Trial Outcomes & Findings for Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines (NCT NCT05875701)
NCT ID: NCT05875701
Last Updated: 2025-06-26
Results Overview
Neutralizing Antibody responses to ancestral strain Novavax vaccine (NVX-CoV2373) for the participants in the ancestral strain NVX-2373 group and NVX-CoV2540 group at Day 29
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
147 participants
Primary outcome timeframe
Day 28
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
NVX CoV2373 (Ancestral Strain)
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
43
|
|
Overall Study
COMPLETED
|
101
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
NVX CoV2373 (Ancestral Strain)
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines
Baseline characteristics by cohort
| Measure |
NVX CoV2373 (Ancestral Strain)
n=104 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=43 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
37.75 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported/Specified
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Time between first dose of previous NVX vaccine at Study 307 and Day 1 dose of Study 312
|
265.0 days
STANDARD_DEVIATION 25.92 • n=5 Participants
|
311.0 days
STANDARD_DEVIATION 1.85 • n=7 Participants
|
288 days
STANDARD_DEVIATION 27.77 • n=5 Participants
|
|
PCR, n (%)
Positive
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PCR, n (%)
Negative
|
98 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
PCR, n (%)
Missing
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Per Protocol Analysis Set
Neutralizing Antibody responses to ancestral strain Novavax vaccine (NVX-CoV2373) for the participants in the ancestral strain NVX-2373 group and NVX-CoV2540 group at Day 29
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=40 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT)
Date of 1st booster dose (Study 307)
|
173.2 titers
Interval 123.0 to 243.8
|
159.5 titers
Interval 94.3 to 269.9
|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT)
28 days after 1st booster dose (Study 307)
|
396.6 titers
Interval 328.7 to 478.6
|
436.0 titers
Interval 305.6 to 622.2
|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT)
Date of 2nd booster dose (Study 312)
|
306.4 titers
Interval 222.6 to 421.6
|
420.7 titers
Interval 282.5 to 626.6
|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT)
28 days after 2nd booster dose (Study 312)
|
393.2 titers
Interval 318.0 to 486.2
|
835.0 titers
Interval 597.1 to 1167.6
|
SECONDARY outcome
Timeframe: Day 28Neutralizing Antibody responses to ancestral strain Novavax vaccine (NVX-CoV2373) for the participants in the ancestral strain NVX-2373 group and NVX-CoV2540 group at Day 28
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=40 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Seroconversion Rate (SCR)
28 days after 1st booster relative to date of 1st booster
|
24 participants
|
11 participants
|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Seroconversion Rate (SCR)
28 days after 2nd booster relative to date of 2nd booster
|
21 participants
|
11 participants
|
|
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Seroconversion Rate (SCR)
28 days after 2nd booster relative to date of 1st booster
|
31 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Day 28Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) in Ancestral strain NVX-CoV2373 group and updated NVX Vaccine group at Day 28
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=40 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU)
Date of 1st booster dose (Study 307)
|
37822.4 Elisa Units per mL
Interval 29104.7 to 49151.4
|
32446.8 Elisa Units per mL
Interval 22453.4 to 46888.0
|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU)
28 days after 1st booster dose (Study 307)
|
93969.2 Elisa Units per mL
Interval 79844.0 to 110593.4
|
93636.6 Elisa Units per mL
Interval 69077.5 to 126927.1
|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU)
Date of 2nd booster dose (Study 312)
|
67333.6 Elisa Units per mL
Interval 54380.8 to 83371.6
|
71336.1 Elisa Units per mL
Interval 50460.2 to 100848.6
|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU)
28 days after 2nd booster dose (Study 312)
|
162144.7 Elisa Units per mL
Interval 136476.6 to 192640.4
|
203864.0 Elisa Units per mL
Interval 148535.6 to 279801.8
|
SECONDARY outcome
Timeframe: Day 28Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) in Ancestral strain NVX-CoV2373 group and updated NVX Vaccine group at Day 28
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=40 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR
28 days after 1st booster relative to date of 1st booster
|
22 participants
|
11 participants
|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR
28 days after 2nd booster relative to date of 2nd booster
|
22 participants
|
11 participants
|
|
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR
28 days after 2nd booster relative to date of 1st booster
|
45 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of Study 307 and Study 312 (approximately 1 year from Day 0 of Study 307 and Day 0 of Study 312)Population: Study 307 results represent results from a prior study in which participants took part in. Study 312 refers to the study in this specific record.
Post Booster Neutralizing Antibody responses GMTs compared with post-first booster results from Study 307
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
Day 0 of 1st booster dose (Study 307)
|
173.2 geometric mean titer
Interval 123.0 to 243.8
|
—
|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
28 days after 1st booster dose (Study 307)
|
396.6 geometric mean titer
Interval 328.7 to 478.6
|
—
|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
Day 0 of 2nd booster dose (Study 312)
|
306.4 geometric mean titer
Interval 222.6 to 421.6
|
—
|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
28 days after 2nd booster dose (Study 312)
|
393.2 geometric mean titer
Interval 318.0 to 486.2
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of Study 307 and Study 312 (approximately 1 year from Day 0 of Study 307 and Day 0 of Study 312)Population: Study 307 results represent results from a prior study in which participants took part in. Study 312 refers to the study in this specific record.
