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

January 22, 2024 updated by: Novavax

A Phase 2/3 Age De-escalating Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in Children 6 Months 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 and a booster dose of NVX CoV2373 given 21 days apart 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).

Study Overview

Detailed 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 and a booster dose of NVX CoV2373 given 21 days apart in pediatric participants (3 age cohorts). 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.

Study Type

Interventional

Enrollment (Estimated)

3600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Novavax Customer Service Center
  • Phone Number: 1-844-Novavax (668-2829)

Study Locations

    • Antioquia
      • Medellin, Antioquia, Colombia, 50021
        • Fundacion Centro de Investigacion Clinica - CIC
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 80002
        • Clinica de la Costa
    • Bogota
      • Puente Aranda, Bogota, Colombia, 111011
        • Centro de Atencion e Investigacion Medica S.A.S-CAIMED
    • Casanare
      • Yopal, Casanare, Colombia, 850007
        • Centro de Atencion e Investigacion Medica - CAIMED
    • Santander
      • Floridablanca, Santander, Colombia, 681004
        • Fundacion Oftalmologica De Santander - Foscal
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Centro de Estudios en Infectologia Pediatrica S.A.S.CEIP
    • Distrito Nacional
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10205
        • PROBEBE en Hospital Universitario Maternidad Nuestra Senora de la Altagracia
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10306
        • Instituto Dermatologico y Cirugia de Piel Dr. Huberto Bogaert Diaz IDCP
      • Santo Domingo, Distrito Nacional, Dominican Republic, 10601
        • MEDYVAC INTERNACIONAL SRL en Clinica Cruz Jiminian
      • Santo Domingo, Distrito Nacional, Dominican Republic, 11005
        • Registrum Group (Hospital Regional Marcelino Velez)
      • Santo Domingo, Distrito Nacional, Dominican Republic, 11901
        • Registrum Group (Hospital Materno Infantil San Lorenzo de Los Mina)
      • Guatemala, Guatemala, 01001
        • Centro de Investigaciones Pediátricas (CIP)
      • Guatemala, Guatemala, 01007
        • SMI (Servicios Medicos Integrales)
      • Guatemala, Guatemala, 01009
        • CECLISA
    • Cortés
      • San Pedro Sula, Cortés, Honduras, 21104
        • Demedica
    • Francisco Morazan
      • Tegucigalpa, Francisco Morazan, Honduras, 11101
        • Inverime S.A.
      • Tegucigalpa, Francisco Morazan, Honduras, 11101
        • Investigacion Sin Limites
      • Queretaro, Mexico, 76100
        • Panamerican Clinical Research Mexico S.A. de C.V. (Queretaro Site)
      • Tlalnepantla, Mexico, 54055
        • Clinical Research Institute S.C.
      • Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
    • Ciudad De Mexico
      • Tlalpan, Ciudad De Mexico, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Panamerican Clinical Research S.A de C.V.
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14090
        • Innovacion y Desarrollo en Ciencias de la Salud (IDeCSa)
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Panamerican Clinical Research, Mexico S.A de C.V.
    • Yucatan
      • Mérida, Yucatan, Mexico, 97130
        • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P.
    • Batangas
      • San Juan, Batangas, Philippines, 4226
        • University of the Philippines Manila - National Institutes of Health (NIH) - Institute of
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1000
        • Manila Doctors Hospital
      • Manila, Metro Manila, Philippines, 1000
        • University of the Philippines - Philippine General Hospital
      • Quezon City, Metro Manila, Philippines, 1102
        • National Children's Hospital
      • Quezon City, Metro Manila, Philippines, 1118
        • FEU-NRMF
    • Quezon
      • Lucena, Quezon, Philippines, 4328
        • Medical Mission Group Hospital-Lucban and Southern Luzon State University
    • Gauteng
      • Boksburg, Gauteng, South Africa, 1459
        • REIMED Riger Park
      • Ga-Tshwene, Gauteng, South Africa, 0152
        • Setshaba Research Centre
      • Johannesburg, Gauteng, South Africa, 1818
        • Soweto Clinical Trials Centre
      • Johannesburg, Gauteng, South Africa, 2001
        • WiWits RHI - Shandukani Research Centre
      • Johannesburg, Gauteng, South Africa, 2093
        • Wits Vida Nkanyezi Site- Rahima Moosa Mother and Child Hospital
      • Soweto, Gauteng, South Africa, 1862
        • Wits Vida- Chris Hani Baragwanath Hospital
    • Limpopo
      • Thabazimbi, Limpopo, South Africa, 0380
        • Limpopo Clinical Research Initiative
    • Western Cape
      • Bellville, Western Cape, South Africa, 7530
        • Tiervlei Trial Centre
      • Paarl, Western Cape, South Africa, 7655
        • Be Part Yoluntu Centre - Paarl
      • Worcester, Western Cape, South Africa, 6850
        • Stellenbosch University Worcester
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Complejo Hospitalario Universitario De Santiago
    • Madrid
      • Leganés, Madrid, Spain, 28911
        • Hospital Universitario Severo Ochoa
      • Torrejon de Ardoz, Madrid, Spain, 28850
        • Hospital Universitario de Torrejón
      • London, United Kingdom, SW17 0QT
