Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines (COVID-19)

A Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated With Other COVID-19 Vaccines

This is a Multi-Part, Phase 3, randomized, observer-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-CoV2515 [BA.1] and NVX-CoV2540 [BA.5]) and bivalent (NVX-CoV2373 [prototype] + Omicron subvariant) SARS-CoV-2 rS vaccines (NVX-CoV2373 + NVX CoV2515 and NVX CoV2373 + NVX CoV2540) in previously vaccinated adults 18 years of age and older.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS CoV 2 Infection
• Intervention / Treatment: Drug: NVX-CoV2515; Drug: NVX-Cov2373; Drug: NVX-CoV2373 + NVX-CoV2515; Drug: NVX-CoV2540; Drug: NVX-CoV2373 + NVX-CoV2540

• Study Type: Interventional
• Enrollment (Actual): 1340
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Bruce, Australian Capital Territory, Australia, 2617
      • Paratus Clinical Research Canberra
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Research Western Sydney
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research
    • Brookvale, New South Wales, Australia, 2100
      • Northern Beaches Clinical Research
    • Kanwal, New South Wales, Australia, 2291
      • Paratus Clinical Research Central Coast
    • Maroubra, New South Wales, Australia, 2035
      • Australian Clinical Research Network (ACRN)
    • Merewether, New South Wales, Australia, 2291
      • AIM Centre (Hunter Diabetes Centre)
    • Newcastle, New South Wales, Australia, 2289
      • Novatrials
  • New South Whales
    • Sydney, New South Whales, Australia, 2010
      • Holdsworth House Medical Practice
  • Queensland
    • Albion, Queensland, Australia, 4010
      • Paratus Clinical Research Brisbane
    • Milton, Queensland, Australia, 4064
      • Core Research Group Pty Ltd
    • Southport, Queensland, Australia, 4222
      • Griffith University Clinical Trial Unit
    • Taringa, Queensland, Australia, 4068
      • Data Health Australia PTY Ltd t/a Austrials
    • Wellers Hill, Queensland, Australia, 4121
      • AusTrials Wellers Hill
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Clinical Medical and Analytical Excellence (CMAX)
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health-Box Hill Hospital
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • Geelong, Victoria, Australia, 3220
      • University Hospital Geelong-Barwon Health
    • Melbourne, Victoria, Australia, 3168
      • Monash Health -Monash Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Part 1

Inclusion Criteria:

To be included in this study, each individual must satisfy all the following criteria:

1. Adults ≥ 18 and ≤ 64 years of age at screening.
2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
3. Female 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 ≥ 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 and through the end of the study.
4. Is medically stable, as determined by the investigator (based on a 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 COVID-19 prototype vaccines with the last dose having been given ≥ 180 days prior to study vaccination or 3 doses of the Moderna and/or Pfizer-BioNTech COVID-19 prototype vaccines with the last dose having been given ≥ 90 days previously prior to the study vaccination.

Exclusion Criteria:

If an individual meets any of the following criteria, he or she is ineligible for this study:

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 any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccination which may be received > 14 days prior to study vaccination, or rabies vaccine which may be given if medically indicated.
4. Any known allergies to products contained in the investigational product.
5. Any history of anaphylaxis to any prior vaccine.
6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination.
8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to the first study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9. 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).
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of the study.
11. 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.
12. 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).
13. 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).

Part 2

Inclusion Criteria:

To be included in this study, each individual must satisfy all of the following criteria:

1. Adults and adolescents ≥ 18 years of age at screening.
2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
3. Female 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 ≥ 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 first 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 ≥ 3 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 first study booster.

Exclusion Criteria:

If an individual meets any of the following criteria, he or she is ineligible for this study:

