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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
911
Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 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.
Time frame: Baseline (Day 1) and Day 29
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.
Time frame: Day 29
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
Time frame: Baseline (Day 1) to Day 29
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
Time frame: Day 29
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
Time frame: Baseline (Day 1) to Day 29
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
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Long Beach Clinical Trial Services Inc.
Long Beach, California, United States
Benchmark Research
Sacramento, California, United States
Accel Clinical Research
DeLand, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Cen/Excel ACMR
Atlanta, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
CRA Headlands
Stockbridge, Georgia, United States
Velocity Clinical Research
Boise, Idaho, United States
...and 20 more locations
Time frame: Day 29
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)
Time frame: Day 1 to Day 29
Incidence and Severity of MAAEs Through Day 29
Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose)
Time frame: Day 29
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
Time frame: Day 29