COVID-19
Conditions
Brief summary
This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5. The main focus is on safety: researchers want to see if this new booster is safe for teenagers who have already received two doses of the Pfizer or Moderna mRNA COVID-19 vaccines. To ensure a fair comparison, the study will use a double-blind approach. This means two groups of teenagers will receive booster shots, but neither the teenagers nor the researchers giving the shots will know beforehand which version of the booster each person gets. The study will also assess how well the body fights the virus after the booster shot.
Detailed description
This is a Phase 3, randomized, double-blinded study to evaluate the safety and immunogenicity of booster doses of Omicron subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines (SARS-CoV-2 rS) adjuvanted with Matrix-M™ adjuvant (NVX-CoV2601 \[Omicron XBB.1.5\]) and bivalent (NVX-CoV2373 \[prototype\] + NVX CoV2601) in previously vaccinated adolescent participants ≥ 12 to \< 18 years of age. Approximately 400 adolescents who have received a regimen of ≥ 2 doses of the Moderna and/or Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines ≥ 90 days previously will be randomized 1:1 to Group A or Group B: * Group A: 1 dose of NVX-CoV2601 (1 on Day 0) * Group B: 1 dose of bivalent NVX-CoV2373 + NVX-CoV2601 (1 on Day 0) All participants will remain on study for immunogenicity and safety data collection through Day 180.
Interventions
BIOLOGICALNVX-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.
BIOLOGICALPrototype/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.
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adolescents ≥ 12 to \< 18 years of age at screening 2. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give in-formed consent and assent, as required, prior to study enrollment and to comply with study procedures. 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 post-menopausal \[defined as amenorrhea ≥ 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study. 4. Is medically stable, as determined by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and targeted physical examination \[to include body weight\]). Vital signs must be within medically acceptable ranges prior to the vaccination. 5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study. 6. Have previously received ≥ 2 doses of the Moderna and/or Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines with the last dose having been given ≥ 90 days previously prior to study vaccination.
Exclusion criteria
1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines. 2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination. 3. Received influenza vaccination within 14 days prior to study vaccination. 4. Received any vaccine ≤ 45 days prior to study vaccination, except for rabies, human papilloma virus (HPV), tetanus-diphtheria (Td), tetanus, diphtheria, and pertussis (TDaP/DTap), hepatitis B virus (HBV), and meningococcal vaccines which may be given as medically indicated. 5. Any known allergies to products contained in the investigational product. 6. Any history of anaphylaxis to any prior vaccine. 7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. 8. Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted. 9. 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. 10. Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study. 12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 13. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 14. 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). 15. Participants with a history of myocarditis or pericarditis. 16. Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing). 17. Temperature of \> 38°C within 24 hours of planned study vaccination (site measured or participant measured). 18. Blood pressure of ≥ 160/100 mmHg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. | Day 28 | 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 |
| Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Day 7 | 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 |
| Participants With Unsolicited AEs Through 28 Days After Vaccination | Day 28 | Participants with unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination. |
| Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs) | Day 180 | Participants with medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS). |
| Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 0 and Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 0 to Day 180 | 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. |
| Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. | Day 28 to Day 180 | 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. |
| IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein. | Day 0 to Day 180 | 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. |
| NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 0 to 180 | 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 . |
| Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 0 to Day 180 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 190 |
| 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. | 210 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Early termination | 3 | 9 |
Baseline characteristics
| Characteristic | Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Total | Group-A NVX-CoV2601 |
|---|---|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 1.65 | 14.5 years STANDARD_DEVIATION 1.05 | 14.5 years STANDARD_DEVIATION 1.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants | 90 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 310 Participants | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 77 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 149 Participants | 286 Participants | 137 Participants |
| Sex: Female, Male Female | 107 Participants | 206 Participants | 99 Participants |
| Sex: Female, Male Male | 103 Participants | 194 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 190 | 0 / 210 |
| other Total, other adverse events | 10 / 190 | 4 / 210 |
| serious Total, serious adverse events | 7 / 190 | 1 / 210 |
Outcome results
Primary
Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
The neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain assessed at Day 28 following initial study vaccination.
Time frame: Day 0 and Day 28
Population: Per Protocol Neutralization Assay Subset Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 0 | 184.81 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Immunogenicity Index- Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 28 | 1544.61 geometric mean titer |
Primary
Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
the neutralizing antibody (NAb) response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain, assessed at Day 28
Time frame: Day 28
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group-A NVX-CoV2601 | 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 |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Immunogenicity Index- The Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. | 8.4 geometric mean fold rise |
Primary
Participants With (MAAEs) Attributed to Study Vaccine, (AESIs) (PIMMCs), Myocarditis and/or Pericarditis, and Complications Specific to COVID-19), and Serious Adverse Events (SAEs)
Participants with medically attended adverse events (MAAEs) attributed to study vaccine, adverse events of special interest (AESIs) (predefined list including potential immune-mediated medical conditions (PIMMCs), myocarditis and/or pericarditis, and complications specific to COVID-19), and serious adverse events (SAEs) o assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601)through day 180 or end of study (EOS).
Time frame: Day 180
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | 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 |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | 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 | 1 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | 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 | 12 participants |
Primary
Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination
Participants with solicited local and systemic adverse events (AEs) To assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) for 7 days following vaccination
Time frame: Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group-A NVX-CoV2601 | Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited AEs | 153 participants |
| Group-A NVX-CoV2601 | Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Local AEs | 136 participants |
| Group-A NVX-CoV2601 | Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Systemic AEs | 116 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Any Solicited AEs | 166 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Local AEs | 140 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Solicited Local and Systemic AEs for 7 Days Following Vaccination | Systemic AEs | 120 participants |
Primary
Participants With Unsolicited AEs Through 28 Days After Vaccination
Participants with unsolicited AEs to assess the overall safety of 1 heterologous booster dose of NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) through 28 days after vaccination.
Time frame: Day 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Psychiatric disorders | 4 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Injury, poisoning and procedural complications | 2 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Respiratory, thoracic and mediastinal disorders | 2 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Blood and lymphatic system disorders | 1 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Infections and infestations | 15 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Musculoskeletal and connective tissue disorders | 1 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Gastrointestinal disorders | 3 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Nervous system disorders | 0 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | General disorders and administration site conditions | 3 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Metabolism and nutrition disorders | 0 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Skin and subcutaneous tissue disorders | 2 participants |
| Group-A NVX-CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Any unsolicited TEAE through 28 days after study vaccination | 25 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Skin and subcutaneous tissue disorders | 1 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Infections and infestations | 13 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Psychiatric disorders | 2 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | General disorders and administration site conditions | 3 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Respiratory, thoracic and mediastinal disorders | 3 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Gastrointestinal disorders | 1 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Any unsolicited TEAE through 28 days after study vaccination | 25 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Injury, poisoning and procedural complications | 0 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Blood and lymphatic system disorders | 1 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Musculoskeletal and connective tissue disorders | 1 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Nervous system disorders | 1 participants |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Participants With Unsolicited AEs Through 28 Days After Vaccination | Metabolism and nutrition disorders | 1 participants |
Secondary
IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein.
The immunoglobulin G (IgG) antibody levels induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time.at relevant time points.
Time frame: Day 0 to Day 180
Population: Per Protocol Anti-S Protein IgG Serology Subset Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein. | Day 90 | 87102.4 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein. | Day 0 | 32881.9 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein. | Day 180 | 61647.7 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | IgG Geometric Mean ELISA (Enzyme-linked Immunosorbent Assay) Units (GMEUs) to the Omicron XBB.1.5 S Protein. | Day 28 | 113031.9 Elisa Units per mL |
Secondary
NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain .
The NAb antibody responses induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the ancestral (Wuhan) strain at relevant time points .
Time frame: Day 0 to 180
Population: Per Protocol Neutralization Assay Subset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group-A NVX-CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 28 | 3510.84 geometric mean titer |
| Group-A NVX-CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 90 | 3381.08 geometric mean titer |
| Group-A NVX-CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 180 | 2663.87 geometric mean titer |
| Group-A NVX-CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 0 | 1321.00 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 0 | 1197.59 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 28 | 2803.80 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 180 | 2357.51 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | NAb(Neutralizing Antibody Titers) Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 90 | 2924.82 geometric mean titer |
Secondary
Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain.
The neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points.
Time frame: Day 28 to Day 180
Population: Per Protocol Neutralization Assay Subset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-A NVX-CoV2601 | 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 |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. | Day 90 | 6.2 geometric mean fold rise |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. | Day 180 | 4.7 geometric mean fold rise |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Fold Rise (GMFR) to the Omicron XBB.1.5 Strain. | Day 28 | 8.4 geometric mean fold rise |
Secondary
Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain.
the neutralizing antibody NAb response induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the Omicron XBB.1.5 strain over time. at relevant time points.
Time frame: Day 0 to Day 180
Population: Per Protocol Neutralization Assay Subset Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group-A NVX-CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 0 | 204.98 geometric mean titer |
| Group-A NVX-CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 28 | 2533.08 geometric mean titer |
| Group-A NVX-CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 90 | 1816.50 geometric mean titer |
| Group-A NVX-CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 180 | 1369.61 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 180 | 866.10 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 0 | 183.37 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 90 | 1171.90 geometric mean titer |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Neutralizing Antibody (NAb) Expressed as Geometric Mean Titers (GMTs) to the Omicron XBB.1.5 Strain. | Day 28 | 1544.61 geometric mean titer |
Secondary
Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain .
The serum IgG antibody responses induced by NVX CoV2601 and the bivalent vaccine (NVX CoV2373 + NVX-CoV2601) against the ancestral (Wuhan) strain at relevant time points.
Time frame: Day 0 to Day 180
Population: Per Protocol Anti-S Protein IgG Serology Subset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group-A NVX-CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 0 | 71388.4 Elisa Units per mL |
| Group-A NVX-CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 28 | 181736.6 Elisa Units per mL |
| Group-A NVX-CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 90 | 142032.4 Elisa Units per mL |
| Group-A NVX-CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 180 | 104890.2 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 180 | 94026.0 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 0 | 61296.9 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 90 | 130155.1 Elisa Units per mL |
| Group-B Bivalent NVX CoV2373 + NVX CoV2601 | Serum IgG GMEUs Levels Are Measured to the Ancestral (Wuhan) Strain . | Day 28 | 157077.8 Elisa Units per mL |