Study to Compare the Immunogenicity and Safety of 3 Lots... | NCT05463068

Status Module

Description Module

Label	Type	Description	Intervention Names
Lot 1	Experimental	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.	Drug: NVX-Cov2373
Lot 2	Experimental	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.	Drug: NVX-Cov2373
Lot 3	Experimental	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.	Drug: NVX-Cov2373

Name	Type	Description	Arm Group Labels	Other Names
NVX-Cov2373	Drug	Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1	Lot 1 Lot 2 Lot 3

Measure	Description	Time Frame
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.	Baseline (Day 1) and Day 29

Measure	Description	Time Frame
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.	Day 29
Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT]

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Name	Affiliation	Role
Clinical Development	Novavax, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Long Beach Clinical Trial Services Inc.		Long Beach	California	90806	United States
Benchmark Research

PubMed Identifier	Type	Citation	Retractions
37652823	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
FG001	Lot 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 20, 2022	Jul 16, 2025

Arm/Group Information

ID	Title	Description
BG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
BG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
BG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00036.2± 8.31 BG00136.5± 8.80 BG00236.6± 8.06 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000175 BG001165 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00050 BG00141 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0003 BG0011 BG002

Previous SARS-CoV-2 infection, n (%)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00017 BG00113 BG002

PCR, n (%)

Count of Participants

Participants

Title

Denominators

Categories

Positive

Title	Measurements
	BG0007 BG0018 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Geometric Mean

95% Confidence Interval

Elisa Units per mL

Baseline (Day 1) and Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Units	Counts
Participants	OG000275 OG001283 OG002290

Title

Denominators

Categories

Baseline (Day 1)

Title	Measurements
	OG00034294.3(29549.6 to 39800.9) OG00136142.6(31430.8 to 41560.8) OG00233233.4(28863.0 to 38265.4)

Secondary

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Secondary

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

Posted

Geometric Mean

95% Confidence Interval

geometric mean titers

Baseline (Day 1) to Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Units

Secondary

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

Posted

Number

95% Confidence Interval

Percentage of participants

Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Units	Counts

Secondary

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

Posted

Geometric Mean

95% Confidence Interval

geometric mean titers

Baseline (Day 1) to Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Secondary

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

Posted

Number

95% Confidence Interval

Percentage of participants

Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Secondary

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)

Posted

Count of Participants

Participants

Day 1 to Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Secondary

Incidence and Severity of MAAEs Through Day 29

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

Posted

Count of Participants

Participants

Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Units	Counts
Participants

Secondary

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

Posted

Count of Participants

Participants

Day 29

ID	Title	Description
OG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
OG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lot 1	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1	298	0	298	7	298
EG001	Lot 2	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1	303	1	303	3	303
EG002	Lot 3	1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. NVX-Cov2373: Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1	304	1	304	4	304

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment		EG0000 events0 affected298 at risk EG0011 events1 affected303 at risk EG0020 events0 affected304 at risk
Escherichia infection	Infections and infestations	MedDRA	Systematic Assessment		EG0000 events0 affected298 at risk EG0010 events0 affected303 at risk EG0021 events1 affected304 at risk

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases