ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT04611802
Public ClinicalTrials.gov record NCT04611802. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT04611802
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 33,000 participants
Conditions and interventions
Conditions
Interventions
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) Biological
- Placebo (Initial Vaccination Period) Other
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) Biological
- Placebo (Crossover Vaccination period) Other
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) Biological
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination) Biological
Biological · Other
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 27, 2020 (Actual)
- Primary completion
- Apr 10, 2023 (Actual)
- Completion
- Dec 15, 2023 (Actual)
- Last update posted
- Dec 21, 2023
2020 – 2023
United States locations
- U.S. sites
- 144
- U.S. states
- 37
- U.S. cities
- 113
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| The Pain Center of Arizona (Adult Site) | Phoenix | Arizona | 85018 | — |
| Foothills Research Center-CCT Research (Pediatric Site) | Phoenix | Arizona | 85044 | — |
| Alliance for Multispecialty Research, LLC (Adult Site) | Tempe | Arizona | 85281 | — |
| Lynn Institute of the Ozarks (Adult Site) | Little Rock | Arkansas | 72204 | — |
| Preferred Research Partners, Inc. (Adult Site) | Little Rock | Arkansas | 72211 | — |
| Anaheim Clinical Trials (Adult Site) | Anaheim | California | 92801 | — |
| Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site) | Banning | California | 92220 | — |
| Coast Clinical Research, LLC (Pediatric Site) | Bellflower | California | 90706 | — |
| Velocity Clinical Research (Pediatric & Adult Site) | Chula Vista | California | 91911 | — |
| Premier Health Research Center, Llc (Pediatric Site) | Downey | California | 90240 | — |
| eStudySite - Corporate Offices (Adult Site) | La Mesa | California | 91942 | — |
| Paradigm Clinical Research Centers, Inc (Pediatric Site) | La Mesa | California | 92117 | — |
| WR-PRI, LLC (Adult Site) | Los Alamitos | California | 90720 | — |
| National Research Institute (Pediatric & Adult Site) | Los Angeles | California | 90057 | — |
| Orange County Research Institute (Pediatric Site) | Ontario | California | 91762 | — |
| Empire Clinical Research (Pediatric & Adult Site) | Pomona | California | 91767 | — |
| University of California Davis Health (Pediatric & Adult Site) | Sacramento | California | 95817 | — |
| Benchmark Research (Pediatric & Adult Site) | Sacramento | California | 95864 | — |
| California Research Foundation (Pediatric & Adult Site) | San Diego | California | 92123 | — |
| Synexus Clinical Research US, Inc. (Adult Site) | Vista | California | 92083 | — |
| Dignity Health Medical Foundation - Woodland (Adult Site) | Woodland | California | 95695 | — |
| University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site) | Aurora | Colorado | 80045 | — |
| Lynn Institute of the Rockies (Adult Site) | Colorado Springs | Colorado | 80918 | — |
| 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 | — |
| University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site) | DeLand | Florida | 32720 | — |
| SIMED Health, LLC / SIMED Research (Adult Site) | Gainesville | Florida | 32607 | — |
| M D Clinical (Adult Site) | Hallandale | Florida | 33009 | — |
| Jacksonville Center for Clinical Research (Pediatric & Adult Site) | Jacksonville | Florida | 32216 | — |
| Meridien Research/Accel Research (Pediatric & Adult site) | Lakeland | Florida | 33803 | — |
| 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 | — |
| Clinical Neuroscience Solutions Inc (Pediatric & Adult Site) | Orlando | Florida | 32806 | — |
| Headlands Research Orlando (Adult Site) | Orlando | Florida | 32819 | — |
| Synexus Clinical Research US, Inc (Adult Site) | Pinellas Park | Florida | 33781 | — |
| Asclepes Research Centers (Adult & Pediatric Site) | Spring Hill | Florida | 34609 | — |
