Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines | NCT05973006

NCT05973006

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group-A NVX-CoV2601	Experimental	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant	Biological: NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine
Group-B Bivalent NVX CoV2373 + NVX CoV2601	Active Comparator	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant	Biological: Prototype/XBB.1.5 Bivalent Vaccine (5 µg)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine	Biological	Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination	Participants with solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination	Day 7
Participants With Unsolicited AEs Through 28 Days After Vaccination	Participants with unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.	Day 28
Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)	Participants with medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).	Day 180
Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.	The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.	Day 0 and Day 28
Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.

Secondary Outcomes

Measure	Description	Time Frame
Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.	the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points.	Day 0 to Day 180

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adolescents ≥ 12 to < 18 years of age at screening
Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give in-formed consent and assent, as required, 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 post-menopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
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 vaccination.
Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
Have previously received ≥ 2 doses of the Moderna and/or Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines with the last dose having been given ≥ 90 days previously prior to study vaccination.

Exclusion Criteria:

Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
Received influenza vaccination within 14 days prior to study vaccination.
Received any vaccine ≤ 45 days prior to study vaccination, except for rabies, human papilloma virus (HPV), tetanus-diphtheria (Td), tetanus, diphtheria, and pertussis (TDaP/DTap), hepatitis B virus (HBV), and meningococcal vaccines which may be given as medically indicated.
Any known allergies to products contained in the investigational product.
Any history of anaphylaxis to any prior vaccine.
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 study vaccination.

An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
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 therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
Suspected or known history of alcohol abuse or drug addiction within 2 years 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 study 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.
Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing).
Temperature of > 38°C within 24 hours of planned study vaccination (site measured or participant measured).
Blood pressure of ≥ 160/100 mmHg.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Development	Novavax	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alfa Medical Research		Davie	Florida	33024	United States
Westside Center for Clinical Research

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 21, 2023	Jun 3, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
BG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.
BG002	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
	BG00014.5± 1.77 BG00114.5± 1.65 BG00214.5± 1.05

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00099 BG001107 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00043 BG00147 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 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

Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination

Participants with solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination

Posted

Number

participants

Day 7

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Units	Counts
Participants	OG000190 OG001210

Title

Denominators

Categories

Any Solicited AEs

Title	Measurements
	OG000153 OG001166

Local AEs

Title	Measurements
	OG000

Primary

Participants With Unsolicited AEs Through 28 Days After Vaccination

Participants with unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.

Posted

Number

participants

Day 28

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Primary

Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)

Participants with medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).

Posted

Number

participants

Day 180

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Primary

Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.

The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.

Per Protocol Neutralization Assay Subset Population

Posted

Geometric Mean

95% Confidence Interval

geometric mean titer

Day 0 and Day 28

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Primary

Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.

the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28

Posted

Geometric Mean

95% Confidence Interval

geometric mean fold rise

Day 28

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Secondary

Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.

the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points.

Per Protocol Neutralization Assay Subset Population

Posted

Geometric Mean

95% Confidence Interval

geometric mean titer

Day 0 to Day 180

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Secondary

Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.

The neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points.

Per Protocol Neutralization Assay Subset

Posted

Geometric Mean

95% Confidence Interval

geometric mean fold rise

Day 28 to Day 180

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Secondary

IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.

The immunoglobulin G (IgG) antibody levels induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time.at relevant time points.

Per Protocol Anti-S Protein IgG Serology Subset Population

Posted

Geometric Mean

95% Confidence Interval

Elisa Units per mL

Day 0 to Day 180

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Secondary

NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .

The NAb antibody responses induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the ancestral (Wuhan) strain at relevant time points .

Per Protocol Neutralization Assay Subset

Posted

Geometric Mean

95% Confidence Interval

geometric mean titer

Day 0 to 180

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Secondary

Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .

The serum IgG antibody responses induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the ancestral (Wuhan) strain at relevant time points.

Per Protocol Anti-S Protein IgG Serology Subset

Posted

Geometric Mean

95% Confidence Interval

Elisa Units per mL

Day 0 to Day 180

ID	Title	Description
OG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.
OG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group-A NVX-CoV2601	The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine: Coformulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 µg antigen and 100 µg adjuvant per mL. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg antigen with 50 µg Matrix-M adjuvant.	0	190	7	190	10	190
EG001	Group-B Bivalent NVX CoV2373 + NVX CoV2601	The Bivalent NVX CoV2373 + NVX CoV2601 of 5 μg of each antigen with a total of 50 μg of Matrix-M adjuvant Prototype/XBB.1.5 Bivalent Vaccine (5 µg): A site-mixed bivalent vaccine prepared by combining 0.25 mL of NVX-CoV2373 and 0.25 mL NVX-CoV2601. All injections will be administered in a 0.5 mL injection volume at a dose of 5 µg total antigen (2.5 µg prototype antigen + 2.5 µg Omicron XBB.1.5 antigen) with 50 µg Matrix-M adjuvant.	0	210	1	210	4	210

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adjustment disorder with anxiety	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected190 at risk EG0010 events0 affected210 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected190 at risk EG0010 events0 affected210 at risk
Depression	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected190 at risk EG0010 events0 affected210 at risk
Disruptive mood dysregulation disorder	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected190 at risk EG0011 events1 affected210 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected190 at risk EG0010 events0 affected210 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events3 affected190 at risk EG0010 events0 affected210 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG00010 events10 affected190 at risk EG0014 events4 affected210 at risk

First MCP Posted Date

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Units	Counts
Participants	OG000178 OG001194

Units	Counts
Participants	OG000180 OG001196

Units	Counts
Participants	OG000180 OG001196

(1314.33 to 1815.25)

(101227.0 to 126213.4)

(77115.6 to 98382.6)

(55459.2 to 68526.7)

(2453.96 to 3203.51)

(2581.96 to 3313.23)

(2095.11 to 2652.77)