Clinical trial NCT04611802: A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
Official title: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV Infection
Covid19
Keywords: Coronavirus
Prevent-19
Booster
Lead sponsor: Novavax
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2020-11-02
Enrollment: 33000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)

Detailed description: This is a Phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants ≥ 18 years of age (Adult Main Study) and adolescent participants 12 to \<18 years (Pediatric Expansion). Additionally, a Booster Amendment will allow for the evaluation of a booster dose of SARS-CoV-2 rS with Matrix-M1 adjuvant in participants who completed the primary series of active vaccine in the Adult Main Study or Pediatric Expansion, as well as in participants who previously completed the primary series of an authorized/approved COVID-19 vaccine. Additionally, a sub-study conducted at specific sites will allow for the evaluation of a second booster dose of SARS-CoV-2 rS with Matrix-M1 adjuvant in participants who completed the primary series of active vaccine in the Adult Main Study and Pediatric Expansion as well as a booster dose in the Booster Amendment of the study.

Eligibility criteria: Inclusion Criteria:

Adult Participants :

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

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

Pediatric Participants :

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

1. Pediatric participants 12 to \< 18 years of age at screening, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and targeted physical examination \[to include body weight\]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
2. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent, as required, prior to study enrollment and to comply with study procedures.
3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
4. Agree to not participate in another SARS-CoV-2 prevention trial during the study follow-up.
5. For the Booster Amendment only, active participants who received a full dose regimen of active vaccine (SARS-CoV-2 rS with Matrix-M1 adjuvant) or any authorized/approved COVID-19 vaccine are eligible for participation. Such participants must demonstrate receipt by producing valid documentation of vaccination.

Site-Specific Sub Study:

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

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

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

Exclusion Criteria:

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

1. Unstable acute or chronic illness. Criteria for unstable medical conditions include:

   1. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
   2. Currently undergoing workup of undiagnosed illness that could lead to diagnosis of a new condition.

   Note: Well-controlled human immunodeficiency virus \[HIV\] with undetectable HIV RNA \[\< 50 copies/mL\] and CD4 count \> 200 cells/µL for at least 1 year, documented within the last 6 months, is NOT considered an unstable chronic illness. Participant's or parent's/caregiver's verbal report will suffice as documentation.
2. Participation in research involving an investigational product (drug/biologic/device) administered within 45 days prior to first study vaccination.
3. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19. A previous diagnosis of COVID-19 during participation in this trial is not exclusionary for the Booster Amendment.
4. Received any vaccine within 4 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (i.e., 28 days after second vaccination), except for influenza vaccination, which may be received ≥ 4 days prior to or ≥ 7 days after either study vaccination. Rabies vaccine, at any time it is medically indicated, is not exclusionary. Prior receipt of another approved or authorized COVID-19 vaccine prior to booster injection is not exclusionary in the Booster Amendment. Such participants must provide documentation of vaccine and date(s) of administration.
5. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis, including stable diabetes mellitus) are NOT excluded.
6. Chronic administration (defined as \> 14 continuous days) of immunosuppressant or systemic glucocorticoids causing clinically significant immunocompromise, within 90 days prior to first study vaccination and/or third (booster) vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 20 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
7. Received immunoglobulin or blood-derived products, within 90 days prior to first study vaccination and/or third (booster) vaccination.
8. Active cancer (malignancy) on chemotherapy that is judged to cause clinically significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). This criterion is not applicable to participants diagnosed during participation in this trial who accept participation in the Booster Amendment.
9. Any known allergies to products contained in the investigational product.
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant within 3 months following last study vaccination.
11. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.
12. Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
13. Current participation in any other COVID-19 prevention clinical trial.
14. Adult participants who have not received a full dose of any authorized/approved COVID-19 vaccine and are unable to provide valid documentation of vaccination will be excluded from the Booster Amendment.

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

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

Primary outcomes:
measure: Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)
timeFrame: Day 28 to Day 750
measure: Pediatric Expansion: Reactogenicity Incidence and Severity
timeFrame: Day 0 to Day 27
measure: Pediatric Expansion: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49
timeFrame: Day 0 to Day 49
measure: Pediatric Expansion: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49
timeFrame: Day 0 to Day 49
measure: Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points
timeFrame: Day 90 to Day 750
measure: Pediatric Expansion: Incidence and Severity of Serious Adverse Events (SAEs) Through Specified Time Points
timeFrame: Day 90 to Day 750
measure: Pediatric Expansion: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Specified Time Points
timeFrame: Day 90 to Day 750
measure: Pediatric Expansion: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
timeFrame: Day 90 to Day 750
measure: Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
timeFrame: Day 90 to Day 750
measure: Pediatric Expansion: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24
timeFrame: Day 90 to Day 750
measure: Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
timeFrame: Day 35
measure: Pediatric Expansion: Deaths Due to Any Cause
timeFrame: Day 0 to Day 750
Secondary outcomes:
measure: Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19
timeFrame: Day 28 to Day 750
measure: Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19
timeFrame: Day 28 to Day 750
measure: Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: Serum IgG Antibody Levels Expressed as GMFRs
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points
timeFrame: Day 165 to Day 750
measure: Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points
timeFrame: Day 165 to Day 750
measure: Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points
timeFrame: Day 165 to Day 750
measure: Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points
timeFrame: Day 165 to Day 750
measure: Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points
timeFrame: Day 165 to Day 750
measure: Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points
timeFrame: Day 165 to Day 750
measure: Adult Main Study and Pediatric Expansion: Description of Course, Treatment and Severity of COVID-19
timeFrame: Day 28 to Day 750
measure: Adult Main Study: Reactogenicity Incidence and Severity
timeFrame: Day 0 to Day 27
measure: Adult Main Study: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49
timeFrame: Day 0 to Day 49
measure: Adult Main Study: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49
timeFrame: Day 0 to Day 49
measure: Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points
timeFrame: Day 90 to Day 750
measure: Adult Main Study: Incidence and Severity of Serious Adverse Events (SAEs) Attributed to Study Vaccine Through Specified Time Points
timeFrame: Day 90 to Day 750
measure: Adult Main Study: Incidence and Severity of Adverse Events of Special Interest (AESIs) Attributed to Study Vaccine Through Specified Time Points
timeFrame: Day 90 to Day 750
measure: Adult Main Study: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
timeFrame: Day 90 to Day 750
measure: Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24
timeFrame: Day 360 to Day 750
measure: Adult Main Study: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24
timeFrame: Day 360 to Day 750
measure: Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points
timeFrame: Day 0 to Day 750
measure: Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point
timeFrame: Day 0 to Day 750
measure: Adult Main Study: IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination
timeFrame: Day 35 after the first crossover vaccination
measure: Adult Main Study : Deaths Due to Any Cause
timeFrame: Day 0 to Day 750
measure: 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"
timeFrame: Day 28 to Day 750
Other outcomes:
measure: Booster Amendment: Participants with symptomatic mild, moderate or severe COVID-19
timeFrame: Day 0 to Day 7
measure: Booster Amendment: Participants with PCR positive moderate-to-severe COVID-19
timeFrame: Day 0 to Day 7
measure: Booster Amendment: Participants with PCR positive COVID-19 due to a variant not considered "variant of interest/concern"
timeFrame: Day 0 to Day 7
measure: Booster Amendment: Participants with PCR positive COVID-19 due to a 'variant of concern/interest"
timeFrame: Day 0 to Day 7
measure: Booster Amendment: Neutralizing antibody activity expressed as GMT
timeFrame: Day 0 to Day 28
measure: Booster Amendment: Neutralizing antibody activity expressed as GMFR
timeFrame: Day 0 to Day 28
measure: Booster Amendment: Serum IgG antibody levels expressed as GMT
timeFrame: Day 0 to Day 28
measure: Booster Amendment: Serum IgG antibody levels expressed as GMFR
timeFrame: Day 0 to Day 28
measure: Booster Amendment: hACE2 receptor binding inhibition assay expressed as GMT
timeFrame: Day 0 to Day 28
measure: Booster Amendment: hACE2 receptor binding inhibition assay expressed as GMFR
timeFrame: Day 0 to Day 28
measure: Booster Amendment: Incidence and severity of unsolicited AE's
timeFrame: Day 0 to Day 28
measure: Booster Amendment: Incidence and severity of MAAE's, SAE's and AESI's
timeFrame: Day 0 to Day 720
measure: Booster Amendment: Description of course, treatment and severity of COVID-19
timeFrame: Day 0 to Day 7
measure: Booster Amendment: Reactogenicity Incidence and Severity
timeFrame: Day0 to Day 7
measure: Booster Amendment: Deaths Due to Any Cause
timeFrame: Day 0 to Day 720
measure: Site Specific Sub Study: Serum IgG to the SARS-CoV-2 spike protein expressed as GMEU
timeFrame: Day 28
measure: Site Specific Sub Study: Serum IgG antibody expressed as GMFR
timeFrame: Day 28
measure: Site Specific Sub Study: Serum IgG to the SARS-CoV-2 spike protein expressed as SPR
timeFrame: Day 28
measure: Site Specific Sub Study: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs
timeFrame: Day 28
measure: Site Specific Sub Study: hACE2 Receptor Binding Inhibition Assay Expressed as GMFR
timeFrame: Day 28
measure: Site Specific Sub Study: hACE2 Receptor Binding Inhibition Assay Expressed as SPR
timeFrame: Day 28
measure: Site Specific Sub Study: Microneutralization assay (MN) titers to the SARS-CoV-2 wild type virus expressed as GMTs
timeFrame: Day 28
measure: Site Specific Sub Study: Microneutralization assay (MN) titers to the SARS-CoV-2 wild type virus expressed as GMFR
timeFrame: Day 28
measure: Site Specific Sub Study: Microneutralization assay (MN) titers to the SARS-CoV-2 wild type virus expressed as SPR
timeFrame: Day 28
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, Llc (Pediatric Site)
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Sites (Adult Site)
state: Alabama
city: Birmingham
country: United States
facility: Central Research Associates, Inc (Pediatric Site)
state: Alabama
city: Phoenix
country: United States
facility: The Pain Center of Arizona (Adult Site)
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center-CCT Research (Pediatric Site)
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC (Adult Site)
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks (Adult Site)
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc. (Adult Site)
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials (Adult Site)
state: California
city: Banning
country: United States
facility: Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site)
state: California
city: Bellflower
country: United States
facility: Coast Clinical Research, LLC (Pediatric Site)
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research (Pediatric & Adult Site)
state: California
city: Downey
country: United States
facility: Premier Health Research Center, Llc (Pediatric Site)
state: California
city: La Mesa
country: United States
facility: eStudySite - Corporate Offices (Adult Site)
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc (Pediatric Site)
state: California
city: Los Alamitos
country: United States
facility: WR-PRI, LLC (Adult Site)
state: California
city: Los Angeles
country: United States
facility: National Research Institute (Pediatric & Adult Site)
state: California
city: Ontario
country: United States
facility: Orange County Research Institute (Pediatric Site)
state: California
city: Pomona
country: United States
facility: Empire Clinical Research (Pediatric & Adult Site)
state: California
city: Sacramento
country: United States
facility: University of California Davis Health (Pediatric & Adult Site)
state: California
city: Sacramento
country: United States
facility: Benchmark Research (Pediatric & Adult Site)
state: California
city: San Diego
country: United States
facility: California Research Foundation (Pediatric & Adult Site)
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: California
city: Woodland
country: United States
facility: Dignity Health Medical Foundation - Woodland (Adult Site)
state: California
city: Aurora
country: United States
facility: University of Colorado Clinical and Translational Research Centers (Pediatric & Adult Site)
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies (Adult Site)
state: Colorado
city: Washington
country: United States
facility: Meridian Clinical Research (Pediatric Site)
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital Howard/ University College of Medicine (Adult Site)
state: District of Columbia
city: DeLand
country: United States
facility: University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site)
state: Florida
city: Gainesville
country: United States
facility: SIMED Health, LLC / SIMED Research (Adult Site)
state: Florida
city: Hallandale Beach
country: United States
facility: M D Clinical (Adult Site)
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research (Pediatric & Adult Site)
state: Florida
city: Lakeland
country: United States
facility: Meridien Research/Accel Research (Pediatric & Adult site)
state: Florida
city: Miami
country: United States
facility: Miami Veterans Affairs Medical Center (Adult Site)
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC (Adult Site)
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates (Pediatric Site)
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC (Adult Site)
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc (Pediatric & Adult Site)
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando (Adult Site)
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US, Inc (Adult Site)
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Centers (Adult & Pediatric Site)
state: Florida
city: Tampa
country: United States
facility: Tampa Heart & Cardiovascular Center (Adult Site)
state: Florida
city: Tampa
country: United States
facility: Office Of John S. Curran MD (Adult Site)
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, Llc (Pediatric & Adult site)
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital (Adult Site)
state: Georgia
city: Atlanta
country: United States
facility: Atlanta - Morehouse School of Medicine (Adult Site)
state: Georgia
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research (Adult Site)
state: Georgia
city: Chamblee
country: United States
facility: Tekton Research, Inc. (Pediatric Site)
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute (Adult Site)
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta (Adult Site)
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research (Pediatric & Adult Site)
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc (Adult Site)
state: Illinois
city: Chicago
country: United States
facility: Cedar Crosse Research Center (Adult Site)
state: Illinois
city: Evergreen Park
country: United States
facility: Providea Health Partners LLC (Adult Site)
state: Illinois
city: Evansville
country: United States
facility: Synexus USA (Adult Site)
state: Indiana
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C. (Pediatric & Adult Site)
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa Hospitals & Clinics (Adult Site)
state: Iowa
city: Sioux City
country: United States
facility: Meridian Clinical Research (Adult Site)
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc. (Pediatric & Adult Site)
state: Kansas
city: Newton
country: United States
facility: Alliance for Multispecialty Research (AMR) (Pediatric Site)
state: Kansas
city: Wichita
country: United States
facility: AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte)
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research (Pediatric Site)
state: Kentucky
city: Louisville
country: United States
facility: Brownsboro Park Pediatrics (Pediatric Site)
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research Baton Rouge (Pediatric Site)
state: Louisiana
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC (Adult Site)
state: Louisiana
city: Metairie
country: United States
facility: Med Pharmics, LLC (Pediatric & Adult Site)
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network (Adult Site)
state: Louisiana
city: Baltimore
country: United States
facility: c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (Adult Site)
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System (Adult Site)
state: Michigan
city: Detroit
country: United States
facility: Wayne State University/ Children's Hospital of Michigan (Adult Site)
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota (Adult Site)
state: Minnesota
city: Richfield
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: Minnesota
city: Gulfport
country: United States
facility: MedPharmics, LLC-Biloxi (Pediatric & Adult Site)
state: Mississippi
city: Columbia
country: United States
facility: The Curators of University of Missouri (Adult Site)
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC (Pediatric & Adult Site)
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research (Adult & Pediatric Site)
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research Associates, LLC (Pediatric & Adult Site)
state: Nebraska
city: Omaha
country: United States
facility: University Of Nebraska Medical Center (Pediatric & Adult Site)
state: Nebraska
city: Henderson
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada (Pediatric Site)
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Consortium (Adult Site)
state: Nevada
city: Binghamton
country: United States
facility: Meridian Clinical Research (Pediatric Site)
state: New York
city: Commack
country: United States
facility: Stony Brook Responder Vaccine Program (Adult Site)
state: New York
city: New York
country: United States
facility: Weill Cornell Chelsea CRS (Adult Site)
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research (Pediatric & Adult Site)
state: New York
city: Chapel Hill
country: United States
facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill (Pediatric & Adult Site)
state: North Carolina
city: Charlotte
country: United States
facility: The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site)
state: North Carolina
city: Durham
country: United States
facility: M3-Emerging Medical Research, LLC (Pediatric & Adult Site)
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research (Adult Site)
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research (Adult Site)
state: North Carolina
city: Fort Bragg
country: United States
facility: Womack Army Medical Center (Adult Site)
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc (Adult Site)
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC (Adult Site)
state: North Carolina
city: Salem
country: United States
facility: Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site)
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC (Adult Site)
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research, US, Inc. (Adult Site)
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd. (Adult Site)
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd (Pediatric & Adult Site)
state: Ohio
city: Cleveland
country: United States
facility: Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site)
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research (Pediatric & Adult Site)
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc (Pediatric Site)
state: Ohio
city: Oklahoma City
country: United States
facility: Medical Research International (Adult Site)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute (Pediatric & Adult Site)
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research (Pediatric & Adult Site)
state: Oregon
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc. (Pediatric Site)
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital (TMH) (Adult Site)
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research, Providence (Pediatric & Adult Site)
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc. (Adult Site)
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina, SCTR Research Nexus (Adult Site)
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center (Pediatric Site)
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research (Pediatric Site)
state: South Carolina
city: Eagle Butte
country: United States
facility: American Indian Clinical Trials Research Network (Pediatric & Adult Site)
state: South Dakota
city: Bristol
country: United States
facility: Accellacare of Bristol (Pediatric & Adult Site)
state: Tennessee
city: Chattanooga
country: United States
facility: WR Clinsearch, LLC (Pediatric & Adult Site)
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group (Pediatric Site)
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare US Inc., d/b/a Accellacare of Knoxville (Adult Site)
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site)
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates (Pediatric Site)
state: Tennessee
city: Nashville
country: United States
facility: Clinical and Translational Research Center at Meharry Medical College (Adult Site)
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research (Pediatric & Adult Site)
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC (Pediatric Site)
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research (Pediatric & Adult Site)
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group, LLC (Pediatric Site)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine (Adult Site)
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site)
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc (Pediatric & Adult Site)
state: Texas
city: League City
country: United States
facility: The University Of Texas Medical Branch (Utmb) (Pediatric Site)
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc (Adult Site)
state: Texas
city: Plano
country: United States
facility: Research Your Health (Pediatric & Adult site)
state: Texas
city: San Antonio
country: United States
facility: AES San Antonio (Adult Site)
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio (Adult Site)
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc. (Pediatric Site)
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research (Pediatric & Adult Site)
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics (Pediatric Site)
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics (Pediatric Site)
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research (Adult Site)
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC (Pediatric Site)
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc (Pediatric & Adult Site)
state: Virginia
city: Cheney
country: United States
facility: MultiCare Institute for Research & Innovation (Adult Site)
state: Washington
city: Seattle
country: United States
facility: University of Washington VTEU (Adult Site)
state: Washington
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research Mexico S.A de C.V (Adult Site)
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site)
state: Morelos
city: Juriquilla
country: Mexico
facility: PanAmerican Clinical Research Mexico (Adult Site)
state: Queretaro
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site)
state: Yucatan
city: Mexico City
country: Mexico
facility: CAIMED Investigacion en Salud S.A de C.V (Adult Site)
city: Mexico City
country: Mexico
facility: Caimed Investigacion en Salud S.A. de C.V. (Adult Site)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site)
city: Veracruz
country: Mexico
facility: FAICIC S. DE R.L. DE C.V. (Adult Site)
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site)
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site)
Study officials:
affiliation: Novavax, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References:
citation: Anez G, Dunkle LM, Gay CL, Kotloff KL, Adelglass JM, Essink B, Campbell JD, Cloney-Clark S, Zhu M, Plested JS, Roychoudhury P, Greninger AL, Patel N, McGarry A, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 - Pediatric Expansion Study Group. Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial. medRxiv [Preprint]. 2022 Sep 21:2022.09.20.22279903. doi: 10.1101/2022.09.20.22279903.
citation: Dunkle LM, Kotloff KL, Gay CL, Anez G, Adelglass JM, Barrat Hernandez AQ, Harper WL, Duncanson DM, McArthur MA, Florescu DF, McClelland RS, Garcia-Fragoso V, Riesenberg RA, Musante DB, Fried DL, Safirstein BE, McKenzie M, Jeanfreau RJ, Kingsley JK, Henderson JA, Lane DC, Ruiz-Palacios GM, Corey L, Neuzil KM, Coombs RW, Greninger AL, Hutter J, Ake JA, Smith K, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 Study Group. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico. N Engl J Med. 2022 Feb 10;386(6):531-543. doi: 10.1056/NEJMoa2116185. Epub 2021 Dec 15.