| Tampa Heart & Cardiovascular Center (Adult Site) | Tampa | Florida | 33607 | — |
| Office Of John S. Curran MD (Adult Site) | Tampa | Florida | 33612 | — |
| Synexus Clinical Research US, Inc. (Adult Site) | The Villages | Florida | 32162 | — |
| Comprehensive Clinical Trials, Llc (Pediatric & Adult site) | West Palm Beach | Florida | 33409 | — |
| 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 | — |
| Tekton Research, Inc. (Pediatric Site) | Chamblee | Georgia | 30341 | — |
| Columbus Regional Research Institute (Adult Site) | Columbus | Georgia | 31904 | — |
| Clinical Research Atlanta (Adult Site) | Stockbridge | Georgia | 30281 | — |
| Advanced Clinical Research (Pediatric & Adult Site) | Meridian | Idaho | 83642 | — |
| Synexus Clinical Research US, Inc (Adult Site) | Chicago | Illinois | 60602 | — |
| Cedar Crosse Research Center (Adult Site) | Chicago | Illinois | 60607 | — |
| Providea Health Partners LLC (Adult Site) | Evergreen Park | Illinois | 60805 | — |
| Synexus USA (Adult Site) | Evansville | Indiana | 47714 | — |
| Buynak Clinical Research, P.C. (Pediatric & Adult Site) | Valparaiso | Indiana | 46383 | — |
| The University of Iowa Hospitals & Clinics (Adult Site) | Iowa City | Iowa | 52242 | — |
| Meridian Clinical Research (Adult Site) | Sioux City | Iowa | 51106 | — |
| Johnson County Clin-Trials, Inc. (Pediatric & Adult Site) | Lenexa | Kansas | 66219 | — |
| Alliance for Multispecialty Research (AMR) (Pediatric Site) | Newton | Kansas | 67114 | — |
| AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte) | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/Adult Research (Pediatric Site) | Bardstown | Kentucky | 40004 | — |
| Brownsboro Park Pediatrics (Pediatric Site) | Louisville | Kentucky | 40207 | — |
| Meridian Clinical Research Baton Rouge (Pediatric Site) | Baton Rouge | Louisiana | 70809 | — |
| Meridian Clinical Research, LLC (Adult Site) | Baton Rouge | Louisiana | 70809 | — |
| Med Pharmics, LLC (Pediatric & Adult Site) | Metairie | Louisiana | 70006 | — |
| Willis-Knighton Physician Network (Adult Site) | Shreveport | Louisiana | 71101 | — |
| c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site) | Baltimore | Maryland | 21201 | — |
| Beth Israel Deaconess Medical Center (Adult Site) | Boston | Massachusetts | 02215 | — |
| VA Ann Arbor Healthcare System (Adult Site) | Ann Arbor | Michigan | 48105 | — |
| Wayne State University/ Children's Hospital of Michigan (Adult Site) | Detroit | Michigan | 48201 | — |
| University of Minnesota (Adult Site) | Minneapolis | Minnesota | 55455 | — |
| Synexus Clinical Research US, Inc. (Adult Site) | Richfield | Minnesota | 55423 | — |
| MedPharmics, LLC-Biloxi (Pediatric & Adult Site) | Gulfport | Mississippi | 39503 | — |
| The Curators of University of Missouri (Adult Site) | Columbia | Missouri | 65212 | — |
| Sundance Clinical Research, LLC (Pediatric & Adult Site) | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research (Adult & Pediatric Site) | Norfolk | Nebraska | 68701 | — |
| Meridian Clinical Research Associates, LLC (Pediatric & Adult Site) | Omaha | Nebraska | 68134 | — |
| University Of Nebraska Medical Center (Pediatric & Adult Site) | Omaha | Nebraska | 68198 | — |
| Synexus Clinical Research US, Inc. (Adult Site) | Henderson | Nevada | 89052 | — |
| Clinical Research Center of Nevada (Pediatric Site) | Las Vegas | Nevada | 89014 | — |
| Clinical Research Consortium (Adult Site) | Las Vegas | Nevada | 89119 | — |
| Meridian Clinical Research (Pediatric Site) | Binghamton | New York | 13901 | — |
| Stony Brook Responder Vaccine Program (Adult Site) | Commack | New York | 11725 | — |
| Weill Cornell Chelsea CRS (Adult Site) | New York | New York | 10010 | — |
| Rochester Clinical Research (Pediatric & Adult Site) | Rochester | New York | 14609 | — |
| NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site) | Chapel Hill | North Carolina | 27514-7064 | — |
| The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site) | Charlotte | North Carolina | 28207 | — |
| M3-Emerging Medical Research, LLC (Pediatric & Adult Site) | Durham | North Carolina | 27704 | — |
| 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 | — |
| M3 Wake Research, Inc (Adult Site) | Raleigh | North Carolina | 27612 | — |
| PMG Research of Rocky Mount, LLC (Adult Site) | Rocky Mount | North Carolina | 27804 | — |
| Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site) | Salem | North Carolina | 27103 | — |
| PMG Research of Wilmington, LLC (Adult Site) | Wilmington | North Carolina | 28401 | — |
| Synexus Clinical Research, US, Inc. (Adult Site) | Akron | Ohio | 44311 | — |
| 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 | — |
| Aventiv Research Inc (Pediatric Site) | Columbus | Ohio | 43213 | — |
| Medical Research International (Adult Site) | Oklahoma City | Oklahoma | 73109 | — |
| Lynn Health Science Institute (Pediatric & Adult Site) | Oklahoma City | Oklahoma | 73112 | — |
| Velocity Clinical Research (Pediatric & Adult Site) | Medford | Oregon | 97504 | — |
| Preferred Primary Care Physicians, Inc. (Pediatric Site) | Pittsburgh | Pennsylvania | 15236 | — |
| The Miriam Hospital (TMH) (Adult Site) | Providence | Rhode Island | 02904 | — |
| Omega Medical Research, Providence (Pediatric & Adult Site) | Warwick | Rhode Island | 02886 | — |
| Synexus Clinical Research US, Inc. (Adult Site) | Anderson | South Carolina | 29621 | — |
| Medical University of South Carolina, SCTR Research Nexus (Adult Site) | Charleston | South Carolina | 29425 | — |
| Coastal Carolina Research Center (Pediatric Site) | North Charleston | South Carolina | 29405 | — |
| Spartanburg Medical Research (Pediatric Site) | Spartanburg | South Carolina | 29303 | — |
| American Indian Clinical Trials Research Network (Pediatric & Adult Site) | Eagle Butte | South Dakota | 57625 | — |
| Accellacare of Bristol (Pediatric & Adult Site) | Bristol | Tennessee | 37620 | — |
| WR Clinsearch, LLC (Pediatric & Adult Site) | Chattanooga | Tennessee | 37421 | — |
| Holston Medical Group (Pediatric Site) | Kingsport | Tennessee | 37660 | — |
| Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site) | Knoxville | Tennessee | 37938 | — |
| Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site) | Memphis | Tennessee | 38119 | — |
| Clinical Research Associates (Pediatric Site) | Nashville | Tennessee | 37203 | — |
| Clinical and Translational Research Center at Meharry Medical College (Adult Site) | Nashville | Tennessee | 37208 | — |
| Benchmark Research (Pediatric & Adult Site) | Austin | Texas | 78705 | — |
| Ventavia Research Group, LLC (Pediatric Site) | Fort Worth | Texas | 76104 | — |
| Benchmark Research (Pediatric & Adult Site) | Fort Worth | Texas | 76135 | — |
| 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 Texas Medical Branch (Utmb) (Pediatric Site) | League City | Texas | 77573 | — |
| Centex Studies, Inc (Adult Site) | McAllen | Texas | 78504 | — |
| Research Your Health (Pediatric & Adult site) | Plano | Texas | 75093 | — |
| 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 | — |
| DM Clinical Research (Pediatric & Adult Site) | Tomball | Texas | 77375 | — |
| Wee Care Pediatrics (Pediatric Site) | Layton | Utah | 84041 | — |
| Wee Care Pediatrics (Pediatric Site) | Syracuse | Utah | 84075 | — |
| Advanced Clinical Research (Adult Site) | West Jordan | Utah | 84088 | — |
| Pediatric Research of Charlottesville, LLC (Pediatric Site) | Charlottesville | Virginia | 22902 | — |
| Health Research of Hampton Roads, Inc (Pediatric & Adult Site) | Newport News | Virginia | 23606 | — |
| MultiCare Institute for Research & Innovation (Adult Site) | Cheney | Washington | 99004 | — |
| University of Washington VTEU (Adult Site) | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04611802, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2023 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04611802 live on ClinicalTrials.gov.