COVID-19
Conditions
Brief summary
This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccine(s) with Matrix-M™ adjuvant (ancestral strain NVX-CoV2373 and an alternative strain and/or multivalent Novavax vaccine) as booster doses following a series of primary and booster doses of authorized/approved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study (NCT05463068).
Detailed description
This Phase 3 study investigates the immunogenicity and safety of Novavax's NVX-CoV2373 vaccine (including its Matrix-M adjuvant) as an additional booster dose for adults aged 18 to 49. Participants must have already received both their primary mRNA vaccine series and at least one booster dose of the same type. All participants were previously enrolled in Study 307 (NCT05463068), where they received either their primary mRNA vaccines with or without an additional mRNA booster, followed by a single NVX-CoV2373 booster. The study involves up to 300 volunteers who will receive a single dose of the Novavax vaccine (5 micrograms of recombinant spike protein antigen and 50 micrograms of Matrix-M adjuvant) on Day 1.
Interventions
BIOLOGICALNVX-CoV2373
1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1
BIOLOGICALSARS-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
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
To be included in this study, each individual must satisfy all the following criteria: 1. Adults 18 to 49 years (inclusive) of age at the time of vaccination in Study 307 who received two or three doses of mRNA prior to enrollment in Study 307, then one dose of ancestral strain NVX-CoV2373 in Study 307. 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit. 4. Is medically stable, as determined by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and physical examination \[to include body weight\]). Vital signs must be within medically acceptable ranges prior to the study vaccination. 5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted. 6. Documented receipt of COVID-19 vaccines. The most recent dose of NVX-CoV2373 must have been administered at least 180 days prior to vaccination in this study.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the study. 1. Received any additional COVID-19 vaccine booster after the Day 1 dose of NVX-CoV2373 administered during participation in Study 307. 2. History of laboratory-confirmed (by polymerase chain reaction \[PCR\] or rapid antigen test) COVID-19 infection ≤ 4 months prior to Day 1. 3. Current participation in research involving receipt of an investigational product (drug/biologic/device). 4. Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product. 5. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. 6. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received \> 4 days prior to study vaccine, or rabies vaccine, which may be received at any time if medically indicated. 7. 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. 8. Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). 9. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit. 10. Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 11. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 12. 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). 13. Participants with a history of myocarditis or pericarditis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT) | Day 28 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Seroconversion Rate (SCR) | Day 28 | 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 28 |
| Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | Serum 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 |
| Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR | Day 28 | Serum 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 |
| Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | 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) | Post Booster Neutralizing Antibody responses GMTs compared with post-first booster results from Study 307 |
| Number of Participants Reported With Medically Attended Adverse Events (MAAEs) | Day 180 | Number of participants reported with Medically Attended Adverse Events (MAAEs) through Day 180 after the vaccine dose. |
| Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR | Day 28 | hACE2 Receptor Binding Inhibition Assay the SARS-CoV-2 ancestral strain spike protein expressed as SCR at Day 28 |
| Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Day 7 | Number of participants reported Solicited Local and Systemic Adverse Events (AEs) in the 7 days following study vaccination. |
| Number of Participants Reported With Serious Adverse Events (SAEs) | Day 1 to Day 180 | Number of participants reported with Serious Adverse Events (SAEs) through Day 180 after the vaccine dose |
| Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | 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) | Post Booster Serum IgG antibody levels expressed GMEUs compared with post-first booster results from Study 307 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 104 |
| 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 | 43 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | NVX-CoV2540(Updated COVID-19 Vaccine) | NVX CoV2373 (Ancestral Strain) |
|---|---|---|---|
| Age, Continuous | 37.75 years STANDARD_DEVIATION 8.58 | 37.2 years STANDARD_DEVIATION 9.2 | 38.3 years STANDARD_DEVIATION 7.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 36 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| PCR, n (%) Missing | 6 Participants | 1 Participants | 5 Participants |
| PCR, n (%) Negative | 140 Participants | 42 Participants | 98 Participants |
| PCR, n (%) Positive | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 38 Participants | 15 Participants | 23 Participants |
| Race/Ethnicity, Customized Not Reported/Specified | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 98 Participants | 25 Participants | 73 Participants |
| Sex: Female, Male Female | 86 Participants | 23 Participants | 63 Participants |
| Sex: Female, Male Male | 61 Participants | 20 Participants | 41 Participants |
| Time between first dose of previous NVX vaccine at Study 307 and Day 1 dose of Study 312 | 288 days STANDARD_DEVIATION 27.77 | 311.0 days STANDARD_DEVIATION 1.85 | 265.0 days STANDARD_DEVIATION 25.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 43 |
| other Total, other adverse events | 2 / 104 | 1 / 43 |
| serious Total, serious adverse events | 0 / 104 | 1 / 43 |
Outcome results
Primary
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT)
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
Time frame: Day 28
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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) | 835.0 titers |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT) | Date of 1st booster dose (Study 307) | 159.5 titers |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT) | Date of 2nd booster dose (Study 312) | 420.7 titers |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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) | 436.0 titers |
Secondary
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR
hACE2 Receptor Binding Inhibition Assay to the NVX-CoV2540(Updated COVID-19 Vaccine) expressed as SCR at Day 28
Time frame: Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR | 1 participants |
Secondary
Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR
hACE2 Receptor Binding Inhibition Assay the SARS-CoV-2 ancestral strain spike protein expressed as SCR at Day 28
Time frame: Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as SCR | 12.6 Percentage of participants |
Secondary
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Seroconversion Rate (SCR)
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 28
Time frame: Day 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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 | 11 participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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 | 11 participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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 | 22 participants |
Secondary
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
Post Booster Neutralizing Antibody responses GMTs compared with post-first booster results from Study 307
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | Day 0 of 1st booster dose (Study 307) | 173.2 geometric mean titer |
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | 28 days after 1st booster dose (Study 307) | 396.6 geometric mean titer |
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | Day 0 of 2nd booster dose (Study 312) | 306.4 geometric mean titer |
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | 28 days after 2nd booster dose (Study 312) | 393.2 geometric mean titer |
Secondary
Neutralizing Antibody Responses (Post-Booster) Expressed as GMT
Post Booster Neutralizing Antibody responses GMTs compared with post-first booster results from Study 307
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | Day 0 of 1st booster dose (Study 307) | 159.5 geometric mean titer |
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | 28 days after 1st booster dose (Study 307) | 436.0 geometric mean titer |
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | Day 0 of 2nd booster dose (Study 312) | 420.7 geometric mean titer |
| NVX CoV2373 (Ancestral Strain) | Neutralizing Antibody Responses (Post-Booster) Expressed as GMT | 28 days after 2nd booster dose (Study 312) | 835.0 geometric mean titer |
Secondary
Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)
Number of participants reported Solicited Local and Systemic Adverse Events (AEs) in the 7 days following study vaccination.
Time frame: Day 7
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Tenderness | 62 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 49 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Swelling | 5 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Malaise | 31 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Pain | 48 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Muscle pain | 43 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Systemic reaction | 69 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Joint pain | 19 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Redness | 7 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Nausea/vomiting | 12 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Fever | 1 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Headache | 40 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Any solicited local reaction | 68 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Headache | 13 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Any solicited local reaction | 31 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Pain | 18 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Tenderness | 29 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Redness | 1 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Swelling | 0 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Systemic reaction | 24 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Fever | 1 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 11 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Malaise | 5 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Muscle pain | 19 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Joint pain | 7 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs) | Nausea/vomiting | 5 Participants |
Secondary
Number of Participants Reported With Medically Attended Adverse Events (MAAEs)
Number of participants reported with Medically Attended Adverse Events (MAAEs) through Day 180 after the vaccine dose.
Time frame: Day 180
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported With Medically Attended Adverse Events (MAAEs) | MAAEs | 5 Participants |
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported With Medically Attended Adverse Events (MAAEs) | Severe MAAEs | 0 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported With Medically Attended Adverse Events (MAAEs) | MAAEs | 1 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported With Medically Attended Adverse Events (MAAEs) | Severe MAAEs | 1 Participants |
Secondary
Number of Participants Reported With Serious Adverse Events (SAEs)
Number of participants reported with Serious Adverse Events (SAEs) through Day 180 after the vaccine dose
Time frame: Day 1 to Day 180
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Number of Participants Reported With Serious Adverse Events (SAEs) | 0 Participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | Number of Participants Reported With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
Post Booster Serum IgG antibody levels expressed GMEUs compared with post-first booster results from Study 307
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | Day 0 of 1st booster dose (Study 307) | 32446.8 geometric mean Elisa Units |
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | 28 days after 1st booster dose (Study 307) | 93636.6 geometric mean Elisa Units |
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | Day 0 of 2nd booster dose (Study 312) | 71336.1 geometric mean Elisa Units |
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | 28 days after 2nd booster dose (Study 312) | 203864.0 geometric mean Elisa Units |
Secondary
Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU
Post Booster Serum IgG antibody levels expressed GMEUs compared with post-first booster results from Study 307
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | Day 0 of 1st booster dose (Study 307) | 37822.4 geometric mean Elisa Units |
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | 28 days after 1st booster dose (Study 307) | 93969.2 geometric mean Elisa Units |
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | Day 0 of 2nd booster dose (Study 312) | 67333.6 geometric mean Elisa Units |
| NVX CoV2373 (Ancestral Strain) | Serum IgG Antibody Levels (Post-Booster) Expressed as GMEU | 28 days after 2nd booster dose (Study 312) | 162144.7 geometric mean Elisa Units |
Secondary
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU)
Serum 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
Time frame: Day 28
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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) | 203864.0 Elisa Units per mL |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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) | 32446.8 Elisa Units per mL |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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) | 71336.1 Elisa Units per mL |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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) | 93636.6 Elisa Units per mL |
Secondary
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR
Serum 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
Time frame: Day 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX CoV2373 (Ancestral Strain) | 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 |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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 | 11 participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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 | 11 participants |
| NVX-CoV2540(Updated COVID-19 Vaccine) | 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 | 22 participants |