Post Booster Serum IgG antibody levels expressed GMEUs compared with post-first booster results from Study 307
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
Day 0 of 1st booster dose (Study 307)
|
37822.4 geometric mean Elisa Units
Interval 29104.7 to 49151.4
|
—
|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
28 days after 1st booster dose (Study 307)
|
93969.2 geometric mean Elisa Units
Interval 79844.0 to 110593.4
|
—
|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
Day 0 of 2nd booster dose (Study 312)
|
67333.6 geometric mean Elisa Units
Interval 54380.8 to 83371.6
|
—
|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
28 days after 2nd booster dose (Study 312)
|
162144.7 geometric mean Elisa Units
Interval 136476.6 to 192640.4
|
—
|
SECONDARY outcome
Timeframe: Day 28hACE2 Receptor Binding Inhibition Assay the SARS-CoV-2 ancestral strain spike protein expressed as SCR at Day 28
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=98 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR
|
12.6 Percentage of participants
Interval 5.9 to 21.2
|
—
|
SECONDARY outcome
Timeframe: Day 7Number of participants reported Solicited Local and Systemic Adverse Events (AEs) in the 7 days following study vaccination.
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=104 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=43 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Any solicited local reaction
|
68 Participants
|
31 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Pain
|
48 Participants
|
18 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Tenderness
|
62 Participants
|
29 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Redness
|
7 Participants
|
1 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Swelling
|
5 Participants
|
0 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Systemic reaction
|
69 Participants
|
24 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Fever
|
1 Participants
|
1 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Fatigue
|
49 Participants
|
11 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Malaise
|
31 Participants
|
5 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Muscle pain
|
43 Participants
|
19 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Joint pain
|
19 Participants
|
7 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Nausea/vomiting
|
12 Participants
|
5 Participants
|
|
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Headache
|
40 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 180Number of participants reported with Medically Attended Adverse Events (MAAEs) through Day 180 after the vaccine dose.
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=104 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=43 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Number of Participants Reported With Medically Attended Adverse Events (MAAEs)
MAAEs
|
5 Participants
|
1 Participants
|
|
Number of Participants Reported With Medically Attended Adverse Events (MAAEs)
Severe MAAEs
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 180Number of participants reported with Serious Adverse Events (SAEs) through Day 180 after the vaccine dose
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=104 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=43 Participants
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Number of Participants Reported With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of Study 307 and Study 312 (approximately 1 year from Day 0 of Study 307 and Day 0 of Study 312)Population: Study 307 results represent results from a prior study in which participants took part in. Study 312 refers to the study in this specific record.
Post Booster Neutralizing Antibody responses GMTs compared with post-first booster results from Study 307
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=40 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
Day 0 of 1st booster dose (Study 307)
|
159.5 geometric mean titer
Interval 94.3 to 269.9
|
—
|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
28 days after 1st booster dose (Study 307)
|
436.0 geometric mean titer
Interval 305.6 to 622.2
|
—
|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
Day 0 of 2nd booster dose (Study 312)
|
420.7 geometric mean titer
Interval 282.5 to 626.6
|
—
|
|
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
28 days after 2nd booster dose (Study 312)
|
835.0 geometric mean titer
Interval 597.1 to 1167.6
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Day 28 of Study 307 and Study 312 (approximately 1 year from Day 0 of Study 307 and Day 0 of Study 312)Population: Study 307 results represent results from a prior study in which participants took part in. Study 312 refers to the study in this specific record.
Post Booster Serum IgG antibody levels expressed GMEUs compared with post-first booster results from Study 307
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=40 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
Day 0 of 1st booster dose (Study 307)
|
32446.8 geometric mean Elisa Units
Interval 22453.4 to 46888.0
|
—
|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
28 days after 1st booster dose (Study 307)
|
93636.6 geometric mean Elisa Units
Interval 69077.5 to 126927.1
|
—
|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
Day 0 of 2nd booster dose (Study 312)
|
71336.1 geometric mean Elisa Units
Interval 50460.2 to 100848.6
|
—
|
|
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
28 days after 2nd booster dose (Study 312)
|
203864.0 geometric mean Elisa Units
Interval 148535.6 to 279801.8
|
—
|
SECONDARY outcome
Timeframe: Day 28hACE2 Receptor Binding Inhibition Assay to the NVX-CoV2540(Updated COVID-19 Vaccine) expressed as SCR at Day 28
Outcome measures
| Measure |
NVX CoV2373 (Ancestral Strain)
n=40 Participants
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR
|
1 participants
|
—
|
Adverse Events
NVX CoV2373 (Ancestral Strain)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
NVX-CoV2540(Updated COVID-19 Vaccine)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NVX CoV2373 (Ancestral Strain)
n=104 participants at risk
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=43 participants at risk
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/104 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
NVX CoV2373 (Ancestral Strain)
n=104 participants at risk
1dose of NVX-COV2373 on Day 1
NVX-CoV2373: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
NVX-CoV2540(Updated COVID-19 Vaccine)
n=43 participants at risk
1dose of updated COVID-19 vaccine on Day 1
SARS-CoV-2 rS antigen/Matrix-M Adjuvant: 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/104 • 6 months
|
2.3%
1/43 • Number of events 1 • 6 months
|
|
Infections and infestations
COVID-19
|
1.9%
2/104 • Number of events 2 • 6 months
|
0.00%
0/43 • 6 months
|
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