Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
NCT ID: NCT05468736
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
3600 participants
INTERVENTIONAL
2022-07-22
2025-10-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Cohort-1(6 to < 12 y)-Part-1(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
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.
Cohort-1(6 to < 12 y)-Part-1(Placebo)
Placebo (normal saline)
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
Cohort-1(6 to < 12 y)-Part-2(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
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.
Cohort-1(6 to < 12 y)-Part-2(Placebo)
Placebo (normal saline)
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
Cohort-2(2 to < 6 y)-Part-1(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
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.
Cohort-2(2 to < 6 y)-Part-1(Placebo)
Placebo (normal saline)
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
Cohort-2(2 to < 6 y)-Part-2(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
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.
Cohort-2(2 to < 6 y)-Part-2(Placebo)
Placebo (normal saline)
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
Cohort-3(6 to < 24 m)-Part-1(Active Vaccine)
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
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.
Cohort-3(6 to < 24 m)-Part-1(Placebo)
Placebo (normal saline)
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
Cohort-3(6 to < 24 m)-Part-2
NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)
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.
Cohort-3(6 to < 24 m)-Part-2(Placebo)
Placebo (normal saline)
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
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
6 Months
11 Years
ALL
Yes
Sponsors
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Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Novavax, Inc.
Locations
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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
Medellín, Antioquia, Colombia
Clinica de la costa
Barranquilla, Atlántico, Colombia
Centro de Atencion e Investigacion Medica S.A.S-CAIMED
Puente Aranda, Bogota D.C., Colombia
Centro de Atencion e Investigacion Medica - CAIMED
Yopal, Casanare Department, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Santander Department, Colombia
Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP
Cali, Valle del Cauca Department, Colombia
PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia
Santo Domingo, Nacional, Dominican Republic
Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP
Santo Domingo, Nacional, Dominican Republic
MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian
Santo Domingo, Nacional, Dominican Republic
Registrum Group (Hospital Regional Marcelino Velez)
Santo Domingo, Nacional, Dominican Republic
Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)
Santo Domingo, Nacional, Dominican Republic
Centro de Investigaciones Pediátricas (CIP)
Guatemala City, , Guatemala
SMI (Servicios Medicos Integrales)
Guatemala City, , Guatemala
CECLISA
Guatemala City, , Guatemala
DEMEDICA
San Pedro Sula, Cortés Department, Honduras
Inverime S.A.
Tegucigalpa, Francisco Morazán Department, Honduras
Investigacion Sin Limites
Tegucigalpa, Francisco Morazán Department, Honduras
Panamerican Clinical Research S.A de C.V.
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan, Mexico City, 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, Yucatán, Mexico
Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site)
Querétaro, , 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 City, Batangas, Philippines
Manila Doctors Hospital
Manila, National Capital Region, Philippines
University of the Philippines - Philippine General Hospital
Manila, National Capital Region, Philippines
National Children's Hospital
Quezon City, National Capital Region, Philippines
FEU-NRMF
Quezon City, National Capital Region, Philippines
Medical Mission Group Hospital-Lucban and Southern Luzon State University
Lucena City, 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
Torrejón de Ardoz, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Lakeside Healthcare Research
Corby, Northamptonshire, United Kingdom
St Georges Hospital
London, , United Kingdom
Countries
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Other Identifiers
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2019nCoV-503
Identifier Type: -
Identifier Source: org_study_id