        • St Georges Hospital
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • Lakeside Healthcare Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center
      • Bellflower, California, United States, 90706
        • Coast Clinical Research, LLC
      • Fair Oaks, California, United States, 95628
        • Apex Research Group
      • Long Beach, California, United States, 90815
        • ARK Clinical Research
      • Ontario, California, United States, 91762
        • Orange County Research Institute
      • San Diego, California, United States, 92123
        • California Research Foundation
      • Walnut Creek, California, United States, 94598
        • Clinical Research of California
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Imagine Research of Palm Beach County
      • Brandon, Florida, United States, 33511
        • Palm Harbor Dermatology PA
      • Jacksonville, Florida, United States, 32205
        • Westside Center for Clinical Research
      • Miami, Florida, United States, 33155
        • Cordova Research Institute, LLC
      • Orlando, Florida, United States, 32829
        • ARS-Nona Pediatric Center
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
      • Chamblee, Georgia, United States, 30341
        • Tekton Research - Atlanta
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Clinical Research
    • Kentucky
      • Lexington, Kentucky, United States, 40517
        • Michael W. Simon, M.D., PSC
      • Louisville, Kentucky, United States, 40243
        • Bluegrass Clinical Research, Inc./All Children Pediatrics
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Velocity Clinical Research - Covington
      • Covington, Louisiana, United States, 70433
        • Velocity Clinical Research - Covington, LA
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research - Lafayette LA
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Craig A. Spiegel, M.D.
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Be Well Clinical Studies, LLC
      • Lincoln, Nebraska, United States, 68510
        • Meridian Clinical Research
    • New York
      • Horseheads, New York, United States, 14845
        • Corning Center for Clinical Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Velocity Clinical Research
      • Dayton, Ohio, United States, 45409
        • Dayton Clinical Research
      • South Euclid, Ohio, United States, 44121
        • Senders Pediatrics
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Lynn Institute of Tulsa
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Velocity Clinical Research Grants Pass
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR - ClinSearch, LLC
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Beaumont, Texas, United States, 77706
        • Tekton Research Beaumont
      • Brownsville, Texas, United States, 78520
        • PanAmerican Clinical Research
      • Corpus Christi, Texas, United States, 78404
        • South Texas Clinical Research
      • Dickinson, Texas, United States, 77539
        • Bay Colony Pediatrics
      • Houston, Texas, United States, 77008
        • Trio Clinical Trials
      • Houston, Texas, United States, 77087
        • Mercury Clinical Research
      • Plano, Texas, United States, 75093
        • Research Your Health
      • Richmond, Texas, United States, 77469
        • Mercury Clinical Research - Pediatric Center
      • San Antonio, Texas, United States, 78244
        • Tekton Research
    • Utah
      • Layton, Utah, United States, 84041
        • Alliance for Multispecialty Research
      • Roy, Utah, United States, 84067
        • Alliance for Multispecialty Research c/o Wee Care Pediatrics - Roy
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical Research - West Jordan
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Originally Randomized to Vaccine, Immediate Booster Group
2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in Initial Vaccination Period.One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 201 in the Booster 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 Names:
  • NVX-CoV2373
In Booster Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0
Other Names:
  • NVX-CoV2373
Experimental: Originally Randomized to Vaccine, Delayed Booster Group
2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in the Initial Vaccination Period. 1 dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 201 or Day 229 and 1 dose of Placebo (Saline) on Day 201 or Day 229 in the Booster Vaccination Period.
In Booster Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0
Other Names:
  • NVX-CoV2373
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 Names:
  • Sodium chloride 0.9% (BP, sterile)
Experimental: Originally Randomized to Placebo
2 doses of Placebo (Saline),1 dose each on Days 0 and 21 in the Initial Vaccination Period. 2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) 1 dose each on Day 201 and Day 229 in Open-Label Crossover Vaccination Period. One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 409 in the Booster Vaccination Period.
In Booster Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0
Other Names:
  • NVX-CoV2373
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 Names:
  • Sodium chloride 0.9% (BP, sterile)
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 201 and Day 229 for the participants originally randomized to placebo.
Other Names:
  • NVX-CoV2373

