Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Looking at the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults at Risk for SARS-CoV-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04611802
Recruitment Status : Active, not recruiting
First Posted : November 2, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Novavax

Tracking Information
First Submitted Date  ICMJE October 30, 2020
First Posted Date  ICMJE November 2, 2020
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE December 27, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19) [ Time Frame: Day 28 to Day 750 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • Participants with Symptomatic Moderate or Severe COVID-19 [ Time Frame: Day 28 to Day 750 ]
    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.
  • Participants with Any Symptomatic COVID-19 [ Time Frame: Day 28 to Day 750 ]
    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.
  • Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs) [ Time Frame: Day 0 to Day 105 ]
    Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and Month 3.
  • Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs) [ Time Frame: Day 0 to Day 105 ]
    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and Month 3.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • Serum IgG Antibody Levels Expressed as GMFRs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • Neutralizing Antibody Activity Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.
  • Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.
  • Description of Course, Treatment and Severity of COVID-19 [ Time Frame: Day 28 to Day 750 ]
    Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.
  • Reactogenicity Incidence and Severity [ Time Frame: Day 0 to Day 27 ]
    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).
  • Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49 [ Time Frame: Day 0 to Day 49 ]
    Number of participants with mild, moderate, or severe MAAEs through Day 49.
  • Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49 [ Time Frame: Day 0 to Day 49 ]
    Number of participants with mild, moderate, or severe AEs through Day 49.
  • Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12 [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through Month 12.
  • Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12 [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe SAEs through Month 12.
  • Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12 [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe AESIs through Month 12.
  • Incidence and Severity of SAEs from Month 12 to Month 24 [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe SAEs from Month 12 to Month 24.
  • Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24 [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine from Month 12 to Month 24.
  • Incidence and Severity of AESIs from Month 12 to Month 24 [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe AESIs attributed to study vaccine from Month 12 to Month 24.
  • Deaths Due to Any Cause [ Time Frame: Day 0 to Day 750 ]
    Number of participants who died during the study due to any cause.
  • Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points [ Time Frame: Day 0 to Day 750 ]
    Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or Months 3, 6, 12, 18 and 24 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
  • Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point [ Time Frame: Day 0 to Day 750 ]
    Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
  • IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination [ Time Frame: Day 35 after the 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 from the participants selected for analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
  • Participants with Symptomatic Moderate or Severe COVID-19 [ Time Frame: Day 28 to Day 750 ]
    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.
  • Participants with Any Symptomatic COVID-19 [ Time Frame: Day 28 to Day 750 ]
    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.
  • Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs) [ Time Frame: Day 0 to Day 105 ]
    Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and Month 3.
  • Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs) [ Time Frame: Day 0 to Day 105 ]
    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and Month 3.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • Serum IgG Antibody Levels Expressed as GMFRs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs [ Time Frame: Day 0 to Day 105 ]
    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 Month 3.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    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.
  • Neutralizing Antibody Activity Expressed as GMTs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.
  • Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points [ Time Frame: Day 165 to Day 750 ]
    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.
  • Description of Course, Treatment and Severity of COVID-19 [ Time Frame: Day 28 to Day 750 ]
    Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.
  • Reactogenicity Incidence and Severity [ Time Frame: Day 0 to Day 27 ]
    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).
  • Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49 [ Time Frame: Day 0 to Day 49 ]
    Number of participants with mild, moderate, or severe MAAEs through Day 49.
  • Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49 [ Time Frame: Day 0 to Day 49 ]
    Number of participants with mild, moderate, or severe AEs through Day 49.
  • Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12 [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through Month 12.
  • Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12 [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe SAEs through Month 12.
  • Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12 [ Time Frame: Day 0 to Day 375 ]
    Number of participants with mild, moderate, or severe AESIs through Month 12.
  • Incidence and Severity of SAEs from Month 12 to Month 24 [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe SAEs from Month 12 to Month 24.
  • Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24 [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine from Month 12 to Month 24.
  • Incidence and Severity of AESIs from Month 12 to Month 24 [ Time Frame: Day 360 to Day 750 ]
    Number of participants with mild, moderate, or severe AESIs attributed to study vaccine from Month 12 to Month 24.
  • Deaths Due to Any Cause [ Time Frame: Day 0 to Day 750 ]
    Number of participants who died during the study due to any cause.
  • Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points [ Time Frame: Day 0 to Day 750 ]
    Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or Months 3, 6, 12, 18 and 24 to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.
  • Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point [ Time Frame: Day 0 to Day 750 ]
    Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Looking at the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults at Risk for SARS-CoV-2
Official Title  ICMJE 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
Brief Summary This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections of either ARS-CoV-2 rS with Matrix-M1 adjuvant or placebo in Initial Vaccination Period. Up to 30,000 participants will take part in the study. Following authorization for Emergency Use in the US based on demonstration of statistically significant vaccine efficacy and satisfactory safety in an analysis of the primary endpoint sufficient to support application for EUA, participants will be scheduled for administration of 2 injections of the alternate study material 21 days apart ("blinded crossover"). That is, initial recipients of placebo will receive SARS-CoV-2 rS with Matrix-M1 adjuvant and initial recipients of SARS-CoV-2 rS with Matrix-M1 adjuvant will receive placebo.
Detailed Description

To obtain contact information for a study center near you, please visit:

https://www.novavax.com/PREVENT-19?utm_source=ctgov&utm_medium=link

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV Infection
  • Covid19
Intervention  ICMJE
  • Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
    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.
    Other Name: NVX-CoV2373
  • Other: Placebo (Initial Vaccination Period)
    Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
    Other Name: Sodium chloride 0.9% (BP, sterile)
  • Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
    In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0 or Day 21
    Other Name: NVX-CoV2373
  • Other: Placebo (Crossover Vaccination period)
    In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of placebo (0.5 mL) on Day 0 or Day 21
    Other Name: Sodium chloride 0.9% (BP, sterile)
Study Arms  ICMJE
  • Experimental: SARS-CoV-2 rS/Matrix-M1 Adjuvant
    2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21 in Initial Vaccination Period. One dose of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (co-formulated) on Day 0 or Day 21 in Crossover Vaccination Period.
    Interventions:
    • Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
    • Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
  • Placebo Comparator: Placebo
    2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. One dose of Placebo (Saline) on Day 0 or Day 21 in Crossover Vaccination Period.
    Interventions:
    • Other: Placebo (Initial Vaccination Period)
    • Other: Placebo (Crossover Vaccination period)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2020)
30000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
  • Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
  • Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up.

Exclusion Criteria:

  • 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.
  • Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
  • History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
  • Received influenza vaccination or any other adult vaccine within 4 days prior to or within 7 days after either study vaccination.
  • Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  • Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
  • Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
  • Active cancer (malignancy) on therapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04611802
Other Study ID Numbers  ICMJE 2019nCoV-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novavax
Study Sponsor  ICMJE Novavax
Collaborators  ICMJE Department of Health and Human Services
Investigators  ICMJE
Study Director: Lisa M Dunkle, MD Novavax, Inc.
PRS Account Novavax
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP