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COVID-19Phase 3NCT05463068

Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

A Phase 3 study testing NVX-Cov2373 in people with COVID-19 and SARS-CoV-2 Infection, run by Novavax at 30 sites in United States.

Completed

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

Official record
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Trial summary

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2 Infection
What is being tested?
NVX-Cov2373
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
911 participants
Where
30 sitesUnited States
Study dates
11 Jul 2022to 1 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • To be included in this study, each individual must satisfy all of the following criteria:
  • Adults 18 to 49 years of age, inclusive, at screening
  • 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 the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit.
  • 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 study vaccination
  • Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
  • Note: For participants who become hospitalized with coronavirus disease 2019 (COVID-19), participation in investigational treatment studies is permitted.
  • Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination.

Who cannot join

  • Participants meeting any of the following criteria will be excluded from the study.
  • History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization.
  • Current participation in research involving receipt of an investigational product (drug/biologic/device).
  • Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product.
  • Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression.
  • Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received 4 days prior to study vaccine, or rabies vaccine which may be received at any time if medically indicated.
Show all 13Show fewer
  • Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
  • Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit.
  • Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
  • 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 (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
  • Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
  • Participants with a history of myocarditis or pericarditis.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Cen/Excel ACMR

    Atlanta, Georgia, 30331

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research

    Austin, Texas, 78747

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70809

  • Velocity Clinical Research

    Boise, Idaho, 83642

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28208

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research

    Cleveland, Ohio, 44122

  • Accel Clinical Research

    DeLand, Florida, 32720

  • Velocity Clinical Research

    East Greenwich, Rhode Island, 02818

  • Meridian Clinical Research

    Endwell, New York, 13760

  • Velocity Clinical Research

    Grants Pass, Oregon, 97527

  • MedPharmics

    Gulfport, Mississippi, 39503

  • Research Centers of America

    Hollywood, Florida, 33024

  • Benchmark Research

    Houston, Texas, 76135

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055

  • Long Beach Clinical Trial Services Inc.

    Long Beach, California, 90806

  • Meridian Clinical Research

    Norfolk, Nebraska, 68701

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Research Your Health

    Plano, Texas, 75093

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Benchmark Research

    Sacramento, California, 95864

  • Tekton Research

    San Antonio, Texas, 78229

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • CRA Headlands

    Stockbridge, Georgia, 30281

  • Tekton Research

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.

Read the detailed description

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.

Being tested
NVX-Cov2373
Keywords
Coronavirus, COVID-19
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

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

  • NVX-Cov2373Drug

    Also called SARS-CoV-2 rS/Matrix-M Adjuvant

    Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Study groups in NCT05463068
Study groupRoleWhat they receive
Lot 1Experimental1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
Receives: Drug: NVX-Cov2373
Lot 2Experimental1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
Receives: Drug: NVX-Cov2373
Lot 3Experimental1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
Receives: Drug: NVX-Cov2373

What is being measured

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

  1. Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs]

    Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.

    Measured: Baseline (Day 1) and Day 29

Secondary outcomes (8)

  1. Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR)

    Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in IgG concentrations to the SARS-CoV-2 spike protein at Day 29.

    Measured: Day 29

  2. Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT]

    Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 1 and Day 29

    Measured: Baseline (Day 1) to Day 29

  3. Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR

    Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 29

    Measured: Day 29

  4. hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT

    hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 1 to Day 29

    Measured: Baseline (Day 1) to Day 29

  5. Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR

    Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 29

    Measured: Day 29

  6. Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)

    Number of participants Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)

    Measured: Day 1 to Day 29

  7. Incidence and Severity of MAAEs Through Day 29

    Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose)

    Measured: Day 29

  8. Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19

    Number of Participants with Unsolicited Treatment-Emergent Adverse Events by COVID-19 throughout the study at Day 29

    Measured: Day 29

Timeline

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

  1. First posted18 Jul 2022
  2. Study start11 Jul 2022
  3. Primary completion17 Aug 2022
  4. Study completion1 Sep 2022

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
911 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463068
Sponsor's protocol ID
2019nCoV-307
Status last verified
Apr 2026
First submitted
14 Jul 2022
Last updated
17 Apr 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Raiser F, Davis M, Adelglass J, Cai MR, Chau G, Cloney-Clark S, Eickhoff M, Kalkeri R, McKnight I, Plested J, Zhu M, Dunkle LM; 2019nCoV-307 study team. Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults. Vaccine. 2023 Sep 22;41(41):5965-5973. doi: 10.1016/j.vaccine.2023.07.056. Epub 2023 Aug 30.

    PubMed 37652823

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NVX-Cov2373 in people with COVID-19 and SARS-CoV-2 Infection, run by Novavax at 30 sites in United States.

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 8 inclusion and 13 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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. 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?

Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs] (time frame: Baseline (Day 1) and Day 29). 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 NCT05463068, which also lists 1 linked publication.

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 17 Apr 2026.

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