AzTrials
AzTrials

SARS-CoV InfectionPhase 3NCT04611802

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 study testing SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) and SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) in people with SARS-CoV Infection and Covid19, run by Novavax at 154 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV Infection, Covid19
What is being tested?
SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) and SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33,000 participants
Where
154 sitesin 3 countries
Study dates
27 Dec 2020to 15 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

154 sites in 3 countries.

154 sites in 3 countries

United States144 sites

  • Synexus Clinical Research, US, Inc. (Adult Site)

    Akron, Ohio, 44311

  • Anaheim Clinical Trials (Adult Site)

    Anaheim, California, 92801

  • Synexus Clinical Research US, Inc. (Adult Site)

    Anderson, South Carolina, 29621

  • VA Ann Arbor Healthcare System (Adult Site)

    Ann Arbor, Michigan, 48105

  • Emory University Hospital (Adult Site)

    Atlanta, Georgia, 30303

  • Atlanta - Morehouse School of Medicine (Adult Site)

    Atlanta, Georgia, 30310-1495

  • Synexus Clinical Research US, Inc. (Adult Site)

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research (Adult Site)

    Atlanta, Georgia, 30331

  • University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site)

    Aurora, Colorado, 80045

  • Benchmark Research (Pediatric & Adult Site)

    Austin, Texas, 78705

  • c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site)

    Baltimore, Maryland, 21201

  • Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site)

    Banning, California, 92220

  • Kentucky Pediatric/Adult Research (Pediatric Site)

    Bardstown, Kentucky, 40004

  • Meridian Clinical Research Baton Rouge (Pediatric Site)

    Baton Rouge, Louisiana, 70809

  • Meridian Clinical Research, LLC (Adult Site)

    Baton Rouge, Louisiana, 70809

  • Coast Clinical Research, LLC (Pediatric Site)

    Bellflower, California, 90706

  • Meridian Clinical Research (Pediatric Site)

    Binghamton, New York, 13901

  • Alabama Clinical Therapeutics, Llc (Pediatric Site)

    Birmingham, Alabama, 35205

  • Accel Research Sites (Adult Site)

    Birmingham, Alabama, 35216

  • Central Research Associates, Inc (Pediatric Site)

    Birmingham, Alabama, 35242

  • Beth Israel Deaconess Medical Center (Adult Site)

    Boston, Massachusetts, 02215

  • Accellacare of Bristol (Pediatric & Adult Site)

    Bristol, Tennessee, 37620

  • Tekton Research, Inc. (Pediatric Site)

    Chamblee, Georgia, 30341

  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site)

    Chapel Hill, North Carolina, 27514-7064

  • Medical University of South Carolina, SCTR Research Nexus (Adult Site)

    Charleston, South Carolina, 29425

  • The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site)

    Charlotte, North Carolina, 28207

  • Pediatric Research of Charlottesville, LLC (Pediatric Site)

    Charlottesville, Virginia, 22902

  • WR Clinsearch, LLC (Pediatric & Adult Site)

    Chattanooga, Tennessee, 37421

  • MultiCare Institute for Research & Innovation (Adult Site)

    Cheney, Washington, 99004

  • Synexus Clinical Research US, Inc (Adult Site)

    Chicago, Illinois, 60602

  • Cedar Crosse Research Center (Adult Site)

    Chicago, Illinois, 60607

  • Velocity Clinical Research (Pediatric & Adult Site)

    Chula Vista, California, 91911

  • Sterling Research Group, Ltd. (Adult Site)

    Cincinnati, Ohio, 45219

  • Synexus Clinical Research US, Inc. (Adult Site)

    Cincinnati, Ohio, 45236

  • Sterling Research Group, Ltd (Pediatric & Adult Site)

    Cincinnati, Ohio, 45246

  • Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site)

    Cleveland, Ohio, 44121

  • Velocity Clinical Research (Pediatric & Adult Site)

    Cleveland, Ohio, 44122

  • Lynn Institute of the Rockies (Adult Site)

    Colorado Springs, Colorado, 80918

  • The Curators of University of Missouri (Adult Site)

    Columbia, Missouri, 65212

  • Columbus Regional Research Institute (Adult Site)

    Columbus, Georgia, 31904

  • Aventiv Research Inc (Pediatric Site)

    Columbus, Ohio, 43213

  • Stony Brook Responder Vaccine Program (Adult Site)

    Commack, New York, 11725

  • University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site)

    DeLand, Florida, 32720

  • Wayne State University/ Children's Hospital of Michigan (Adult Site)

    Detroit, Michigan, 48201

  • Premier Health Research Center, Llc (Pediatric Site)

    Downey, California, 90240

  • M3-Emerging Medical Research, LLC (Pediatric & Adult Site)

    Durham, North Carolina, 27704

  • American Indian Clinical Trials Research Network (Pediatric & Adult Site)

    Eagle Butte, South Dakota, 57625

  • Synexus USA (Adult Site)

    Evansville, Indiana, 47714

  • Providea Health Partners LLC (Adult Site)

    Evergreen Park, Illinois, 60805

  • Carolina Institute for Clinical Research (Adult Site)

    Fayetteville, North Carolina, 28303

  • Carolina Institute for Clinical Research (Adult Site)

    Fayetteville, North Carolina, 28304

  • Womack Army Medical Center (Adult Site)

    Fort Bragg, North Carolina, 28310

  • Ventavia Research Group, LLC (Pediatric Site)

    Fort Worth, Texas, 76104

  • Benchmark Research (Pediatric & Adult Site)

    Fort Worth, Texas, 76135

  • SIMED Health, LLC / SIMED Research (Adult Site)

    Gainesville, Florida, 32607

  • MedPharmics, LLC-Biloxi (Pediatric & Adult Site)

    Gulfport, Mississippi, 39503

  • M D Clinical (Adult Site)

    Hallandale, Florida, 33009

  • Synexus Clinical Research US, Inc. (Adult Site)

    Henderson, Nevada, 89052

  • Ventavia Research Group, LLC (Pediatric Site)

    Houston, Texas, 77008

  • Baylor College of Medicine (Adult Site)

    Houston, Texas, 77030

  • DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site)

    Houston, Texas, 77065

  • Texas Center for Drug Development, Inc (Pediatric & Adult Site)

    Houston, Texas, 77081

  • The University of Iowa Hospitals & Clinics (Adult Site)

    Iowa City, Iowa, 52242

  • Jacksonville Center for Clinical Research (Pediatric & Adult Site)

    Jacksonville, Florida, 32216

  • Holston Medical Group (Pediatric Site)

    Kingsport, Tennessee, 37660

  • Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site)

    Knoxville, Tennessee, 37938

  • eStudySite - Corporate Offices (Adult Site)

    La Mesa, California, 91942

  • Paradigm Clinical Research Centers, Inc (Pediatric Site)

    La Mesa, California, 92117

  • Meridien Research/Accel Research (Pediatric & Adult site)

    Lakeland, Florida, 33803

  • Clinical Research Center of Nevada (Pediatric Site)

    Las Vegas, Nevada, 89014

  • Clinical Research Consortium (Adult Site)

    Las Vegas, Nevada, 89119

  • Wee Care Pediatrics (Pediatric Site)

    Layton, Utah, 84041

  • The University Of Texas Medical Branch (Utmb) (Pediatric Site)

    League City, Texas, 77573

  • Johnson County Clin-Trials, Inc. (Pediatric & Adult Site)

    Lenexa, Kansas, 66219

  • Lynn Institute of the Ozarks (Adult Site)

    Little Rock, Arkansas, 72204

  • Preferred Research Partners, Inc. (Adult Site)

    Little Rock, Arkansas, 72211

  • WR-PRI, LLC (Adult Site)

    Los Alamitos, California, 90720

  • National Research Institute (Pediatric & Adult Site)

    Los Angeles, California, 90057

  • Brownsboro Park Pediatrics (Pediatric Site)

    Louisville, Kentucky, 40207

  • Centex Studies, Inc (Adult Site)

    McAllen, Texas, 78504

  • Velocity Clinical Research (Pediatric & Adult Site)

    Medford, Oregon, 97504

  • Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site)

    Memphis, Tennessee, 38119

  • Advanced Clinical Research (Pediatric & Adult Site)

    Meridian, Idaho, 83642

  • Med Pharmics, LLC (Pediatric & Adult Site)

    Metairie, Louisiana, 70006

  • Miami Veterans Affairs Medical Center (Adult Site)

    Miami, Florida, 33125

  • Suncoast Research Associates, LLC (Adult Site)

    Miami, Florida, 33135

  • Acevedo Clinical Research Associates (Pediatric Site)

    Miami, Florida, 33142

  • Suncoast Research Associates, LLC (Adult Site)

    Miami, Florida, 33173

  • University of Minnesota (Adult Site)

    Minneapolis, Minnesota, 55455

  • Clinical Research Associates (Pediatric Site)

    Nashville, Tennessee, 37203

  • Clinical and Translational Research Center at Meharry Medical College (Adult Site)

    Nashville, Tennessee, 37208

  • Weill Cornell Chelsea CRS (Adult Site)

    New York, New York, 10010

  • Health Research of Hampton Roads, Inc (Pediatric & Adult Site)

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research (AMR) (Pediatric Site)

    Newton, Kansas, 67114

  • Meridian Clinical Research (Adult & Pediatric Site)

    Norfolk, Nebraska, 68701

  • Coastal Carolina Research Center (Pediatric Site)

    North Charleston, South Carolina, 29405

  • Medical Research International (Adult Site)

    Oklahoma City, Oklahoma, 73109

  • Lynn Health Science Institute (Pediatric & Adult Site)

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research Associates, LLC (Pediatric & Adult Site)

    Omaha, Nebraska, 68134

  • University Of Nebraska Medical Center (Pediatric & Adult Site)

    Omaha, Nebraska, 68198

  • Orange County Research Institute (Pediatric Site)

    Ontario, California, 91762

  • Clinical Neuroscience Solutions Inc (Pediatric & Adult Site)

    Orlando, Florida, 32806

  • Headlands Research Orlando (Adult Site)

    Orlando, Florida, 32819

  • The Pain Center of Arizona (Adult Site)

    Phoenix, Arizona, 85018

  • Foothills Research Center-CCT Research (Pediatric Site)

    Phoenix, Arizona, 85044

  • Synexus Clinical Research US, Inc (Adult Site)

    Pinellas Park, Florida, 33781

  • Preferred Primary Care Physicians, Inc. (Pediatric Site)

    Pittsburgh, Pennsylvania, 15236

  • Research Your Health (Pediatric & Adult site)

    Plano, Texas, 75093

  • Empire Clinical Research (Pediatric & Adult Site)

    Pomona, California, 91767

  • The Miriam Hospital (TMH) (Adult Site)

    Providence, Rhode Island, 02904

  • M3 Wake Research, Inc (Adult Site)

    Raleigh, North Carolina, 27612

  • Synexus Clinical Research US, Inc. (Adult Site)

    Richfield, Minnesota, 55423

  • Rochester Clinical Research (Pediatric & Adult Site)

    Rochester, New York, 14609

  • PMG Research of Rocky Mount, LLC (Adult Site)

    Rocky Mount, North Carolina, 27804

  • University of California Davis Health (Pediatric & Adult Site)

    Sacramento, California, 95817

  • Benchmark Research (Pediatric & Adult Site)

    Sacramento, California, 95864

  • Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site)

    Salem, North Carolina, 27103

  • AES San Antonio (Adult Site)

    San Antonio, Texas, 78229

  • University of Texas Health Science Center San Antonio (Adult Site)

    San Antonio, Texas, 78229

  • Tekton Research, Inc. (Pediatric Site)

    San Antonio, Texas, 78244

  • California Research Foundation (Pediatric & Adult Site)

    San Diego, California, 92123

  • University of Washington VTEU (Adult Site)

    Seattle, Washington, 98104

  • Willis-Knighton Physician Network (Adult Site)

    Shreveport, Louisiana, 71101

  • Meridian Clinical Research (Adult Site)

    Sioux City, Iowa, 51106

  • Spartanburg Medical Research (Pediatric Site)

    Spartanburg, South Carolina, 29303

  • Asclepes Research Centers (Adult & Pediatric Site)

    Spring Hill, Florida, 34609

  • Sundance Clinical Research, LLC (Pediatric & Adult Site)

    St Louis, Missouri, 63141

  • Clinical Research Atlanta (Adult Site)

    Stockbridge, Georgia, 30281

  • Wee Care Pediatrics (Pediatric Site)

    Syracuse, Utah, 84075

  • Tampa Heart & Cardiovascular Center (Adult Site)

    Tampa, Florida, 33607

  • Office Of John S. Curran MD (Adult Site)

    Tampa, Florida, 33612

  • Alliance for Multispecialty Research, LLC (Adult Site)

    Tempe, Arizona, 85281

  • Synexus Clinical Research US, Inc. (Adult Site)

    The Villages, Florida, 32162

  • DM Clinical Research (Pediatric & Adult Site)

    Tomball, Texas, 77375

  • Buynak Clinical Research, P.C. (Pediatric & Adult Site)

    Valparaiso, Indiana, 46383

  • Synexus Clinical Research US, Inc. (Adult Site)

    Vista, California, 92083

  • Omega Medical Research, Providence (Pediatric & Adult Site)

    Warwick, Rhode Island, 02886

  • Meridian Clinical Research (Pediatric Site)

    Washington D.C., District of Columbia, 20016

  • Howard University Hospital Howard/ University College of Medicine (Adult Site)

    Washington D.C., District of Columbia, 20060

  • Advanced Clinical Research (Adult Site)

    West Jordan, Utah, 84088

  • Comprehensive Clinical Trials, Llc (Pediatric & Adult site)

    West Palm Beach, Florida, 33409

  • AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte)

    Wichita, Kansas, 67207

  • PMG Research of Wilmington, LLC (Adult Site)

    Wilmington, North Carolina, 28401

  • Dignity Health Medical Foundation - Woodland (Adult Site)

    Woodland, California, 95695

Other trials in United States

Mexico8 sites

  • Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site)

    Cuernavaca, Morelos, 62210

  • PanAmerican Clinical Research Mexico S.A de C.V (Adult Site)

    Guadalajara, Jalisco, 44609

  • PanAmerican Clinical Research Mexico (Adult Site)

    Juriquilla, Querétaro, 76230

  • Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site)

    Mérida, Yucatán, 97000

  • CAIMED Investigacion en Salud S.A de C.V (Adult Site)

    Mexico City, 06760

  • Caimed Investigacion en Salud S.A. de C.V. (Adult Site)

    Mexico City, 06760

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site)

    Mexico City

  • FAICIC S. DE R.L. DE C.V. (Adult Site)

    Veracruz, 91900

Other trials in Mexico

Puerto Rico2 sites

  • Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site)

    Ponce, 00716

  • University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site)

    San Juan, 00935

Other trials in Puerto Rico

About this study

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)

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)

Read the 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.

Being tested
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)
Keywords
Coronavirus, Prevent-19, Booster
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called NVX-CoV2373

    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.

  • Placebo (Initial Vaccination Period)Other

    Also called Sodium chloride 0.9% (BP, sterile)

    Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.

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

    Also called NVX-CoV2373

    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

  • Placebo (Crossover Vaccination period)Other

    Also called Sodium chloride 0.9% (BP, sterile)

    In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of placebo (0.5 mL) on Day 0 or Day 21

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

    Also called NVX-CoV2373

    In Booster Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0

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

    Also called NVX-CoV2373

    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

Study groups in NCT04611802
Study groupRoleWhat they receive
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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
Placebo (Initial Vaccination)Placebo comparator2 doses of Placebo (Saline), 1 dose each on Days 0 and 21in Initial Vaccination Period.
Receives: Other: Placebo (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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
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.
Receives: Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)
Placebo (Crossover Vaccination)Placebo comparatorOne dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.
Receives: Other: Placebo (Crossover Vaccination period)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 28 to Day 750

  2. 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).

    Measured: Day 0 to Day 27

  3. 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).

    Measured: Day 0 to Day 49

  4. 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).

    Measured: Day 0 to Day 49

  5. 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.

    Measured: Day 90 to Day 750

  6. 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.

    Measured: Day 90 to Day 750

  7. 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.

    Measured: Day 90 to Day 750

  8. 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.

    Measured: Day 90 to Day 750

  9. 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.

    Measured: Day 90 to Day 750

  10. 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.

    Measured: Day 90 to Day 750

  11. 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.

    Measured: Day 35

  12. Pediatric Expansion: Deaths Due to Any Cause

    Number of participants who died during the study due to any cause.

    Measured: Day 0 to Day 750

Secondary outcomes (29)

  1. 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.

    Measured: Day 28 to Day 750

  2. 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.

    Measured: Day 28 to Day 750

  3. 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.

    Measured: Day 0 to Day 750

  4. 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.

    Measured: Day 0 to Day 750

  5. 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.

    Measured: Day 0 to Day 750

  6. 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.

    Measured: Day 0 to Day 750

  7. 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.

    Measured: Day 0 to Day 750

  8. 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.

    Measured: Day 0 to Day 750

  9. 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.

    Measured: Day 165 to Day 750

  10. 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.

    Measured: Day 165 to Day 750

  11. 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.

    Measured: Day 165 to Day 750

  12. 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.

    Measured: Day 165 to Day 750

  13. 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.

    Measured: Day 165 to Day 750

  14. 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.

    Measured: Day 165 to Day 750

  15. 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.

    Measured: Day 28 to Day 750

  16. 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).

    Measured: Day 0 to Day 27

  17. 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).

    Measured: Day 0 to Day 49

  18. 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).

    Measured: Day 0 to Day 49

  19. 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.

    Measured: Day 90 to Day 750

  20. 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.

    Measured: Day 90 to Day 750

  21. 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.

    Measured: Day 90 to Day 750

  22. 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.

    Measured: Day 90 to Day 750

  23. 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.

    Measured: Day 360 to Day 750

  24. 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.

    Measured: Day 360 to Day 750

  25. 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.

    Measured: Day 0 to Day 750

  26. 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.

    Measured: Day 0 to Day 750

  27. 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.

    Measured: Day 35 after the first crossover vaccination

  28. Adult Main Study : Deaths Due to Any Cause

    Number of participants who died during the study due to any cause.

    Measured: Day 0 to Day 750

  29. 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.

    Measured: Day 28 to Day 750

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2020
  2. Study start27 Dec 2020
  3. Primary completion10 Apr 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611802
Sponsor's protocol ID
2019nCoV-301
Status last verified
Nov 2023
First submitted
30 Oct 2020
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39884302

  • Janes 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.

    PubMed 39225478

  • Turley 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.

    PubMed 37385888

  • Marchese 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.

    PubMed 37127523

  • 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 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.

    PubMed 37099299

  • 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 [Preprint]. 2022 Sep 21:2022.09.20.22279903. doi: 10.1101/2022.09.20.22279903.

    PubMed 36172135

  • 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.

    PubMed 34910859

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) and SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) in people with SARS-CoV Infection and Covid19, run by Novavax at 154 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19) (time frame: Day 28 to Day 750). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04611802, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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