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactogenicity Incidence and Severity
Time Frame: Day 0 to Day 7
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)
Time Frame: Day 0 to Day 28
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)
Time Frame: Day 0 to Day 28
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
Time Frame: Day 0 to Day 730
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)
Time Frame: Day 0 to Day 730
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)
Time Frame: Day 0 to Day 730
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
Time Frame: Day 0 to Day 730
Death due to any cause occurring from Day 0 to EoS.
Day 0 to Day 730

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with PCR positive mild, moderate or severe COVID-19 after the primary series of 2 doses
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline 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
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of PCR-positive moderate or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline, and by risk factors to develop 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
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of diagnostic test-positive asymptomatic, mild, moderate, or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline 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
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti NP serology at baseline, and by risk factors to develop 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
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of PCR-positive mild, moderate, or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose.
Day 0 to Day 730
Participants with PCR positive moderate or severe COVID-19 after the booster dose
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of PCR-positive moderate or severe COVID-19 overall and per age cohort, with or without positive anti-NP serology at baseline, and by risk factors to develop severe COVID-19 after the booster dose.
Day 0 to Day 730
Participants with diagnostic test - positive asymptomatic, mild, moderate or severe COVID-19 after the booster dose
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of diagnostic test-positive asymptomatic, mild, moderate, or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose.
Day 0 to Day 730
Participants with diagnostic test moderate or severe COVID-19 after the booster dose
Time Frame: Day 0 to Day 730
Incidence rate of participants with first episode of diagnostic test-positive moderate or severe COVID-19 (regardless of confirmatory test used, ie, PCR or rapid antigen test, and of testing location, ie, central or externally tested) overall and per age cohort, with or without positive anti-NP serology at baseline after the booster dose, and by risk factors to develop severe COVID-19.
Day 0 to Day 730
Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Time Frame: Day 0 to Day 730
Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic. Antibodies to SARS-CoV-2 NP at Days 0 and 35, at Crossover Visit 1, at Booster vaccination visit, and at Months 12 and 24 will be used to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Day 0 to Day 730
Neutralizing antibody response, post-booster, by age cohort,seronegative to anti-SARS-CoV-2 NP antibodies at baseline and pre-booster
Time Frame: Day 0 to Day 28
Neutralizing antibody response at 28 days post booster for pediatric participants in the Immunogenicity Population overall and by age cohort, seronegative to anti-SARS-CoV-2 NP antibodies at baseline and pre-booster, compared with that observed at 28 days post-booster vaccination in young adult participants 18 to < 26 years of age.
Day 0 to Day 28
Neutralizing antibody response, by age cohort, regardless of serostatus at baseline and pre-booster
Time Frame: Day 0 to Day 28
Neutralizing antibody response at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at baseline (Day 0).
Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein, post-booster, by age cohort, regardless of serostatus at baseline and pre-booster vaccination
Time Frame: Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster vaccination for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster vaccination, compared with that observed at 28 days post-booster vaccination in young adult participants 18 to < 26 years of age.
Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein, post booster, by age cohort, regardless of serostatus at baseline and pre-booster
Time Frame: Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at baseline (Day 0).
Day 0 to Day 28
Serum IgG levels to SARS-CoV-2 S protein , post booster, by age cohort, regardless of serostatus at baseline and pre-booster
Time Frame: Day 0 to Day 35
Serum IgG levels to SARS-CoV-2 S protein at 28 days post-booster for pediatric participants in the Immunogenicity Population overall and by age cohort, regardless of serostatus at baseline and pre-booster, compared with that observed in pediatric participants at Day 35,
Day 0 to Day 35
Percentage of pediatric participants by age cohort reporting SARS-CoV-2 infection (COVID-19) by severity
Time Frame: Day 28 to Day 730
Proportion of pediatric participants by age cohort reporting SARS-CoV-2 infection (COVID-19) from Day 28 through 6 months, from Day 28 through end of Month 12, from Day 28 through EOS, from 6 months through end of Month 12, and from 6 months through EOS, by severity classification.
Day 28 to Day 730
Neutralizing antibody response in the Immunogenicity Population
Time Frame: Day 35
Neutralizing antibody response at Day 35 for pediatric participants in the Immunogenicity Population by age cohort and with and without anti-SARS-CoV 2 NP antibodies at baseline.
Day 35
Serum IgG levels to SARS-CoV-2 S protein after second injection of the initial vaccination series
Time Frame: Day 35
Serum IgG levels to SARS-CoV-2 S protein 14 days after second injection of the initial vaccination series (Day 35) in pediatric participants in the Immunogenicity Population by age cohort and subsets with and without anti-NP antibodies at baseline.
Day 35
Treatment and severity of COVID 19 after a PCR-confirmed case
Time Frame: Day 0 to Day 730
Description of course, treatment and severity of COVID 19 reported after a PCR-confirmed case via the Case Form.
Day 0 to Day 730
Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Time Frame: Day 0 to Day 730
Antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic. Antibodies to SARS-CoV-2 NP at Days 0 and 35, at Crossover Visit 1, at Booster vaccination visit, and at Months 12 and 24 will be used to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Day 0 to Day 730
Serum IgG levels to SARS-CoV-2 S protein expressed as GMT
Time Frame: Day 180 to Day 730
Serum IgG levels to SARS-CoV-2 S protein at Months 6 (pre- booster), 7/8 (1-month post-booster), 12, and 24 post-vaccination with NVXCoV2373.
Day 180 to Day 730
MN titers to SARS-CoV-2 S protein expressed as GMT
Time Frame: Day 180 to Day 730
MN titers at Months 6 (pre- booster), 7/8 (1-month post-booster), 12, and 24 post-vaccination with NVXCoV2373.
Day 180 to Day 730

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Development, Novavax, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Actual)

November 13, 2023

Study Completion (Estimated)

September 8, 2025

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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