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A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

Primary Purpose

SARS-CoV Infection, Covid19

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo (Initial Vaccination Period)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
Placebo (Crossover Vaccination period)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)
Sponsored by
Novavax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV Infection focused on measuring Coronavirus, Prevent-19, Booster

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult Participants :

Each participant in the Adult Main Study and/or the Booster Amendment must meet all of the following criteria to be enrolled in this study:

  1. Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS CoV-2.
  2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
  3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) 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 medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
  4. Is medically stable, as determined 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 medically acceptable ranges prior to the first vaccination.
  5. Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up.
  6. For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination at the booster visit.

Pediatric Participants :

Each participant in the Pediatric Expansion and/or the Booster Amendment must meet all of the following criteria to be enrolled in this study:

  1. Pediatric participants 12 to < 18 years of age at screening, 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 medically acceptable ranges prior to the first vaccination.
  2. 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.
  3. 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 medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
  4. Agree to not participate in another SARS-CoV-2 prevention trial during the study follow-up.
  5. For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination.

Site-Specific Sub Study:

Each participant in the Substudy must meet all of the following criteria to be enrolled in this study:

  1. Be an active, enrolled participant in the 2019nCoV-301 study.
  2. Adults 18 years of age or older or adolescents 12 to < 18 years of age at initial screening for the parent study.
  3. Willing and able to give informed consent prior to substudy enrollment and to comply with extra study procedures.
  4. Documented receipt of the 2 doses of the primary series of NVX-CoV2373 and the booster (third dose) of NVX-CoV2373 in the parent protocol. The booster dose must have been administered at least 6 months prior to entering the substudy.
  5. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile or postmenopausal) must agree to be heterosexually inactive from at least 28 days prior to entering and through the end of the substudy OR agree to consistently use a medically acceptable method of contraception for the 28 days of follow-up for the substudy.
  6. Is medically stable, as determined by the investigator (based on review of health status, vital signs (to include body temperature) and targeted physical examination (if medically indicated by reported symptoms). Vital signs must be within medically acceptable ranges prior to administration of study vaccination.
  7. Agree to not participate in any other non-NVX-CoV2373 study during the substudy.

Note: For participants who develop COVID-19, anti-SARS-CoV-2 therapy (approved, authorized or investigational) is permitted.

Exclusion Criteria:

Adult and adolescent participants meeting any of the following criteria will be excluded from the study:

  1. 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 diagnosis of a new condition.

    Note: Well-controlled human immunodeficiency virus [HIV] with undetectable HIV 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.

  2. Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to first study vaccination.
  3. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. A previous diagnosis of COVID-19 during participation in this trial is not exclusionary for the Booster Amendment.
  4. Received any vaccine within 4 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (i.e., 28 days after second vaccination), except for influenza vaccination, which may be received ≥ 4 days prior to or ≥ 7 days after either study vaccination. Rabies vaccine, at any time it is medically indicated, is not exclusionary. Prior receipt of another approved or authorized COVID-19 vaccine prior to booster injection is not exclusionary in the Booster Amendment. Such participants must provide documentation of vaccine and date(s) of administration.
  5. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis, including stable diabetes mellitus) are NOT excluded.
  6. Chronic administration (defined as > 14 continuous days) of immunosuppressant or systemic glucocorticoids causing clinically significant immunocompromise, within 90 days prior to first study vaccination and/or third (booster) 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.
  7. Received immunoglobulin or blood-derived products, within 90 days prior to first study vaccination and/or third (booster) vaccination.
  8. Active cancer (malignancy) on chemotherapy that is judged to cause clinically significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). This criterion is not applicable to participants diagnosed during participation in this trial who accept participation in the Booster Amendment.
  9. Any known allergies to products contained in the investigational product.
  10. Participants who are breastfeeding, pregnant, or who plan to become pregnant within 3 months following last study vaccination.
  11. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.
  12. Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
  13. Current participation in any other COVID-19 prevention clinical trial.
  14. Adult participants who have not received a full dose of any authorized/approved COVID-19 vaccine and are unable to provide valid documentation of vaccination will be excluded from the Booster Amendment.

Adult and adolescent participants meeting any of the following criteria will be excluded from the substudy:

  1. History of laboratory-confirmed (by PCR or other antigen testing) COVID-19 infection ≤ 4 months prior to entering the substudy.
  2. Known to be clinically significantly immunocompromised.
  3. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to entering substudy.
  4. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of substudy.
  5. History of confirmed myocarditis and/or pericarditis since enrollment to the parent study.
  6. Any condition that, in the opinion of the investigator, might pose a health risk to the participant, interfere with protocol compliance or interfere with evaluation of the trial vaccine.
  7. Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the substudy).

