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

NCT05468736 | Completed Phase 2 FDA Drug

• 1 other identifier: 2019nCoV-503
• Study Type: interventional
• Target: 3,600
• Locations: 10 countries
• Sites: 94

Brief 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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (7)

• Reactogenicity Incidence and Severity

  Reactogenicity incidence, duration, and severity (mild, moderate, severe, or potentially life-threatening) recorded by parent(s)/caregiver(s) on an electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).

  Day 0 to Day 7

• Incidence and Severity of Medically Attended Adverse Events (MAAEs)

  Incidence and severity of MAAEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.

  Day 0 to Day 28

• Incidence and Severity of Unsolicited Adverse Events (AEs)

  Incidence and severity of unsolicited AEs through 28 days after second injection of each set of vaccinations (initial and crossover), and after a booster dose.

  Day 0 to Day 28

• Incidence and Severity of MAAEs Attributed to Study Vaccine

  Incidence and severity of MAAEs attributed to study vaccine after initial vaccination at Day 0 through Month 24 or the EoS.

  Day 0 to Day 730

• Incidence and Severity of Serious Adverse Events (SAEs)

  Incidence and severity of SAEs after initial vaccination at Day 0 through Month 24 or the EoS.

  Day 0 to Day 730

• Incidence and Severity of Adverse Events of Special Interest (AESIs)

  Incidence and severity of AESIs (including multisystem inflammatory syndrome in children \[MIS-C\], and myocarditis and/or pericarditis) after initial vaccination at Day 0 through Month 24 or the EoS.

  Day 0 to Day 730

• Death due to any cause

  Death due to any cause occurring from Day 0 to EoS.

  Day 0 to Day 730

Secondary Outcomes (21)

• Participants with PCR positive mild, moderate or severe COVID-19 after the primary series of 2 doses

  Day 0 to Day 730

• Participants with PCR positive moderate or severe COVID-19 after the primary series of 2 doses

  Day 0 to Day 730

• Participants with diagnostic test - positive asymptomatic, mild, moderate or severe COVID-19 after the primary series of 2 doses

  Day 0 to Day 730

• Participants with diagnostic test - positive moderate or severe COVID-19 after the primary series of 2 doses

  Day 0 to Day 730

• Participants with PCR positive mild, moderate or severe COVID-19 after the booster dose

  Day 0 to Day 730

Study Arms (12)

Cohort-1(6 to < 12 y)-Part-1(Active Vaccine)

EXPERIMENTAL

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

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

Cohort-1(6 to < 12 y)-Part-1(Placebo)

PLACEBO COMPARATOR

Placebo (normal saline)

Other: Placebo

Cohort-1(6 to < 12 y)-Part-2(Active Vaccine)

EXPERIMENTAL

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

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

Cohort-1(6 to < 12 y)-Part-2(Placebo)

PLACEBO COMPARATOR

Placebo (normal saline)

Other: Placebo

Cohort-2(2 to < 6 y)-Part-1(Active Vaccine)

EXPERIMENTAL

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

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

Cohort-2(2 to < 6 y)-Part-1(Placebo)

PLACEBO COMPARATOR

Placebo (normal saline)

Other: Placebo

Cohort-2(2 to < 6 y)-Part-2(Active Vaccine)

EXPERIMENTAL

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

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

Cohort-2(2 to < 6 y)-Part-2(Placebo)

PLACEBO COMPARATOR

Placebo (normal saline)

Other: Placebo

Cohort-3(6 to < 24 m)-Part-1(Active Vaccine)

EXPERIMENTAL

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

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

Cohort-3(6 to < 24 m)-Part-1(Placebo)

PLACEBO COMPARATOR

Placebo (normal saline)

Other: Placebo

Cohort-3(6 to < 24 m)-Part-2

EXPERIMENTAL

NVX-CoV2373 (SARS-CoV-2 rS: 5 µg + Matrix-M adjuvant: 50 µg in 0.5 mL)

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

Cohort-3(6 to < 24 m)-Part-2(Placebo)

PLACEBO COMPARATOR

Placebo (normal saline)

Other: Placebo

Interventions

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

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.

Also known as: NVX-CoV2373

Cohort-1(6 to < 12 y)-Part-1(Active Vaccine); Cohort-1(6 to < 12 y)-Part-2(Active Vaccine); Cohort-2(2 to < 6 y)-Part-1(Active Vaccine); Cohort-2(2 to < 6 y)-Part-2(Active Vaccine); Cohort-3(6 to < 24 m)-Part-1(Active Vaccine); Cohort-3(6 to < 24 m)-Part-2

Placebo OTHER

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

Also known as: Sodium chloride 0.9% (BP, sterile)

Cohort-1(6 to < 12 y)-Part-1(Placebo); Cohort-1(6 to < 12 y)-Part-2(Placebo); Cohort-2(2 to < 6 y)-Part-1(Placebo); Cohort-2(2 to < 6 y)-Part-2(Placebo); Cohort-3(6 to < 24 m)-Part-1(Placebo); Cohort-3(6 to < 24 m)-Part-2(Placebo)

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.
• 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).
• 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.
• 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.
• Agree not to participate in another SARS-CoV-2 prevention trial for the duration of the study.

You may not qualify if:

• 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 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.
• Unstable acute or chronic illness. Criteria for unstable medical conditions include:
• Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
• 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.
• Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to the first study vaccination.
• History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
• 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.
• 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 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.
• 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.
• Received immunoglobulin or blood-derived products within 90 days prior to first study vaccination.
• 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).

Sponsors & Collaborators

• Novavax: lead

Study Sites (94)

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

Coast Clinical Research, LLC

Bellflower, California, 90706, United States

Location

Apex Research Group

Fair Oaks, California, 95628, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Orange County Research Institute

Ontario, California, 91762, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Clinical Research of California

Walnut Creek, California, 94598, United States

Location

Imagine Research of Palm Beach County

Boynton Beach, Florida, 33435, United States

Location

Palm Harbor Dermatology PA

Brandon, Florida, 33511, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Cordova Research Institute, LLC

Miami, Florida, 33155, United States

Location

ARS-Nona Pediatric Center

Orlando, Florida, 32829, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Tekton Research - Atlanta

Chamblee, Georgia, 30341, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Michael W. Simon, M.D., PSC

Lexington, Kentucky, 40517, United States

Location

Bluegrass Clinical Research, Inc./All Children Pediatrics

Louisville, Kentucky, 40243, United States

Location

Velocity Clinical Research - Covington, LA

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research - Covington

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research - Lafayette LA

Lafayette, Louisiana, 70508, United States

Location

Craig A. Spiegel, M.D.

Bridgeton, Missouri, 63044, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Meridian Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Be Well Clinical Studies, LLC

Lincoln, Nebraska, 68516, United States

Location

Corning Center for Clinical Research

Horseheads, New York, 14845, United States

Location

Velocity Clinical Research

Beachwood, Ohio, 44122, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Lynn Institute of Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Velocity Clinical Research Grants Pass

Grants Pass, Oregon, 97527, United States

Location

Tribe Clinical Research

Greenville, South Carolina, 29607, United States

Location

WR - ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Tekton Research Beaumont

Beaumont, Texas, 77706, United States

Location

PanAmerican Clinical Research

Brownsville, Texas, 78520, United States

Location

South Texas Clinical Research

Corpus Christi, Texas, 78404, United States

Location

Bay Colony Pediatrics

Dickinson, Texas, 77539, United States

Location

Trio Clinical Trials

Houston, Texas, 77008, United States

Location

Mercury Clinical Research

Houston, Texas, 77087, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Mercury Clinical Research - Pediatric Center

Richmond, Texas, 77469, United States

Location

Tekton Research

San Antonio, Texas, 78244, United States

Location

Alliance for Multispecialty Research

Layton, Utah, 84041, United States

Location

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

Roy, Utah, 84067, United States

Location

Velocity Clinical Research - West Jordan

West Jordan, Utah, 84088, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Fundacion Centro de Investigacion Clinica - CIC

Medellín, Antioquia, 50021, Colombia

Location

Clinica de la costa

Barranquilla, Atlántico, 80002, Colombia

Location

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

Puente Aranda, Bogota D.C., 111011, Colombia

Location

Centro de Atencion e Investigacion Medica - CAIMED

Yopal, Casanare Department, 850007, Colombia

Location

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, Santander Department, 681004, Colombia

Location

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

Cali, Valle del Cauca Department, 760042, Colombia

Location

PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia

Santo Domingo, Nacional, 10205, Dominican Republic

Location

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

Santo Domingo, Nacional, 10306, Dominican Republic

Location

MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian

Santo Domingo, Nacional, 10601, Dominican Republic

Location

Registrum Group (Hospital Regional Marcelino Velez)

Santo Domingo, Nacional, 11005, Dominican Republic

Location

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

Santo Domingo, Nacional, 11901, Dominican Republic

Location

Centro de Investigaciones Pediátricas (CIP)

Guatemala City, 01001, Guatemala

Location

SMI (Servicios Medicos Integrales)

Guatemala City, 01007, Guatemala

Location

CECLISA

Guatemala City, 01009, Guatemala

Location

DEMEDICA

San Pedro Sula, Cortés Department, 21104, Honduras

Location

Inverime S.A.

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Investigacion Sin Limites

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Panamerican Clinical Research S.A de C.V.

Guadalajara, Jalisco, 44670, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Tlalpan, Mexico City, 14080, Mexico

Location

Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)

Tlalpan, Mexico City, 14090, Mexico

Location

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

Cuernavaca, Morelos, 62290, Mexico

Location

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

Mérida, Yucatán, 97130, Mexico

Location

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

Querétaro, 76100, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, 54055, Mexico

Location

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

Veracruz, 91900, Mexico

Location

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

San Juan City, Batangas, 4226, Philippines

Location

Manila Doctors Hospital

Manila, National Capital Region, 1000, Philippines

Location

University of the Philippines - Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Location

National Children's Hospital

Quezon City, National Capital Region, 1102, Philippines

Location

FEU-NRMF

Quezon City, National Capital Region, 1118, Philippines

Location

Medical Mission Group Hospital-Lucban and Southern Luzon State University

Lucena City, Quezon, 4328, Philippines

Location

REIMED Riger Park

Boksburg, Gauteng, 1459, South Africa

Location

Setshaba Research Centre

Ga-Tshwene, Gauteng, 0152, South Africa

Location

Soweto Clinical Trials Centre

Johannesburg, Gauteng, 1818, South Africa

Location

WiWits RHI - Shandukani Research Centre

Johannesburg, Gauteng, 2001, South Africa

Location

Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital

Johannesburg, Gauteng, 2093, South Africa

Location

Wits Vida- Chris Hani Baragwanath Hospital

Soweto, Gauteng, 1862, South Africa

Location

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo, 0380, South Africa

Location

Tiervlei Trial Centre

Bellville, Western Cape, 7530, South Africa

Location

Be Part Yoluntu Centre - Paarl

Paarl, Western Cape, 7655, South Africa

Location

Stellenbosch University Worcester

Worcester, Western Cape, 6850, South Africa

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario de Torrejon

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Lakeside Healthcare Research

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

St Georges Hospital

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: July 22, 2022
• Primary Completion: January 16, 2024
• Study Completion: October 25, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

ZA (10); US (47); CO (6); ES (4); DO (5); HO (3); GU (3); PH (6); ME (8); GB (2)