Trial Outcomes & Findings for Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults (NCT NCT05463068)
NCT ID: NCT05463068
Last Updated: 2026-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
911 participants
Primary outcome timeframe
Baseline (Day 1) and Day 29
Results posted on
2026-04-17
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
298
|
303
|
304
|
|
Overall Study
COMPLETED
|
283
|
289
|
293
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
11
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
2
|
|
Overall Study
Sponsor decision
|
6
|
9
|
3
|
|
Overall Study
Others
|
1
|
1
|
1
|
Baseline Characteristics
Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Baseline characteristics by cohort
| Measure |
Lot 1
n=298 Participants
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
|
Lot 2
n=303 Participants
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
|
Lot 3
n=304 Participants
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
|
Total
n=905 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=130 Participants
|
41 Participants
n=132 Participants
|
52 Participants
n=130 Participants
|
143 Participants
n=392 Participants
|
|
PCR, n (%)
Negative
|
282 Participants
n=130 Participants
|
288 Participants
n=132 Participants
|
289 Participants
n=130 Participants
|
859 Participants
n=392 Participants
|
|
PCR, n (%)
Missing
|
9 Participants
n=130 Participants
|
7 Participants
n=132 Participants
|
9 Participants
n=130 Participants
|
25 Participants
n=392 Participants
|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 8.31 • n=130 Participants
|
36.5 years
STANDARD_DEVIATION 8.80 • n=132 Participants
|
36.6 years
STANDARD_DEVIATION 8.06 • n=130 Participants
|
36.4 years
STANDARD_DEVIATION 8.39 • n=392 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=130 Participants
|
165 Participants
n=132 Participants
|
186 Participants
n=130 Participants
|
526 Participants
n=392 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=130 Participants
|
138 Participants
n=132 Participants
|
118 Participants
n=130 Participants
|
379 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
245 Participants
n=130 Participants
|
259 Participants
n=132 Participants
|
248 Participants
n=130 Participants
|
752 Participants
n=392 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
4 Participants
n=130 Participants
|
10 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=130 Participants
|
1 Participants
n=132 Participants
|
3 Participants
n=130 Participants
|
7 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=130 Participants
|
10 Participants
n=132 Participants
|
9 Participants
n=130 Participants
|
30 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
54 Participants
n=130 Participants
|
61 Participants
n=132 Participants
|
51 Participants
n=130 Participants
|
166 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
3 Participants
n=130 Participants
|
3 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
219 Participants
n=130 Participants
|
223 Participants
n=132 Participants
|
228 Participants
n=130 Participants
|
670 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
9 Participants
n=130 Participants
|
20 Participants
n=392 Participants
|
|
Race/Ethnicity, Customized
Not reported/specified
|
3 Participants
n=130 Participants
|
5 Participants
n=132 Participants
|
1 Participants
n=130 Participants
|
9 Participants
n=392 Participants
|
|
Previous SARS-CoV-2 infection, n (%)
|
17 Participants
n=130 Participants
|
13 Participants
n=132 Participants
|
14 Participants
n=130 Participants
|
44 Participants
n=392 Participants
|
|
PCR, n (%)
Positive
|
7 Participants
n=130 Participants
|
8 Participants
n=132 Participants
|
6 Participants
n=130 Participants
|
21 Participants
n=392 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 29Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.
Outcome measures
| Measure |
Lot 1
n=275 Participants
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
|
Lot 2
n=283 Participants
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
|
Lot 3
n=290 Participants
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
|
|---|---|---|---|
|
Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs]
Baseline (Day 1)
|
34294.3 Elisa Units per mL
Interval 29549.6 to 39800.9
|
36142.6 Elisa Units per mL
Interval 31430.8 to 41560.8
|
33233.4 Elisa Units per mL
Interval 28863.0 to 38265.4
|
|
Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs]
Day 29
|
91945.8 Elisa Units per mL
Interval 82821.7 to 102075.0
|
93084.2 Elisa Units per mL
Interval 84250.8 to 102843.7
|
88811.3 Elisa Units per mL
Interval 86164.5 to 96589.6
|
SECONDARY outcome
Timeframe: Day 29Proportion 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.
Outcome measures
| Measure |
Lot 1
n=275 Participants
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
|
Lot 2
n=283 Participants
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
|
Lot 3
n=290 Participants
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
|
|---|---|---|---|
|
Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR)
|
23.0 Percentage of participants
Interval 18.2 to 28.5
|
21.2 Percentage of participants
Interval 16.5 to 26.5
|
25.4 Percentage of participants
Interval 20.4 to 30.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 29Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 1 and Day 29
Outcome measures
| Measure |
Lot 1
n=275 Participants
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
|
Lot 2
n=283 Participants
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
|
Lot 3
n=290 Participants
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
|
|---|---|---|---|
|
Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT]
Baseline (Day 1)
|
1211.0 geometric mean titers
Interval 1028.9 to 1425.2
|
1289.4 geometric mean titers
Interval 1114.2 to 1492.3
|
1103.7 geometric mean titers
Interval 950.1 to 1282.1
|
|
Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT]
Day 29
|
2838.7 geometric mean titers
Interval 2532.6 to 3181.8
|
2823.5 geometric mean titers
Interval 2529.0 to 3152.4
|
2603.2 geometric mean titers
Interval 2341.2 to 2894.6
|
SECONDARY outcome
Timeframe: Day 29Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 29
Outcome measures
| Measure |
Lot 1
n=275 Participants
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
|
Lot 2
n=283 Participants
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
|
Lot 3
n=290 Participants
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
|
|---|---|---|---|
|
Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR
|
32.4 Percentage of participants
Interval 26.9 to 38.2
|
32.9 Percentage of participants
Interval 27.4 to 38.7
|
35.9 Percentage of participants
Interval 30.3 to 41.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 29hACE2 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
Outcome measures
| Measure |
Lot 1
n=275 Participants
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
|
Lot 2
n=283 Participants
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
|
Lot 3
n=290 Participants
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
|
|---|---|---|---|
|
hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT
Baseline (Day 1)
|
142.3 geometric mean titers
Interval 121.6 to 166.6
|
142.3 geometric mean titers
Interval 127.0 to 170.5
|
128.8 geometric mean titers
Interval 110.9 to 149.5
|
|
hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT
Day 29
|
332.1 geometric mean titers
Interval 299.1 to 368.7
|
329.1 geometric mean titers
Interval 296.9 to 364.8
|
319.1 geometric mean titers
Interval 289.9 to 351.2
|
SECONDARY outcome
Timeframe: Day 29Human 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
Outcome measures
| Measure |
Lot 1
n=275 Participants
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
|
Lot 2
n=283 Participants
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
|
Lot 3
n=290 Participants
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
|
|---|---|---|---|
|
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR
|
20.4 Percentage of participants
Interval 15.8 to 25.8
|
18.6 Percentage of participants
Interval 14.2 to 23.7
|
23.2 Percentage of participants
Interval 18.5 to 28.6
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Number of participants Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)
Outcome measures
| Measure |
Lot 1
n=298 Participants
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
|
Lot 2
n=303 Participants
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
|
Lot 3
n=304 Participants
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
|
|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)
Serious AEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)
MAAEs
|
15 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 29Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose)
Outcome measures
| Measure |
Lot 1
n=298 Participants
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
|
Lot 2
n=303 Participants
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
|
Lot 3
n=304 Participants
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
|
|---|---|---|---|
|
Incidence and Severity of MAAEs Through Day 29
MAAEs
|
15 Participants
|
12 Participants
|
12 Participants
|
|
Incidence and Severity of MAAEs Through Day 29
Related MAAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 29Number of Participants with Unsolicited Treatment-Emergent Adverse Events by COVID-19 throughout the study at Day 29
Outcome measures
| Measure |
Lot 1
n=298 Participants
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
|
Lot 2
n=303 Participants
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
|
Lot 3
n=304 Participants
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
|
|---|---|---|---|
|
Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19
Unsolicited TEAEs
|
15 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19
Related TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Lot 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Lot 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Lot 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lot 1
n=298 participants at risk
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
|
Lot 2
n=303 participants at risk
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
|
Lot 3
n=304 participants at risk
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
|
|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/298 • 29 Days
|
0.33%
1/303 • Number of events 1 • 29 Days
|
0.00%
0/304 • 29 Days
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/298 • 29 Days
|
0.00%
0/303 • 29 Days
|
0.33%
1/304 • Number of events 1 • 29 Days
|
Other adverse events
| Measure |
Lot 1
n=298 participants at risk
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
|
Lot 2
n=303 participants at risk
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
|
Lot 3
n=304 participants at risk
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
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.3%
7/298 • Number of events 7 • 29 Days
|
0.99%
3/303 • Number of events 3 • 29 Days
|
1.3%
4/304 • Number of events 4 • 29 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
- Publication restrictions are in place
Restriction type: OTHER