Sites / Locations

  • Alabama Clinical Therapeutics, Llc (Pediatric Site)
  • Accel Research Sites (Adult Site)
  • Central Research Associates, Inc (Pediatric Site)
  • The Pain Center of Arizona (Adult Site)
  • Foothills Research Center-CCT Research (Pediatric Site)
  • Alliance for Multispecialty Research, LLC (Adult Site)
  • Lynn Institute of the Ozarks (Adult Site)
  • Preferred Research Partners, Inc. (Adult Site)
  • Anaheim Clinical Trials (Adult Site)
  • Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site)
  • Coast Clinical Research, LLC (Pediatric Site)
  • Velocity Clinical Research (Pediatric & Adult Site)
  • Premier Health Research Center, Llc (Pediatric Site)
  • eStudySite - Corporate Offices (Adult Site)
  • Paradigm Clinical Research Centers, Inc (Pediatric Site)
  • WR-PRI, LLC (Adult Site)
  • National Research Institute (Pediatric & Adult Site)
  • Orange County Research Institute (Pediatric Site)
  • Empire Clinical Research (Pediatric & Adult Site)
  • University of California Davis Health (Pediatric & Adult Site)
  • Benchmark Research (Pediatric & Adult Site)
  • California Research Foundation (Pediatric & Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • Dignity Health Medical Foundation - Woodland (Adult Site)
  • University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site)
  • Lynn Institute of the Rockies (Adult Site)
  • Meridian Clinical Research (Pediatric Site)
  • Howard University Hospital Howard/ University College of Medicine (Adult Site)
  • University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site)
  • SIMED Health, LLC / SIMED Research (Adult Site)
  • M D Clinical (Adult Site)
  • Jacksonville Center for Clinical Research (Pediatric & Adult Site)
  • Meridien Research/Accel Research (Pediatric & Adult site)
  • Miami Veterans Affairs Medical Center (Adult Site)
  • Suncoast Research Associates, LLC (Adult Site)
  • Acevedo Clinical Research Associates (Pediatric Site)
  • Suncoast Research Associates, LLC (Adult Site)
  • Clinical Neuroscience Solutions Inc (Pediatric & Adult Site)
  • Headlands Research Orlando (Adult Site)
  • Synexus Clinical Research US, Inc (Adult Site)
  • Asclepes Research Centers (Adult & Pediatric Site)
  • Tampa Heart & Cardiovascular Center (Adult Site)
  • Office Of John S. Curran MD (Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • Comprehensive Clinical Trials, Llc (Pediatric & Adult site)
  • Emory University Hospital (Adult Site)
  • Atlanta - Morehouse School of Medicine (Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • Atlanta Center for Medical Research (Adult Site)
  • Tekton Research, Inc. (Pediatric Site)
  • Columbus Regional Research Institute (Adult Site)
  • Clinical Research Atlanta (Adult Site)
  • Advanced Clinical Research (Pediatric & Adult Site)
  • Synexus Clinical Research US, Inc (Adult Site)
  • Cedar Crosse Research Center (Adult Site)
  • Providea Health Partners LLC (Adult Site)
  • Synexus USA (Adult Site)
  • Buynak Clinical Research, P.C. (Pediatric & Adult Site)
  • The University of Iowa Hospitals & Clinics (Adult Site)
  • Meridian Clinical Research (Adult Site)
  • Johnson County Clin-Trials, Inc. (Pediatric & Adult Site)
  • Alliance for Multispecialty Research (AMR) (Pediatric Site)
  • AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte)
  • Kentucky Pediatric/Adult Research (Pediatric Site)
  • Brownsboro Park Pediatrics (Pediatric Site)
  • Meridian Clinical Research Baton Rouge (Pediatric Site)
  • Meridian Clinical Research, LLC (Adult Site)
  • Med Pharmics, LLC (Pediatric & Adult Site)
  • Willis-Knighton Physician Network (Adult Site)
  • c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site)
  • Beth Israel Deaconess Medical Center (Adult Site)
  • VA Ann Arbor Healthcare System (Adult Site)
  • Wayne State University/ Children's Hospital of Michigan (Adult Site)
  • University of Minnesota (Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • MedPharmics, LLC-Biloxi (Pediatric & Adult Site)
  • The Curators of University of Missouri (Adult Site)
  • Sundance Clinical Research, LLC (Pediatric & Adult Site)
  • Meridian Clinical Research (Adult & Pediatric Site)
  • Meridian Clinical Research Associates, LLC (Pediatric & Adult Site)
  • University Of Nebraska Medical Center (Pediatric & Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • Clinical Research Center of Nevada (Pediatric Site)
  • Clinical Research Consortium (Adult Site)
  • Meridian Clinical Research (Pediatric Site)
  • Stony Brook Responder Vaccine Program (Adult Site)
  • Weill Cornell Chelsea CRS (Adult Site)
  • Rochester Clinical Research (Pediatric & Adult Site)
  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site)
  • The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site)
  • M3-Emerging Medical Research, LLC (Pediatric & Adult Site)
  • Carolina Institute for Clinical Research (Adult Site)
  • Carolina Institute for Clinical Research (Adult Site)
  • Womack Army Medical Center (Adult Site)
  • M3 Wake Research, Inc (Adult Site)
  • PMG Research of Rocky Mount, LLC (Adult Site)
  • Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site)
  • PMG Research of Wilmington, LLC (Adult Site)
  • Synexus Clinical Research, US, Inc. (Adult Site)
  • Sterling Research Group, Ltd. (Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • Sterling Research Group, Ltd (Pediatric & Adult Site)
  • Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site)
  • Velocity Clinical Research (Pediatric & Adult Site)
  • Aventiv Research Inc (Pediatric Site)
  • Medical Research International (Adult Site)
  • Lynn Health Science Institute (Pediatric & Adult Site)
  • Velocity Clinical Research (Pediatric & Adult Site)
  • Preferred Primary Care Physicians, Inc. (Pediatric Site)
  • The Miriam Hospital (TMH) (Adult Site)
  • Omega Medical Research, Providence (Pediatric & Adult Site)
  • Synexus Clinical Research US, Inc. (Adult Site)
  • Medical University of South Carolina, SCTR Research Nexus (Adult Site)
  • Coastal Carolina Research Center (Pediatric Site)
  • Spartanburg Medical Research (Pediatric Site)
  • American Indian Clinical Trials Research Network (Pediatric & Adult Site)
  • Accellacare of Bristol (Pediatric & Adult Site)
  • WR Clinsearch, LLC (Pediatric & Adult Site)
  • Holston Medical Group (Pediatric Site)
  • Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site)
  • Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site)
  • Clinical Research Associates (Pediatric Site)
  • Clinical and Translational Research Center at Meharry Medical College (Adult Site)
  • Benchmark Research (Pediatric & Adult Site)
  • Ventavia Research Group, LLC (Pediatric Site)
  • Benchmark Research (Pediatric & Adult Site)
  • Ventavia Research Group, LLC (Pediatric Site)
  • Baylor College of Medicine (Adult Site)
  • DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site)
  • Texas Center for Drug Development, Inc (Pediatric & Adult Site)
  • The University Of Texas Medical Branch (Utmb) (Pediatric Site)
  • Centex Studies, Inc (Adult Site)
  • Research Your Health (Pediatric & Adult site)
  • AES San Antonio (Adult Site)
  • University of Texas Health Science Center San Antonio (Adult Site)
  • Tekton Research, Inc. (Pediatric Site)
  • DM Clinical Research (Pediatric & Adult Site)
  • Wee Care Pediatrics (Pediatric Site)
  • Wee Care Pediatrics (Pediatric Site)
  • Advanced Clinical Research (Adult Site)
  • Pediatric Research of Charlottesville, LLC (Pediatric Site)
  • Health Research of Hampton Roads, Inc (Pediatric & Adult Site)
  • MultiCare Institute for Research & Innovation (Adult Site)
  • University of Washington VTEU (Adult Site)
  • PanAmerican Clinical Research Mexico S.A de C.V (Adult Site)
  • Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site)
  • PanAmerican Clinical Research Mexico (Adult Site)
  • Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site)
  • CAIMED Investigacion en Salud S.A de C.V (Adult Site)
  • Caimed Investigacion en Salud S.A. de C.V. (Adult Site)
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site)
  • FAICIC S. DE R.L. DE C.V. (Adult Site)
  • Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site)
  • University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial vaccination)

Placebo (Initial Vaccination)

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination)

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)

SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster)

Placebo (Crossover Vaccination)

Arm Description

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.

2 doses of Placebo (Saline), 1 dose each on Days 0 and 21in Initial Vaccination Period.

One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 or Day 21 in Crossover Vaccination Period.

One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Booster Vaccination Period.

One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Second Booster Vaccination Period.

One dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.

Outcomes

Primary Outcome Measures

Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)
Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Pediatric Expansion: Reactogenicity Incidence and Severity
Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Pediatric Expansion: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49
Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Pediatric Expansion: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49
Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Pediatric Expansion: Incidence and Severity of Serious Adverse Events (SAEs) Through Specified Time Points
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Pediatric Expansion: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Specified Time Points
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Pediatric Expansion: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Pediatric Expansion: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Number of participants with antibodies to SARS-CoV-2 NP at Day 35 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Pediatric Expansion: Deaths Due to Any Cause
Number of participants who died during the study due to any cause.

Secondary Outcome Measures

Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19
Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19
Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)
Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)
Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Serum IgG Antibody Levels Expressed as GMFRs
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points
Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points
Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.
Adult Main Study and Pediatric Expansion: Description of Course, Treatment and Severity of COVID-19
Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.
Adult Main Study: Reactogenicity Incidence and Severity
Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Adult Main Study: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49
Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Adult Main Study: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49
Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 months.
Adult Main Study: Incidence and Severity of Serious Adverse Events (SAEs) Attributed to Study Vaccine Through Specified Time Points
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 months.
Adult Main Study: Incidence and Severity of Adverse Events of Special Interest (AESIs) Attributed to Study Vaccine Through Specified Time Points
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 months.
Adult Main Study: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Adult Main Study: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or at specified time points through EoS to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point
Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Adult Main Study: IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination
The ratio of geometric mean IgG antibody concentrations will be computed at Day 35 for the new manufacturing process versus the old manufacturing process using the data collected from 300 active vaccine recipients 18 to ≤ 64 years of age enrolled at selected study sites.
Adult Main Study : Deaths Due to Any Cause
Number of participants who died during the study due to any cause.
Adult Main Study and Pediatric Expansion: Participants with 1st episode of positive Polymerase Chain Reaction (PCR) for Coronavirus Disease 2019 (COVID-19) due to a variant not considered as a "variant of concern/interest"
Number of participants with first episode of PCR-positive COVID-19, as defined under the primary endpoint, shown by gene sequencing to represent a variant not considered as a "variant of concern/interest" according to the CDC Variants Classification.

Full Information

First Posted
October 30, 2020
Last Updated
August 10, 2023
Sponsor
Novavax
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT04611802
Brief Title
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
Official Title
A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2020 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novavax
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)
Detailed Description
This is a Phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants ≥ 18 years of age (Adult Main Study) and adolescent participants 12 to <18 years (Pediatric Expansion). Additionally, a Booster Amendment will allow for the evaluation of a booster dose of SARS-CoV-2 rS with Matrix-M1 adjuvant in participants who completed the primary series of active vaccine in the Adult Main Study or Pediatric Expansion, as well as in participants who previously completed the primary series of an authorized/approved COVID-19 vaccine. Additionally, a sub-study conducted at specific sites will allow for the evaluation of a second booster dose of SARS-CoV-2 rS with Matrix-M1 adjuvant in participants who completed the primary series of active vaccine in the Adult Main Study and Pediatric Expansion as well as a booster dose in the Booster Amendment of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV Infection, Covid19
Keywords
Coronavirus, Prevent-19, Booster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial vaccination)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Initial Vaccination)
Arm Type
Placebo Comparator
Arm Description
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21in Initial Vaccination Period.
Arm Title
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination)
Arm Type
Experimental
Arm Description
One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 or Day 21 in Crossover Vaccination Period.
Arm Title
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
Arm Type
Experimental
Arm Description
One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Booster Vaccination Period.
Arm Title
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster)
Arm Type
Experimental
Arm Description
One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Second Booster Vaccination Period.
Arm Title
Placebo (Crossover Vaccination)
Arm Type
Placebo Comparator
Arm Description
One dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Other Intervention Name(s)
NVX-CoV2373
Intervention Description
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
Intervention Type
Other
Intervention Name(s)
Placebo (Initial Vaccination Period)
Other Intervention Name(s)
Sodium chloride 0.9% (BP, sterile)
Intervention Description
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
Other Intervention Name(s)
NVX-CoV2373
Intervention Description
In Crossover 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 or Day 21
Intervention Type
Other
Intervention Name(s)
Placebo (Crossover Vaccination period)
Other Intervention Name(s)
Sodium chloride 0.9% (BP, sterile)
Intervention Description
In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of placebo (0.5 mL) on Day 0 or Day 21
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
Other Intervention Name(s)
NVX-CoV2373
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)
Other Intervention Name(s)
NVX-CoV2373
Intervention Description
In Second 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
Primary Outcome Measure Information:
Title
Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)
Description
Number of participants with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Time Frame
Day 28 to Day 750
Title
Pediatric Expansion: Reactogenicity Incidence and Severity
Description
Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Time Frame
Day 0 to Day 27
Title
Pediatric Expansion: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49
Description
Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Time Frame
Day 0 to Day 49
Title
Pediatric Expansion: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49
Description
Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Time Frame
Day 0 to Day 49
Title
Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points
Description
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Time Frame
Day 90 to Day 750
Title
Pediatric Expansion: Incidence and Severity of Serious Adverse Events (SAEs) Through Specified Time Points
Description
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Time Frame
Day 90 to Day 750
Title
Pediatric Expansion: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Specified Time Points
Description
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 and 6 months.
Time Frame
Day 90 to Day 750
Title
Pediatric Expansion: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Description
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Time Frame
Day 90 to Day 750
Title
Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Description
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Time Frame
Day 90 to Day 750
Title
Pediatric Expansion: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24
Description
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Time Frame
Day 90 to Day 750
Title
Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Description
Number of participants with antibodies to SARS-CoV-2 NP at Day 35 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Time Frame
Day 35
Title
Pediatric Expansion: Deaths Due to Any Cause
Description
Number of participants who died during the study due to any cause.
Time Frame
Day 0 to Day 750
Secondary Outcome Measure Information:
Title
Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19
Description
Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Time Frame
Day 28 to Day 750
Title
Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19
Description
Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.
Time Frame
Day 28 to Day 750
Title
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)
Description
Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)
Description
Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs
Description
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Serum IgG Antibody Levels Expressed as GMFRs
Description
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs
Description
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and at specified time points through EoS.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs
Description
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and at specified time points through EoS.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points
Description
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.
Time Frame
Day 165 to Day 750
Title
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points
Description
Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.
Time Frame
Day 165 to Day 750
Title
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points
Description
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.
Time Frame
Day 165 to Day 750
Title
Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points
Description
Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.
Time Frame
Day 165 to Day 750
Title
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points
Description
Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.
Time Frame
Day 165 to Day 750
Title
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points
Description
Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.
Time Frame
Day 165 to Day 750
Title
Adult Main Study and Pediatric Expansion: Description of Course, Treatment and Severity of COVID-19
Description
Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.
Time Frame
Day 28 to Day 750
Title
Adult Main Study: Reactogenicity Incidence and Severity
Description
Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).
Time Frame
Day 0 to Day 27
Title
Adult Main Study: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49
Description
Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Time Frame
Day 0 to Day 49
Title
Adult Main Study: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49
Description
Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).
Time Frame
Day 0 to Day 49
Title
Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points
Description
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 months.
Time Frame
Day 90 to Day 750
Title
Adult Main Study: Incidence and Severity of Serious Adverse Events (SAEs) Attributed to Study Vaccine Through Specified Time Points
Description
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 months.
Time Frame
Day 90 to Day 750
Title
Adult Main Study: Incidence and Severity of Adverse Events of Special Interest (AESIs) Attributed to Study Vaccine Through Specified Time Points
Description
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 months.
Time Frame
Day 90 to Day 750
Title
Adult Main Study: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Description
Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Time Frame
Day 90 to Day 750
Title
Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
Description
Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Time Frame
Day 360 to Day 750
Title
Adult Main Study: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24
Description
Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.
Time Frame
Day 360 to Day 750
Title
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
Description
Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or at specified time points through EoS to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point
Description
Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Time Frame
Day 0 to Day 750
Title
Adult Main Study: IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination
Description
The ratio of geometric mean IgG antibody concentrations will be computed at Day 35 for the new manufacturing process versus the old manufacturing process using the data collected from 300 active vaccine recipients 18 to ≤ 64 years of age enrolled at selected study sites.
Time Frame
Day 35 after the first crossover vaccination
Title
Adult Main Study : Deaths Due to Any Cause
Description
Number of participants who died during the study due to any cause.
Time Frame
Day 0 to Day 750
Title
Adult Main Study and Pediatric Expansion: Participants with 1st episode of positive Polymerase Chain Reaction (PCR) for Coronavirus Disease 2019 (COVID-19) due to a variant not considered as a "variant of concern/interest"
Description
Number of participants with first episode of PCR-positive COVID-19, as defined under the primary endpoint, shown by gene sequencing to represent a variant not considered as a "variant of concern/interest" according to the CDC Variants Classification.
Time Frame
Day 28 to Day 750
Other Pre-specified Outcome Measures:
Title
Booster Amendment: Participants with symptomatic mild, moderate or severe COVID-19
Description
First episode of PCR-positive mild, moderate, or severe COVID-19 occurring ≥ 7 days after the third (booster) vaccine dose.
Time Frame
Day 0 to Day 7
Title
Booster Amendment: Participants with PCR positive moderate-to-severe COVID-19
Description
First episode of PCR-positive moderate-to-severe COVID-19 occurring ≥ 7 days after the third (booster) vaccine dose.
Time Frame
Day 0 to Day 7
Title
Booster Amendment: Participants with PCR positive COVID-19 due to a variant not considered "variant of interest/concern"
Description
First episode of PCR-positive COVID-19 occurring ≥7 days after the third (booster) vaccine dose and shown by gene sequencing to represent a variant not considered as a "variant of concern/interest" according to the CDC Variants Classification
Time Frame
Day 0 to Day 7
Title
Booster Amendment: Participants with PCR positive COVID-19 due to a 'variant of concern/interest"
Description
First episode of PCR-positive COVID-19 occurring ≥7 days after the third (booster) vaccine dose, and shown by gene sequencing to represent a "variant of concern/interest" according to the CDC Variants Classification.
Time Frame
Day 0 to Day 7
Title
Booster Amendment: Neutralizing antibody activity expressed as GMT
Description
Neutralizing antibody titers from Immunogenicity Population immediately prior and at 28 days after administration of the third (booster) vaccine dose expressed as GMT.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: Neutralizing antibody activity expressed as GMFR
Description
Neutralizing antibody titers from Immunogenicity Population immediately prior and at 28 days after administration of the third (booster) vaccine dose expressed as GMFR.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: Serum IgG antibody levels expressed as GMT
Description
Serum levels of IgG to SARS-CoV-2 S protein from Immunogenicity Population immediately prior and at 28 days after administration of the third (booster) vaccine dose expressed as GMT.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: Serum IgG antibody levels expressed as GMFR
Description
Serum levels of IgG to SARS-CoV-2 S protein from Immunogenicity Population immediately prior and at 28 days after administration of the third (booster) vaccine dose expressed as GMFR.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: hACE2 receptor binding inhibition assay expressed as GMT
Description
hACE2 inhibition titers from Immunogenicity Population immediately prior and at 28 days after administration of the third (booster) vaccine dose expressed as GMT.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: hACE2 receptor binding inhibition assay expressed as GMFR
Description
hACE2 inhibition titers from Immunogenicity Population immediately prior and at 28 days after administration of the third (booster) vaccine dose expressed as GMFR.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: Incidence and severity of unsolicited AE's
Description
Incidence and severity of unsolicited AEs through 28 days after the third (booster) vaccine dose.
Time Frame
Day 0 to Day 28
Title
Booster Amendment: Incidence and severity of MAAE's, SAE's and AESI's
Description
Incidence and severity of MAAEs attributed to study vaccine, SAEs and AESIs through EoS.
Time Frame
Day 0 to Day 720
Title
Booster Amendment: Description of course, treatment and severity of COVID-19
Description
Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case occurring ≥7 days after the third (booster) vaccine dose via the Endpoint Form.
Time Frame
Day 0 to Day 7
Title
Booster Amendment: Reactogenicity Incidence and Severity
Description
Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of the third (booster) vaccination and subsequent 6 days.
Time Frame
Day0 to Day 7
Title
Booster Amendment: Deaths Due to Any Cause
Description
Number of participants who died during the study due to any cause.
Time Frame
Day 0 to Day 720
Title
Site Specific Sub Study: Serum IgG to the SARS-CoV-2 spike protein expressed as GMEU
Description
IgG geometric mean ELISA unit concentrations (EU/ml) to the SARS-CoV-2 spike protein at Day 28 following the second booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: Serum IgG antibody expressed as GMFR
Description
IgG Geometric Mean Fold Rises (GMFR) at Day 28 post second booster dose relative to Day 28 post-first booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: Serum IgG to the SARS-CoV-2 spike protein expressed as SPR
Description
Proportion of participants who achieve seroresponse (≥ 4-fold increase from pre-second booster baseline) in IgG ELISA unit concentrations to the SARS-CoV-2 spike protein at Day 28 post second booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs
Description
hACE2 inhibition assay titers (GMTs) at Day 28 post second booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: hACE2 Receptor Binding Inhibition Assay Expressed as GMFR
Description
hACE2 GMFR at Day 28 post second booster dose relative to Day 28 post-first booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: hACE2 Receptor Binding Inhibition Assay Expressed as SPR
Description
Proportion of participants who achieve seroresponse (≥ 4-fold increase from pre-second booster baseline) in hACE2 inhibition assay titers at Day 28 post-second booster dose.Incidence, severity, and duration of solicited adverse events for the 7 days period following the second booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: Microneutralization assay (MN) titers to the SARS-CoV-2 wild type virus expressed as GMTs
Description
MN50 geometric mean titers to the SARS-CoV-2 wild-type virus at Day 28 post second booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: Microneutralization assay (MN) titers to the SARS-CoV-2 wild type virus expressed as GMFR
Description
MN50 GMFR at Day 28 post second booster dose relative to Day 28 post-first booster dose.
Time Frame
Day 28
Title
Site Specific Sub Study: Microneutralization assay (MN) titers to the SARS-CoV-2 wild type virus expressed as SPR
Description
Proportion of participants who achieve seroresponse (≥ 4-fold increase from pre-second booster baseline) in MN50 titers concentrations to the wild-type virus at Day 28 post second booster dose.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult Participants : Each participant in the Adult Main Study and/or the Booster Amendment must meet all of the following criteria to be enrolled in this study: Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS CoV-2. Willing and able to give informed consent 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 [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) 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 medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination. Is medically stable, as determined 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 medically acceptable ranges prior to the first vaccination. Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up. For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination at the booster visit. Pediatric Participants : Each participant in the Pediatric Expansion and/or the Booster Amendment must meet all of the following criteria to be enrolled in this study: Pediatric participants 12 to < 18 years of age at screening, 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 medically acceptable ranges prior to the first vaccination. 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 medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination. Agree to not participate in another SARS-CoV-2 prevention trial during the study follow-up. For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination. Site-Specific Sub Study: Each participant in the Substudy must meet all of the following criteria to be enrolled in this study: Be an active, enrolled participant in the 2019nCoV-301 study. Adults 18 years of age or older or adolescents 12 to < 18 years of age at initial screening for the parent study. Willing and able to give informed consent prior to substudy enrollment and to comply with extra study procedures. Documented receipt of the 2 doses of the primary series of NVX-CoV2373 and the booster (third dose) of NVX-CoV2373 in the parent protocol. The booster dose must have been administered at least 6 months prior to entering the substudy. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile or postmenopausal) must agree to be heterosexually inactive from at least 28 days prior to entering and through the end of the substudy OR agree to consistently use a medically acceptable method of contraception for the 28 days of follow-up for the substudy. Is medically stable, as determined by the investigator (based on review of health status, vital signs (to include body temperature) and targeted physical examination (if medically indicated by reported symptoms). Vital signs must be within medically acceptable ranges prior to administration of study vaccination. Agree to not participate in any other non-NVX-CoV2373 study during the substudy. Note: For participants who develop COVID-19, anti-SARS-CoV-2 therapy (approved, authorized or investigational) is permitted. Exclusion Criteria: Adult and adolescent participants meeting any of the following criteria will be excluded from the study: 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 diagnosis of a new condition. Note: Well-controlled human immunodeficiency virus [HIV] with undetectable HIV 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 first study vaccination. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. A previous diagnosis of COVID-19 during participation in this trial is not exclusionary for the Booster Amendment. Received any vaccine within 4 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (i.e., 28 days after second vaccination), except for influenza vaccination, which may be received ≥ 4 days prior to or ≥ 7 days after either study vaccination. Rabies vaccine, at any time it is medically indicated, is not exclusionary. Prior receipt of another approved or authorized COVID-19 vaccine prior to booster injection is not exclusionary in the Booster Amendment. Such participants must provide documentation of vaccine and date(s) of administration. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis, including stable diabetes mellitus) are NOT excluded. Chronic administration (defined as > 14 continuous days) of immunosuppressant or systemic glucocorticoids causing clinically significant immunocompromise, within 90 days prior to first study vaccination and/or third (booster) 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. Received immunoglobulin or blood-derived products, within 90 days prior to first study vaccination and/or third (booster) vaccination. Active cancer (malignancy) on chemotherapy that is judged to cause clinically significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). This criterion is not applicable to participants diagnosed during participation in this trial who accept participation in the Booster Amendment. Any known allergies to products contained in the investigational product. Participants who are breastfeeding, pregnant, or who plan to become pregnant within 3 months following last study vaccination. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results. Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study). Current participation in any other COVID-19 prevention clinical trial. Adult participants who have not received a full dose of any authorized/approved COVID-19 vaccine and are unable to provide valid documentation of vaccination will be excluded from the Booster Amendment. Adult and adolescent participants meeting any of the following criteria will be excluded from the substudy: History of laboratory-confirmed (by PCR or other antigen testing) COVID-19 infection ≤ 4 months prior to entering the substudy. Known to be clinically significantly immunocompromised. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to entering substudy. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of substudy. History of confirmed myocarditis and/or pericarditis since enrollment to the parent study. Any condition that, in the opinion of the investigator, might pose a health risk to the participant, interfere with protocol compliance or interfere with evaluation of the trial vaccine. Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the substudy).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development
Organizational Affiliation
Novavax, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics, Llc (Pediatric Site)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Accel Research Sites (Adult Site)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Central Research Associates, Inc (Pediatric Site)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
The Pain Center of Arizona (Adult Site)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Foothills Research Center-CCT Research (Pediatric Site)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC (Adult Site)
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Lynn Institute of the Ozarks (Adult Site)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Preferred Research Partners, Inc. (Adult Site)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Anaheim Clinical Trials (Adult Site)
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site)
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Coast Clinical Research, LLC (Pediatric Site)
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Velocity Clinical Research (Pediatric & Adult Site)
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Premier Health Research Center, Llc (Pediatric Site)
City
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
eStudySite - Corporate Offices (Adult Site)
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc (Pediatric Site)
City
La Mesa
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
WR-PRI, LLC (Adult Site)
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
National Research Institute (Pediatric & Adult Site)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Orange County Research Institute (Pediatric Site)
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Empire Clinical Research (Pediatric & Adult Site)
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
University of California Davis Health (Pediatric & Adult Site)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Benchmark Research (Pediatric & Adult Site)
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States
Facility Name
California Research Foundation (Pediatric & Adult Site)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Dignity Health Medical Foundation - Woodland (Adult Site)
City
Woodland
State/Province
California
ZIP/Postal Code
95695
Country
United States
Facility Name
University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lynn Institute of the Rockies (Adult Site)
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Meridian Clinical Research (Pediatric Site)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Howard University Hospital Howard/ University College of Medicine (Adult Site)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site)
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
SIMED Health, LLC / SIMED Research (Adult Site)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
M D Clinical (Adult Site)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Jacksonville Center for Clinical Research (Pediatric & Adult Site)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Meridien Research/Accel Research (Pediatric & Adult site)
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Miami Veterans Affairs Medical Center (Adult Site)
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Suncoast Research Associates, LLC (Adult Site)
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Acevedo Clinical Research Associates (Pediatric Site)
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Suncoast Research Associates, LLC (Adult Site)
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc (Pediatric & Adult Site)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Headlands Research Orlando (Adult Site)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Synexus Clinical Research US, Inc (Adult Site)
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Asclepes Research Centers (Adult & Pediatric Site)
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Tampa Heart & Cardiovascular Center (Adult Site)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Office Of John S. Curran MD (Adult Site)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Comprehensive Clinical Trials, Llc (Pediatric & Adult site)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Emory University Hospital (Adult Site)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Atlanta - Morehouse School of Medicine (Adult Site)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310-1495
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Medical Research (Adult Site)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Tekton Research, Inc. (Pediatric Site)
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Columbus Regional Research Institute (Adult Site)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Clinical Research Atlanta (Adult Site)
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research (Pediatric & Adult Site)
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Synexus Clinical Research US, Inc (Adult Site)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Cedar Crosse Research Center (Adult Site)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Providea Health Partners LLC (Adult Site)
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Synexus USA (Adult Site)
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Buynak Clinical Research, P.C. (Pediatric & Adult Site)
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
The University of Iowa Hospitals & Clinics (Adult Site)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Meridian Clinical Research (Adult Site)
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Johnson County Clin-Trials, Inc. (Pediatric & Adult Site)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Alliance for Multispecialty Research (AMR) (Pediatric Site)
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Kentucky Pediatric/Adult Research (Pediatric Site)
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Brownsboro Park Pediatrics (Pediatric Site)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Meridian Clinical Research Baton Rouge (Pediatric Site)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Meridian Clinical Research, LLC (Adult Site)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Med Pharmics, LLC (Pediatric & Adult Site)
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Willis-Knighton Physician Network (Adult Site)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Adult Site)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
VA Ann Arbor Healthcare System (Adult Site)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Wayne State University/ Children's Hospital of Michigan (Adult Site)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota (Adult Site)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
MedPharmics, LLC-Biloxi (Pediatric & Adult Site)
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
The Curators of University of Missouri (Adult Site)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Sundance Clinical Research, LLC (Pediatric & Adult Site)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research (Adult & Pediatric Site)
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research Associates, LLC (Pediatric & Adult Site)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
University Of Nebraska Medical Center (Pediatric & Adult Site)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Clinical Research Center of Nevada (Pediatric Site)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Clinical Research Consortium (Adult Site)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Meridian Clinical Research (Pediatric Site)
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Stony Brook Responder Vaccine Program (Adult Site)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Weill Cornell Chelsea CRS (Adult Site)
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Rochester Clinical Research (Pediatric & Adult Site)
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-7064
Country
United States
Facility Name
The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
M3-Emerging Medical Research, LLC (Pediatric & Adult Site)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Carolina Institute for Clinical Research (Adult Site)
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Carolina Institute for Clinical Research (Adult Site)
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Womack Army Medical Center (Adult Site)
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States
Facility Name
M3 Wake Research, Inc (Adult Site)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC (Adult Site)
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site)
City
Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PMG Research of Wilmington, LLC (Adult Site)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Synexus Clinical Research, US, Inc. (Adult Site)
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Sterling Research Group, Ltd. (Adult Site)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Sterling Research Group, Ltd (Pediatric & Adult Site)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Velocity Clinical Research (Pediatric & Adult Site)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research Inc (Pediatric Site)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Medical Research International (Adult Site)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Lynn Health Science Institute (Pediatric & Adult Site)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Velocity Clinical Research (Pediatric & Adult Site)
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc. (Pediatric Site)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
The Miriam Hospital (TMH) (Adult Site)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Omega Medical Research, Providence (Pediatric & Adult Site)
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Synexus Clinical Research US, Inc. (Adult Site)
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical University of South Carolina, SCTR Research Nexus (Adult Site)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Coastal Carolina Research Center (Pediatric Site)
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Spartanburg Medical Research (Pediatric Site)
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
American Indian Clinical Trials Research Network (Pediatric & Adult Site)
City
Eagle Butte
State/Province
South Dakota
ZIP/Postal Code
57625
Country
United States
Facility Name
Accellacare of Bristol (Pediatric & Adult Site)
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
WR Clinsearch, LLC (Pediatric & Adult Site)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Holston Medical Group (Pediatric Site)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Associates (Pediatric Site)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Clinical and Translational Research Center at Meharry Medical College (Adult Site)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Benchmark Research (Pediatric & Adult Site)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Ventavia Research Group, LLC (Pediatric Site)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Benchmark Research (Pediatric & Adult Site)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Ventavia Research Group, LLC (Pediatric Site)
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Baylor College of Medicine (Adult Site)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site)
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Texas Center for Drug Development, Inc (Pediatric & Adult Site)
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
The University Of Texas Medical Branch (Utmb) (Pediatric Site)
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Centex Studies, Inc (Adult Site)
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Research Your Health (Pediatric & Adult site)
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
AES San Antonio (Adult Site)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center San Antonio (Adult Site)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tekton Research, Inc. (Pediatric Site)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
DM Clinical Research (Pediatric & Adult Site)
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Wee Care Pediatrics (Pediatric Site)
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wee Care Pediatrics (Pediatric Site)
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Advanced Clinical Research (Adult Site)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC (Pediatric Site)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Health Research of Hampton Roads, Inc (Pediatric & Adult Site)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
MultiCare Institute for Research & Innovation (Adult Site)
City
Cheney
State/Province
Washington
ZIP/Postal Code
99004
Country
United States
Facility Name
University of Washington VTEU (Adult Site)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
PanAmerican Clinical Research Mexico S.A de C.V (Adult Site)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44609
Country
Mexico
Facility Name
Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site)
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62210
Country
Mexico
Facility Name
PanAmerican Clinical Research Mexico (Adult Site)
City
Juriquilla
State/Province
Queretaro
ZIP/Postal Code
76230
Country
Mexico
Facility Name
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site)
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
CAIMED Investigacion en Salud S.A de C.V (Adult Site)
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Caimed Investigacion en Salud S.A. de C.V. (Adult Site)
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site)
City
Mexico City
Country
Mexico
Facility Name
FAICIC S. DE R.L. DE C.V. (Adult Site)
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site)
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site)
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36172135
Citation
Anez G, Dunkle LM, Gay CL, Kotloff KL, Adelglass JM, Essink B, Campbell JD, Cloney-Clark S, Zhu M, Plested JS, Roychoudhury P, Greninger AL, Patel N, McGarry A, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 - Pediatric Expansion Study Group. Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial. medRxiv. 2022 Sep 21:2022.09.20.22279903. doi: 10.1101/2022.09.20.22279903. Preprint.
Results Reference
derived
PubMed Identifier
34910859
Citation
Dunkle LM, Kotloff KL, Gay CL, Anez G, Adelglass JM, Barrat Hernandez AQ, Harper WL, Duncanson DM, McArthur MA, Florescu DF, McClelland RS, Garcia-Fragoso V, Riesenberg RA, Musante DB, Fried DL, Safirstein BE, McKenzie M, Jeanfreau RJ, Kingsley JK, Henderson JA, Lane DC, Ruiz-Palacios GM, Corey L, Neuzil KM, Coombs RW, Greninger AL, Hutter J, Ake JA, Smith K, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 Study Group. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico. N Engl J Med. 2022 Feb 10;386(6):531-543. doi: 10.1056/NEJMoa2116185. Epub 2021 Dec 15.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

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