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
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)
1 other identifier
interventional
33,000
3 countries
154
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
Typical duration for phase_3
154 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 2, 2020
CompletedStudy Start
First participant enrolled
December 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedDecember 21, 2023
November 1, 2023
2.3 years
October 30, 2020
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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.
Day 28 to Day 750
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).
Day 0 to Day 27
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).
Day 0 to Day 49
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).
Day 0 to Day 49
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.
Day 90 to Day 750
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.
Day 90 to Day 750
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.
Day 90 to Day 750
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.
Day 90 to Day 750
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.
Day 90 to Day 750
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.
Day 90 to Day 750
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.
Day 35
Pediatric Expansion: Deaths Due to Any Cause
Number of participants who died during the study due to any cause.
Day 0 to Day 750
Secondary Outcomes (29)
Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19
Day 28 to Day 750
Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19
Day 28 to Day 750
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)
Day 0 to Day 750
Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)
Day 0 to Day 750
Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs
Day 0 to Day 750
- +24 more secondary outcomes
Other Outcomes (24)
Booster Amendment: Participants with symptomatic mild, moderate or severe COVID-19
Day 0 to Day 7
Booster Amendment: Participants with PCR positive moderate-to-severe COVID-19
Day 0 to Day 7
Booster Amendment: Participants with PCR positive COVID-19 due to a variant not considered "variant of interest/concern"
Day 0 to Day 7
- +21 more other outcomes
Study Arms (6)
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial vaccination)
EXPERIMENTAL2 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.
Placebo (Initial Vaccination)
PLACEBO COMPARATOR2 doses of Placebo (Saline), 1 dose each on Days 0 and 21in Initial Vaccination Period.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination)
EXPERIMENTALOne 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.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
EXPERIMENTALOne dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Booster Vaccination Period.
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster)
EXPERIMENTALOne dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 Second Booster Vaccination Period.
Placebo (Crossover Vaccination)
PLACEBO COMPARATOROne dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.
Interventions
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.
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
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
In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of placebo (0.5 mL) on Day 0 or Day 21
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
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
Eligibility Criteria
You may qualify if:
- 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.
- +10 more criteria
You may not qualify if:
- 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.
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
- Department of Health and Human Servicescollaborator
Study Sites (154)
Alabama Clinical Therapeutics, Llc (Pediatric Site)
Birmingham, Alabama, 35205, United States
Accel Research Sites (Adult Site)
Birmingham, Alabama, 35216, United States
Central Research Associates, Inc (Pediatric Site)
Birmingham, Alabama, 35242, United States
The Pain Center of Arizona (Adult Site)
Phoenix, Arizona, 85018, United States
Foothills Research Center-CCT Research (Pediatric Site)
Phoenix, Arizona, 85044, United States
Alliance for Multispecialty Research, LLC (Adult Site)
Tempe, Arizona, 85281, United States
Lynn Institute of the Ozarks (Adult Site)
Little Rock, Arkansas, 72204, United States
Preferred Research Partners, Inc. (Adult Site)
Little Rock, Arkansas, 72211, United States
Anaheim Clinical Trials (Adult Site)
Anaheim, California, 92801, United States
Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site)
Banning, California, 92220, United States
Coast Clinical Research, LLC (Pediatric Site)
Bellflower, California, 90706, United States
Velocity Clinical Research (Pediatric & Adult Site)
Chula Vista, California, 91911, United States
Premier Health Research Center, Llc (Pediatric Site)
Downey, California, 90240, United States
eStudySite - Corporate Offices (Adult Site)
La Mesa, California, 91942, United States
Paradigm Clinical Research Centers, Inc (Pediatric Site)
La Mesa, California, 92117, United States
WR-PRI, LLC (Adult Site)
Los Alamitos, California, 90720, United States
National Research Institute (Pediatric & Adult Site)
Los Angeles, California, 90057, United States
Orange County Research Institute (Pediatric Site)
Ontario, California, 91762, United States
Empire Clinical Research (Pediatric & Adult Site)
Pomona, California, 91767, United States
University of California Davis Health (Pediatric & Adult Site)
Sacramento, California, 95817, United States
Benchmark Research (Pediatric & Adult Site)
Sacramento, California, 95864, United States
California Research Foundation (Pediatric & Adult Site)
San Diego, California, 92123, United States
Synexus Clinical Research US, Inc. (Adult Site)
Vista, California, 92083, United States
Dignity Health Medical Foundation - Woodland (Adult Site)
Woodland, California, 95695, United States
University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site)
Aurora, Colorado, 80045, United States
Lynn Institute of the Rockies (Adult Site)
Colorado Springs, Colorado, 80918, United States
Meridian Clinical Research (Pediatric Site)
Washington D.C., District of Columbia, 20016, United States
Howard University Hospital Howard/ University College of Medicine (Adult Site)
Washington D.C., District of Columbia, 20060, United States
University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site)
DeLand, Florida, 32720, United States
SIMED Health, LLC / SIMED Research (Adult Site)
Gainesville, Florida, 32607, United States
M D Clinical (Adult Site)
Hallandale, Florida, 33009, United States
Jacksonville Center for Clinical Research (Pediatric & Adult Site)
Jacksonville, Florida, 32216, United States
Meridien Research/Accel Research (Pediatric & Adult site)
Lakeland, Florida, 33803, United States
Miami Veterans Affairs Medical Center (Adult Site)
Miami, Florida, 33125, United States
Suncoast Research Associates, LLC (Adult Site)
Miami, Florida, 33135, United States
Acevedo Clinical Research Associates (Pediatric Site)
Miami, Florida, 33142, United States
Suncoast Research Associates, LLC (Adult Site)
Miami, Florida, 33173, United States
Clinical Neuroscience Solutions Inc (Pediatric & Adult Site)
Orlando, Florida, 32806, United States
Headlands Research Orlando (Adult Site)
Orlando, Florida, 32819, United States
Synexus Clinical Research US, Inc (Adult Site)
Pinellas Park, Florida, 33781, United States
Asclepes Research Centers (Adult & Pediatric Site)
Spring Hill, Florida, 34609, United States
Tampa Heart & Cardiovascular Center (Adult Site)
Tampa, Florida, 33607, United States
Office Of John S. Curran MD (Adult Site)
Tampa, Florida, 33612, United States
Synexus Clinical Research US, Inc. (Adult Site)
The Villages, Florida, 32162, United States
Comprehensive Clinical Trials, Llc (Pediatric & Adult site)
West Palm Beach, Florida, 33409, United States
Emory University Hospital (Adult Site)
Atlanta, Georgia, 30303, United States
Atlanta - Morehouse School of Medicine (Adult Site)
Atlanta, Georgia, 30310-1495, United States
Synexus Clinical Research US, Inc. (Adult Site)
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research (Adult Site)
Atlanta, Georgia, 30331, United States
Tekton Research, Inc. (Pediatric Site)
Chamblee, Georgia, 30341, United States
Columbus Regional Research Institute (Adult Site)
Columbus, Georgia, 31904, United States
Clinical Research Atlanta (Adult Site)
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research (Pediatric & Adult Site)
Meridian, Idaho, 83642, United States
Synexus Clinical Research US, Inc (Adult Site)
Chicago, Illinois, 60602, United States
Cedar Crosse Research Center (Adult Site)
Chicago, Illinois, 60607, United States
Providea Health Partners LLC (Adult Site)
Evergreen Park, Illinois, 60805, United States
Synexus USA (Adult Site)
Evansville, Indiana, 47714, United States
Buynak Clinical Research, P.C. (Pediatric & Adult Site)
Valparaiso, Indiana, 46383, United States
The University of Iowa Hospitals & Clinics (Adult Site)
Iowa City, Iowa, 52242, United States
Meridian Clinical Research (Adult Site)
Sioux City, Iowa, 51106, United States
Johnson County Clin-Trials, Inc. (Pediatric & Adult Site)
Lenexa, Kansas, 66219, United States
Alliance for Multispecialty Research (AMR) (Pediatric Site)
Newton, Kansas, 67114, United States
AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte)
Wichita, Kansas, 67207, United States
Kentucky Pediatric/Adult Research (Pediatric Site)
Bardstown, Kentucky, 40004, United States
Brownsboro Park Pediatrics (Pediatric Site)
Louisville, Kentucky, 40207, United States
Meridian Clinical Research Baton Rouge (Pediatric Site)
Baton Rouge, Louisiana, 70809, United States
Meridian Clinical Research, LLC (Adult Site)
Baton Rouge, Louisiana, 70809, United States
Med Pharmics, LLC (Pediatric & Adult Site)
Metairie, Louisiana, 70006, United States
Willis-Knighton Physician Network (Adult Site)
Shreveport, Louisiana, 71101, United States
c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site)
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess Medical Center (Adult Site)
Boston, Massachusetts, 02215, United States
VA Ann Arbor Healthcare System (Adult Site)
Ann Arbor, Michigan, 48105, United States
Wayne State University/ Children's Hospital of Michigan (Adult Site)
Detroit, Michigan, 48201, United States
University of Minnesota (Adult Site)
Minneapolis, Minnesota, 55455, United States
Synexus Clinical Research US, Inc. (Adult Site)
Richfield, Minnesota, 55423, United States
MedPharmics, LLC-Biloxi (Pediatric & Adult Site)
Gulfport, Mississippi, 39503, United States
The Curators of University of Missouri (Adult Site)
Columbia, Missouri, 65212, United States
Sundance Clinical Research, LLC (Pediatric & Adult Site)
St Louis, Missouri, 63141, United States
Meridian Clinical Research (Adult & Pediatric Site)
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research Associates, LLC (Pediatric & Adult Site)
Omaha, Nebraska, 68134, United States
University Of Nebraska Medical Center (Pediatric & Adult Site)
Omaha, Nebraska, 68198, United States
Synexus Clinical Research US, Inc. (Adult Site)
Henderson, Nevada, 89052, United States
Clinical Research Center of Nevada (Pediatric Site)
Las Vegas, Nevada, 89014, United States
Clinical Research Consortium (Adult Site)
Las Vegas, Nevada, 89119, United States
Meridian Clinical Research (Pediatric Site)
Binghamton, New York, 13901, United States
Stony Brook Responder Vaccine Program (Adult Site)
Commack, New York, 11725, United States
Weill Cornell Chelsea CRS (Adult Site)
New York, New York, 10010, United States
Rochester Clinical Research (Pediatric & Adult Site)
Rochester, New York, 14609, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site)
Chapel Hill, North Carolina, 27514-7064, United States
The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site)
Charlotte, North Carolina, 28207, United States
M3-Emerging Medical Research, LLC (Pediatric & Adult Site)
Durham, North Carolina, 27704, United States
Carolina Institute for Clinical Research (Adult Site)
Fayetteville, North Carolina, 28303, United States
Carolina Institute for Clinical Research (Adult Site)
Fayetteville, North Carolina, 28304, United States
Womack Army Medical Center (Adult Site)
Fort Bragg, North Carolina, 28310, United States
M3 Wake Research, Inc (Adult Site)
Raleigh, North Carolina, 27612, United States
PMG Research of Rocky Mount, LLC (Adult Site)
Rocky Mount, North Carolina, 27804, United States
Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site)
Salem, North Carolina, 27103, United States
PMG Research of Wilmington, LLC (Adult Site)
Wilmington, North Carolina, 28401, United States
Synexus Clinical Research, US, Inc. (Adult Site)
Akron, Ohio, 44311, United States
Sterling Research Group, Ltd. (Adult Site)
Cincinnati, Ohio, 45219, United States
Synexus Clinical Research US, Inc. (Adult Site)
Cincinnati, Ohio, 45236, United States
Sterling Research Group, Ltd (Pediatric & Adult Site)
Cincinnati, Ohio, 45246, United States
Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site)
Cleveland, Ohio, 44121, United States
Velocity Clinical Research (Pediatric & Adult Site)
Cleveland, Ohio, 44122, United States
Aventiv Research Inc (Pediatric Site)
Columbus, Ohio, 43213, United States
Medical Research International (Adult Site)
Oklahoma City, Oklahoma, 73109, United States
Lynn Health Science Institute (Pediatric & Adult Site)
Oklahoma City, Oklahoma, 73112, United States
Velocity Clinical Research (Pediatric & Adult Site)
Medford, Oregon, 97504, United States
Preferred Primary Care Physicians, Inc. (Pediatric Site)
Pittsburgh, Pennsylvania, 15236, United States
The Miriam Hospital (TMH) (Adult Site)
Providence, Rhode Island, 02904, United States
Omega Medical Research, Providence (Pediatric & Adult Site)
Warwick, Rhode Island, 02886, United States
Synexus Clinical Research US, Inc. (Adult Site)
Anderson, South Carolina, 29621, United States
Medical University of South Carolina, SCTR Research Nexus (Adult Site)
Charleston, South Carolina, 29425, United States
Coastal Carolina Research Center (Pediatric Site)
North Charleston, South Carolina, 29405, United States
Spartanburg Medical Research (Pediatric Site)
Spartanburg, South Carolina, 29303, United States
American Indian Clinical Trials Research Network (Pediatric & Adult Site)
Eagle Butte, South Dakota, 57625, United States
Accellacare of Bristol (Pediatric & Adult Site)
Bristol, Tennessee, 37620, United States
WR Clinsearch, LLC (Pediatric & Adult Site)
Chattanooga, Tennessee, 37421, United States
Holston Medical Group (Pediatric Site)
Kingsport, Tennessee, 37660, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site)
Knoxville, Tennessee, 37938, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site)
Memphis, Tennessee, 38119, United States
Clinical Research Associates (Pediatric Site)
Nashville, Tennessee, 37203, United States
Clinical and Translational Research Center at Meharry Medical College (Adult Site)
Nashville, Tennessee, 37208, United States
Benchmark Research (Pediatric & Adult Site)
Austin, Texas, 78705, United States
Ventavia Research Group, LLC (Pediatric Site)
Fort Worth, Texas, 76104, United States
Benchmark Research (Pediatric & Adult Site)
Fort Worth, Texas, 76135, United States
Ventavia Research Group, LLC (Pediatric Site)
Houston, Texas, 77008, United States
Baylor College of Medicine (Adult Site)
Houston, Texas, 77030, United States
DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site)
Houston, Texas, 77065, United States
Texas Center for Drug Development, Inc (Pediatric & Adult Site)
Houston, Texas, 77081, United States
The University Of Texas Medical Branch (Utmb) (Pediatric Site)
League City, Texas, 77573, United States
Centex Studies, Inc (Adult Site)
McAllen, Texas, 78504, United States
Research Your Health (Pediatric & Adult site)
Plano, Texas, 75093, United States
AES San Antonio (Adult Site)
San Antonio, Texas, 78229, United States
University of Texas Health Science Center San Antonio (Adult Site)
San Antonio, Texas, 78229, United States
Tekton Research, Inc. (Pediatric Site)
San Antonio, Texas, 78244, United States
DM Clinical Research (Pediatric & Adult Site)
Tomball, Texas, 77375, United States
Wee Care Pediatrics (Pediatric Site)
Layton, Utah, 84041, United States
Wee Care Pediatrics (Pediatric Site)
Syracuse, Utah, 84075, United States
Advanced Clinical Research (Adult Site)
West Jordan, Utah, 84088, United States
Pediatric Research of Charlottesville, LLC (Pediatric Site)
Charlottesville, Virginia, 22902, United States
Health Research of Hampton Roads, Inc (Pediatric & Adult Site)
Newport News, Virginia, 23606, United States
MultiCare Institute for Research & Innovation (Adult Site)
Cheney, Washington, 99004, United States
University of Washington VTEU (Adult Site)
Seattle, Washington, 98104, United States
PanAmerican Clinical Research Mexico S.A de C.V (Adult Site)
Guadalajara, Jalisco, 44609, Mexico
Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site)
Cuernavaca, Morelos, 62210, Mexico
PanAmerican Clinical Research Mexico (Adult Site)
Juriquilla, Querétaro, 76230, Mexico
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site)
Mérida, Yucatán, 97000, Mexico
CAIMED Investigacion en Salud S.A de C.V (Adult Site)
Mexico City, 06760, Mexico
Caimed Investigacion en Salud S.A. de C.V. (Adult Site)
Mexico City, 06760, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site)
Mexico City, Mexico
FAICIC S. DE R.L. DE C.V. (Adult Site)
Veracruz, 91900, Mexico
Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site)
Ponce, 00716, Puerto Rico
University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site)
San Juan, 00935, Puerto Rico
Related Publications (7)
Deming ME, Brown ER, McArthur MA, Schrag SJ, Arvay M, Humphrys M, Ravel J, Adelglass J, Essink B, Musante DB, Maguire R, Gorman R, Formentini E, Mason R, Robb ML, Neuzil KM, Rapaka RR, Wolff P, Kotloff KL; SNIFF study team. Vaccine efficacy of NVX-CoV2373 against SARS-CoV-2 infection in adolescents in the USA: an ancillary study to a phase 3, observer-blinded, randomised, placebo-controlled trial. Lancet Microbe. 2025 Apr;6(4):100984. doi: 10.1016/j.lanmic.2024.100984. Epub 2025 Jan 27.
PMID: 39884302DERIVEDJanes H, Fisher LH, Kee JJ, Parameswaran L, Goepfert PA, Falsey AR, Ludwig J, Magaret CA, Gilbert PB, Kublin JG, Rouphael N, Sobieszczyk ME, El Sahly HM, Baden LR, Grinsztejn B, Walsh SR, Gray GE, Kotloff KL, Gay CL, Greninger AL, Tapia MD, Hammershaimb EA, Priddy FH, Green JA, Struyf F, Dunkle L, Neuzil KM, Corey L, Huang Y. Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials. J Infect Dis. 2024 Dec 16;230(6):1384-1389. doi: 10.1093/infdis/jiae400.
PMID: 39225478DERIVEDTurley CB, Tables L, Fuller T, Sanders LJ, Scott H, Moodley A, Woodward Davis A, Leav B, Miller J, Schoemaker K, Vandebosch A, Sadoff J, Woo W, Cho I, Dunkle LM, Li S, van der Laan L, Gilbert PB, Follmann D, Jaynes H, Kublin JG, Baden LR, Goepfert P, Kotloff K, Gay CL, Falsey AR, El Sahly HM, Sobieszczyk ME, Huang Y, Neuzil KM, Corey L, Grinsztejn B, Gray G, Rouphael N, Luedtke A; COVID-19 Prevention Network CoVPN. Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials. Vaccine. 2023 Jul 25;41(33):4899-4906. doi: 10.1016/j.vaccine.2023.06.066. Epub 2023 Jun 23.
PMID: 37385888DERIVEDMarchese AM, Zhou X, Kinol J, Underwood E, Woo W, McGarry A, Beyhaghi H, Anez G, Toback S, Dunkle LM. NVX-CoV2373 vaccine efficacy against hospitalization: A post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial. Vaccine. 2023 May 22;41(22):3461-3466. doi: 10.1016/j.vaccine.2023.04.054. Epub 2023 Apr 29.
PMID: 37127523DERIVEDAnez 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 the NVX-CoV2373 COVID-19 Vaccine in Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239135. doi: 10.1001/jamanetworkopen.2023.9135.
PMID: 37099299DERIVEDAnez 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 [Preprint]. 2022 Sep 21:2022.09.20.22279903. doi: 10.1101/2022.09.20.22279903.
PMID: 36172135DERIVEDDunkle 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.
PMID: 34910859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development
Novavax, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
November 2, 2020
Study Start
December 27, 2020
Primary Completion
April 10, 2023
Study Completion
December 15, 2023
Last Updated
December 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share