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 first study vaccination.
3. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccination which may be received > 14 days prior to first study vaccination, or rabies vaccine which may be given if medically indicated.
4. Any known allergies to products contained in the investigational product.
5. Any history of anaphylaxis to any prior vaccine.
6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9. Active cancer (malignancy) on therapy within 3 years prior to first 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).
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
11. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
12. 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).
13. 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).
14. Participants with a history of myocarditis or pericarditis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (NVX-CoV2515 ); 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.	Drug: NVX-CoV2515; Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).; Other Names: Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant
Experimental: Group B (NVX-CoV2373 ); 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.	Drug: NVX-Cov2373; Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).; Other Names: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Group C (NVX-CoV2515 ); 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.	Drug: NVX-CoV2515; Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).; Other Names: Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant
Experimental: Group D (NVX-CoV2373); 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.	Drug: NVX-Cov2373; Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).; Other Names: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Group E (BA.1 Bivalent Vaccine); 1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0.	Drug: NVX-CoV2373 + NVX-CoV2515; Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.; Other Names: Prototype/BA.1 Bivalent Vaccine
Experimental: Group F (NVX-CoV2540); 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.	Drug: NVX-CoV2540; Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).; Other Names: Omicron BA.5 SARS-CoV-2 rS /Matrix-M Adjuvant
Experimental: Group G (NVX-CoV2373); 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.	Drug: NVX-Cov2373; Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).; Other Names: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Group H (NVX-CoV2373 + NVX-CoV2540); 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.	Drug: NVX-CoV2373 + NVX-CoV2540; Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.; Other Names: Prototype/BA.5 Bivalent Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: MN50 geometric mean titers (GMTs) to the Omicron BA.1 subvariant expressed as GMTs	Microneutralization [MN] geometric mean titers (GMTs) with an inhibitory concentration of 50% (MN50) to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.	Day 14
Part 1: MN50 titer concentrations to the Omicron BA.1 subvariant vaccine expressed as seroresponse rates (SRRs)	Seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline [Day 0]) in MN50 titer concentrations to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.	Day 14
Part 2: Neutralizing Antibody (NAb) GMTs to the Omicron BA.5 subvariant expressed as GMTs	Neutralizing antibody (NAb) GMTs to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination.	Day 28
Part 2: Neutralizing Antibody (NAb) titers to the Omicron BA.5 subvariant expressed as SRRs	SRRs in NAb titer concentrations to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination	Day 28
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) strain expressed as GMTs	NAb GMTs to the ancestral (Wuhan) strain, assessed at Day 28 following initial study vaccination.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan),and Omicron BA.1 viruses expressed as GMT	MN50 GMTs to the ancestral (Wuhan), and Omicron BA.1 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: MN50 titer concentrations to the ancestral (Wuhan), and Omicron BA.1 viruses expressed as GMFR	MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan), and Omicron BA.1 viruses at relevant time points (Days 7, 14, 28, and 240) from baseline (Day 0) and analyzed by previous vaccine combination received.	Day 7 to Day 240
Part 1: MN50 titer concentrations to the ancestral (Wuhan), and Omicron BA.1 viruses expressed as SRRs	SRRs in MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 7 to Day 240
Part 1: Immunoglobulin G (IgG) antibody levels to the ancestral (Wuhan), Omicron BA.1 and Omicron BA.5 viruses expressed as GMT	Immunoglobulin G (IgG) antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combinations received.	Day 0 to Day 240
Part 1:IgG antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR	IgG antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: IgG antibody levels to the ancestral (Wuhan), Omicron BA.1 and Omicron BA.5 viruses expressed as SRRs	IgG antibody levels to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMTs	hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR	hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.	Day 0 to Day 240
Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR	hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.	Day 0 to Day 240
Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMT	MN50 GMTs to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.	Day 14
Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMFR	MN50 GMFRs to the ancestral (Wuhan) virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.	Day 14
Part 1: SRRs in MN50 titer concentrations to the ancestral (Wuhan) virus expressed as SRRs	SRR in MN50 titer concentrations to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination.	Day 14
Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMT	MN50 GMTs to the Omicron BA.1 subvariant virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.	Day 14
Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMFR	MN50 GMFRs to the Omicron BA.1 subvariant virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.	Day 14
Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as SRR	SRR in MN50 titer concentrations to the Omicron BA.1 variant virus, assessed at Day 14 following initial study vaccination.	Day 14
Part 1: IgG Geometric Mean Concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR	IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR	IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR	GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1: GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR	GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.	Day 0 to Day 240
Part 1 and Part 2: Incidence of solicited local and systemic Adverse Events (AEs)	Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination.	Day 7
Part 1 and Part 2 : Incidence of unsolicited AEs	Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after vaccination.	Day 28
Part 1 and Part 2 :Incidence and relationship of Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)	Incidence and relationship of MAAEs, AESIs (predefined list), and SAEs throughout the study	Day 0 to Day 270
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as GMTs	NAb GMTs to the ancestral (Wuhan) and Omicron BA.5 strains at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as GMFRs	NAb GMFR to the ancestral (Wuhan), and Omicron BA.5 strains at relevant time points (Days 14, 28, 104, 118, and 270) from baseline (Day 0 or Day 90) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as SRRs	SRRs in NAb titers to the ancestral (Wuhan) and Omicron BA.5 strains at relevant time points (Days 14, 28, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as GMTs	IgG GMEUs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as GMFRs	IgG GMEUs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as SRRs	IgG GMEUs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan),and Omicron BA.5 S proteins expressed as GMTs	hACE2 receptor binding inhibition assay GMTs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan), and Omicron BA.5 S proteins expressed as GMFRs	hACE2 receptor binding inhibition assay GMTs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270
Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan), and Omicron BA.5 S proteins expressed as SRRs	hACE2 receptor binding inhibition assay GMTs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).	Day 0 to Day 270

Collaborators and Investigators

• Sponsor: Novavax
• Investigators: Study Director: Clinical Development, Novavax, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): July 17, 2022
• Study Completion (Actual): April 7, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Coronavirus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2019nCoV- 311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes