Trial Outcomes & Findings for Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines (NCT NCT05973006)
NCT ID: NCT05973006
Last Updated: 2025-07-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
Day 7
Results posted on
2025-07-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
190
|
210
|
|
Overall Study
COMPLETED
|
187
|
201
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
Early termination
|
3
|
9
|
Baseline Characteristics
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
Baseline characteristics by cohort
| Measure |
Group-A NVX-CoV2601
n=190 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=210 Participants
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.
|
Total
n=400 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
14.5 years
STANDARD_DEVIATION 1.77 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 1.65 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 1.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Participants 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
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=190 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=210 Participants
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.
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|---|---|---|
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Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination
Local AEs
|
136 participants
|
140 participants
|
|
Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination
Systemic AEs
|
116 participants
|
120 participants
|
|
Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination
Any Solicited AEs
|
153 participants
|
166 participants
|
PRIMARY outcome
Timeframe: Day 28Participants 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.
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=190 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=210 Participants
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.
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|---|---|---|
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Participants With Unsolicited AEs Through 28 Days After Vaccination
Any unsolicited TEAE through 28 days after study vaccination
|
25 participants
|
25 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Infections and infestations
|
15 participants
|
13 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
General disorders and administration site conditions
|
3 participants
|
3 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Respiratory, thoracic and mediastinal disorders
|
2 participants
|
3 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Nervous system disorders
|
0 participants
|
1 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Metabolism and nutrition disorders
|
0 participants
|
1 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Psychiatric disorders
|
4 participants
|
2 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Gastrointestinal disorders
|
3 participants
|
1 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Skin and subcutaneous tissue disorders
|
2 participants
|
1 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Injury, poisoning and procedural complications
|
2 participants
|
0 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Blood and lymphatic system disorders
|
1 participants
|
1 participants
|
|
Participants With Unsolicited AEs Through 28 Days After Vaccination
Musculoskeletal and connective tissue disorders
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 180Participants 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).
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=190 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=210 Participants
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.
|
|---|---|---|
|
Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)
Any TEAEs
|
25 participants
|
25 participants
|
|
Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)
Any MAAEs
|
16 participants
|
12 participants
|
|
Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)
Any Serious TEAEs
|
4 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28Population: Per Protocol Neutralization Assay Subset Population
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.
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=178 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=194 Participants
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.
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|---|---|---|
|
Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Day 0
|
208.40 geometric mean titer
Interval 166.2 to 261.32
|
184.81 geometric mean titer
Interval 148.86 to 229.45
|
|
Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Day 28
|
2533.08 geometric mean titer
Interval 2107.17 to 3045.07
|
1544.61 geometric mean titer
Interval 1314.33 to 1815.25
|
PRIMARY outcome
Timeframe: Day 28the 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
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=178 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=194 Participants
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.
|
|---|---|---|
|
Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
|
12.2 geometric mean fold rise
Interval 9.5 to 15.5
|
8.4 geometric mean fold rise
Interval 6.8 to 10.3
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: Per Protocol Neutralization Assay Subset Population
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.
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=180 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=196 Participants
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.
|
|---|---|---|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Day 0
|
204.98 geometric mean titer
Interval 163.68 to 256.69
|
183.37 geometric mean titer
Interval 147.82 to 227.47
|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Day 28
|
2533.08 geometric mean titer
Interval 2107.17 to 3045.07
|
1544.61 geometric mean titer
Interval 1314.33 to 1815.25
|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Day 90
|
1816.50 geometric mean titer
Interval 1505.62 to 2191.56
|
1171.90 geometric mean titer
Interval 997.69 to 1376.52
|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
Day 180
|
1369.61 geometric mean titer
Interval 1128.29 to 1662.53
|
866.10 geometric mean titer
Interval 733.49 to 1022.67
|
SECONDARY outcome
Timeframe: Day 28 to Day 180Population: Per Protocol Neutralization Assay Subset
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.
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=180 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=196 Participants
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.
|
|---|---|---|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
Day 90
|
8.6 geometric mean fold rise
Interval 6.7 to 11.1
|
6.2 geometric mean fold rise
Interval 5.0 to 7.7
|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
Day 180
|
6.0 geometric mean fold rise
Interval 4.7 to 7.8
|
4.7 geometric mean fold rise
Interval 3.7 to 5.9
|
|
Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
Day 28
|
12.2 geometric mean fold rise
Interval 9.5 to 15.5
|
8.4 geometric mean fold rise
Interval 6.8 to 10.3
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: Per Protocol Anti-S Protein IgG Serology Subset Population
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.
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=180 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=196 Participants
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.
|
|---|---|---|
|
IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.
Day 0
|
38825.1 Elisa Units per mL
Interval 33160.1 to 45457.9
|
32881.9 Elisa Units per mL
Interval 28434.7 to 38024.7
|
|
IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.
Day 28
|
150232.9 Elisa Units per mL
Interval 132853.6 to 169885.6
|
113031.9 Elisa Units per mL
Interval 101227.0 to 126213.4
|
|
IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.
Day 90
|
110091.1 Elisa Units per mL
Interval 96294.7 to 125864.3
|
87102.4 Elisa Units per mL
Interval 77115.6 to 98382.6
|
|
IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.
Day 180
|
77149.8 Elisa Units per mL
Interval 68110.5 to 87388.8
|
61647.7 Elisa Units per mL
Interval 55459.2 to 68526.7
|
SECONDARY outcome
Timeframe: Day 0 to 180Population: Per Protocol Neutralization Assay Subset
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 .
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=180 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=196 Participants
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.
|
|---|---|---|
|
NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 0
|
1321.00 geometric mean titer
Interval 1123.04 to 1553.87
|
1197.59 geometric mean titer
Interval 1029.9 to 1392.58
|
|
NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 28
|
3510.84 geometric mean titer
Interval 3099.99 to 3976.14
|
2803.80 geometric mean titer
Interval 2453.96 to 3203.51
|
|
NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 90
|
3381.08 geometric mean titer
Interval 2991.33 to 3821.62
|
2924.82 geometric mean titer
Interval 2581.96 to 3313.23
|
|
NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 180
|
2663.87 geometric mean titer
Interval 2334.49 to 3039.72
|
2357.51 geometric mean titer
Interval 2095.11 to 2652.77
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: Per Protocol Anti-S Protein IgG Serology Subset
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.
Outcome measures
| Measure |
Group-A NVX-CoV2601
n=180 Participants
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=196 Participants
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.
|
|---|---|---|
|
Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 180
|
104890.2 Elisa Units per mL
Interval 93135.9 to 118128.0
|
94026.0 Elisa Units per mL
Interval 84606.1 to 104494.8
|
|
Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 0
|
71388.4 Elisa Units per mL
Interval 62262.8 to 81851.6
|
61296.9 Elisa Units per mL
Interval 53962.1 to 69628.5
|
|
Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 28
|
181736.6 Elisa Units per mL
Interval 162092.7 to 203761.1
|
157077.8 Elisa Units per mL
Interval 141109.2 to 174853.4
|
|
Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .
Day 90
|
142032.4 Elisa Units per mL
Interval 124824.9 to 161611.9
|
130155.1 Elisa Units per mL
Interval 116798.0 to 145039.8
|
Adverse Events
Group-A NVX-CoV2601
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Group-B Bivalent NVX CoV2373 + NVX CoV2601
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group-A NVX-CoV2601
n=190 participants at risk
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=210 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.53%
1/190 • Number of events 1 • 180 Days
|
0.00%
0/210 • 180 Days
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.53%
1/190 • Number of events 1 • 180 Days
|
0.00%
0/210 • 180 Days
|
|
Psychiatric disorders
Depression
|
0.53%
1/190 • Number of events 1 • 180 Days
|
0.00%
0/210 • 180 Days
|
|
Psychiatric disorders
Disruptive mood dysregulation disorder
|
0.00%
0/190 • 180 Days
|
0.48%
1/210 • Number of events 1 • 180 Days
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.53%
1/190 • Number of events 1 • 180 Days
|
0.00%
0/210 • 180 Days
|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
3/190 • Number of events 3 • 180 Days
|
0.00%
0/210 • 180 Days
|
Other adverse events
| Measure |
Group-A NVX-CoV2601
n=190 participants at risk
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.
|
Group-B Bivalent NVX CoV2373 + NVX CoV2601
n=210 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
10/190 • Number of events 10 • 180 Days
|
1.9%
4/210 • Number of events 4 • 180 Days
|
Additional Information
Novavax Customer Service Center
Novavax Inc.
Phone: 1-844-Novavax (668-2829)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER