3 months after the last
vaccination OR agree to consistently use a highly effective contraception method
from at least 28 days prior to enrollment and through 3 months after the last
vaccination.
5. Agree not to participate in another SARS-CoV-2 prevention trial for the duration of
the study.
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 of
vaccination or febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]). A prospective
subject should not be included in the study until the condition has resolved or the
febrile event has subsided.
2. Unstable acute or chronic illness. Criteria for unstable medical conditions include:
1. Substantive changes in chronic prescribed medication (change in class or
significant change in dose) in the past 2 months.
2. Currently undergoing workup of undiagnosed illness that could lead to a
diagnosis of a new condition.
NOTE: Well-controlled human immunodeficiency virus [HIV] infection with undetectable
HIV 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 chronic
illness. Participant's or parent's/caregiver's verbal report will suffice as
documentation.
3. Participation in research involving an investigational product
(drug/biologic/device) administered within 45 days prior to the first study
vaccination.
4. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or
COVID-19.
5. Prior administration of an investigational, authorized, or approved Coronavirus
vaccine (ie, against either SARS-CoV, SARS-CoV-2, or MERS CoV) or expected receipt
during the period of study follow-up.
6. Previous or current diagnosis of MIS-C.
7. Receipt of medications intended to prevent or treat COVID-19.
8. Received any vaccine within 14 days prior to first study vaccination or planned
receipt 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 > 14
days after any study vaccination.
9. Known or suspected congenital or acquired immunodeficiency or autoimmune
disease/condition; or receipt of immunosuppressive therapy, such as anti-cancer
chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
(prednisone or equivalent for > 14 continuous days) within 90 days prior to first
study vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a
systemic dose ≥ 20 mg of prednisone per day or equivalent. The use of topical,
inhaled, and nasal glucocorticoids is permitted. Topical tacrolimus and ocular
cyclosporin are permitted. Stable autoimmune endocrine disorders (eg, thyroiditis,
pancreatitis), including stable diabetes mellitus type 1, or participants with a
history of Kawasaki disease are NOT excluded.
10. Received immunoglobulin or blood-derived products within 90 days prior to first
study vaccination.
11. Active cancer (malignancy) on chemotherapy within 1 year prior to first study
vaccination (with the exception of malignancy cured via excision, at the discretion
of the investigator).
12. Any known allergies to products contained in the investigational product.
13. Participants who are breastfeeding a child, pregnant or who plan to become pregnant
within 3 months following the last study vaccination.
14. Any other condition that, in the opinion of the investigator, would pose a health
risk to the participant if enrolled or could interfere with the evaluation of the
trial vaccine or interpretation of study results.
15. Study team member or first-degree relative of any study team member (inclusive of
Sponsor, and study site personnel involved in the study).
16. Current participation in any other COVID-19 prevention clinical trial.
17. Participants with a history of myocarditis or pericarditis.
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Advanced Research Center
Anaheim, California, United States
Coast Clinical Research, LLC
Bellflower, California, United States
Apex Research Group
Fair Oaks, California, United States
Ark Clinical Research
Long Beach, California, United States
Orange County Research Institute
Ontario, California, United States
California Research Foundation
San Diego, California, United States
Clinical Research of California
Walnut Creek, California, United States
Imagine Research of Palm Beach County
Boynton Beach, Florida, United States
Palm Harbor Dermatology PA
Brandon, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Cordova Research Institute, LLC
Miami, Florida, United States
ARS-Nona Pediatric Center
Orlando, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Tekton Research - Atlanta
Chamblee, Georgia, United States
Leavitt Clinical Research
Idaho Falls, Idaho, United States
Michael W. Simon, M.D., PSC
Lexington, Kentucky, United States
Bluegrass Clinical Research, Inc./All Children Pediatrics
Louisville, Kentucky, United States
Velocity Clinical Research - Covington, LA
Covington, Louisiana, United States
Velocity Clinical Research - Covington
Covington, Louisiana, United States
Velocity Clinical Research - Lafayette LA
Lafayette, Louisiana, United States
Craig A. Spiegel, M.D.
Bridgeton, Missouri, United States
Boeson Research
Missoula, Montana, United States
Meridian Clinical Research
Lincoln, Nebraska, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska, United States
Corning Center for Clinical Research
Horseheads, New York, United States
Velocity Clinical Research
Beachwood, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Lynn Institute of Tulsa
Tulsa, Oklahoma, United States
Velocity Clinical Research Grants Pass
Grants Pass, Oregon, United States
Tribe Clinical Research
Greenville, South Carolina, United States
WR - ClinSearch, LLC
Chattanooga, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Tekton Research Beaumont
Beaumont, Texas, United States
PanAmerican Clinical Research
Brownsville, Texas, United States
South Texas Clinical Research
Corpus Christi, Texas, United States
Bay Colony Pediatrics
Dickinson, Texas, United States
Trio Clinical Trials
Houston, Texas, United States
Mercury Clinical Research
Houston, Texas, United States
Research Your Health
Plano, Texas, United States
Mercury Clinical Research - Pediatric Center
Richmond, Texas, United States
Tekton Research
San Antonio, Texas, United States
Alliance for Multispecialty Research
Layton, Utah, United States
Alliance for Multispecialty Research c/o Wee Care Pediatrics - Roy
Roy, Utah, United States
Velocity Clinical Research - West Jordan
West Jordan, Utah, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Fundacion Centro de Investigacion Clinica - CIC
Medellin, Antioquia, Colombia
Clinica de la costa
Barranquilla, Atlantico, Colombia
Centro de Atencion e Investigacion Medica S.A.S-CAIMED
Puente Aranda, Bogota, Colombia
Centro de Atencion e Investigacion Medica - CAIMED
Yopal, Casanare, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Santander, Colombia
Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP
Cali, Valle Del Cauca, Colombia
PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia
Santo Domingo, Distrito Nacional, Dominican Republic
Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP
Santo Domingo, Distrito Nacional, Dominican Republic
MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian
Santo Domingo, Distrito Nacional, Dominican Republic
Registrum Group (Hospital Regional Marcelino Velez)
Santo Domingo, Distrito Nacional, Dominican Republic
Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)
Santo Domingo, Distrito Nacional, Dominican Republic
Centro de Investigaciones Pediátricas (CIP)
Guatemala, Guatemala
SMI (Servicios Medicos Integrales)
Guatemala, Guatemala
CECLISA
Guatemala, Guatemala
DEMEDICA
San Pedro Sula, Cortés, Honduras
Inverime S.A.
Tegucigalpa, Francisco Morazan, Honduras
Investigacion Sin Limites
Tegucigalpa, Francisco Morazan, Honduras
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan, Ciudad De Mexico, Mexico
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco, Mexico
Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)
Tlalpan, Mexico City, Mexico
Panamerican Clinical Research, Mexico S.A de C.V.
Cuernavaca, Morelos, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P.
Mérida, Yucatan, Mexico
Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site)
Queretaro, Mexico
Clinical Research Institute S.C.
Tlalnepantla, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Mexico
University of the Philippines Manila - National Institutes of Health (NIH) - Institute of
San Juan, Batangas, Philippines
Manila Doctors Hospital
Manila, Metro Manila, Philippines
University of the Philippines - Philippine General Hospital
Manila, Metro Manila, Philippines
National Children's Hospital
Quezon City, Metro Manila, Philippines
FEU-NRMF
Quezon City, Metro Manila, Philippines
Medical Mission Group Hospital-Lucban and Southern Luzon State University
Lucena, Quezon, Philippines
REIMED Riger Park
Boksburg, Gauteng, South Africa
Setshaba Research Centre
Ga-Tshwene, Gauteng, South Africa
Soweto Clinical Trials Centre
Johannesburg, Gauteng, South Africa
WiWits RHI - Shandukani Research Centre
Johannesburg, Gauteng, South Africa
Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital
Johannesburg, Gauteng, South Africa
Wits Vida- Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo, South Africa
Tiervlei Trial Centre
Bellville, Western Cape, South Africa
Be Part Yoluntu Centre - Paarl
Paarl, Western Cape, South Africa
Stellenbosch University Worcester
Worcester, Western Cape, South Africa
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario de Torrejon
Torrejon de Ardoz, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Lakeside Healthcare Research
Corby, Northamptonshire, United Kingdom
St Georges Hospital
London, United Kingdom
Clinical Development, Study Director
Novavax, Inc.