COVID-19: Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines
Study Details
Study Description
Brief Summary
This is a 2 part, Phase 3, randomized, observer-blinded, study to evaluate the safety and immunogenicity of 2 booster doses of the Omicron subvariant and a bivalent SARS-CoV-2 rS (NVXCoV2373 + NVX-CoV2515) in previously vaccinated adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This 2-Part study is designed to assess the immune responses induced by the Novavax Omicron BA.1 and BA.5 subvariant vaccines (NVX CoV2515 and NVX-CoV2540, respectively) alone or in combination with the prototype Novavax vaccine (NVX-CoV2373) as bivalent products and to compare responses to that of the prototype Novavax vaccine (NVX-CoV2373) in adult participants ≥ 18 and ≤ 64 years of age who previously received 2, 3, or ≥ 3 doses of approved mRNA prototype vaccines.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A (NVX-CoV2515 / NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0 and 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on day 150. |
Drug: NVX-CoV2515
Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL) on Day 0 and Day 150.
Other Names:
Drug: NVX-Cov2540
Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group B (NVX-CoV2373 ) 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 150 for randomized participants. |
Drug: NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group B1 (NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on Day 150 for randomized participants. |
Drug: NVX-Cov2540
Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group C (NVX-CoV2515 / NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0 and 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on day 150. |
Drug: NVX-CoV2515
Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL) on Day 0 and Day 150.
Other Names:
Drug: NVX-Cov2540
Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group D (NVX-CoV2373) 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and Day 150. |
Drug: NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group D1 (NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on Day 150 for randomized participants. |
Drug: NVX-Cov2540
Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group E (BA.1 Bivalent Vaccine ) 2 intramuscular (IM) injections of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0 and Day 150. |
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 on Day 0 and Day 150.
Other Names:
|
| Experimental: Group F (NVX-CoV2540) 2 intramuscular (IM) injections of NVX-CoV2540 of 0.5 mL injection volume on Day 0 and Day 150. |
Drug: NVX-Cov2540
Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group G (BA.5 Bivalent Vaccine ) 2 intramuscular (IM) injections of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2540) of 0.5 mL injection volume on Day 0 and Day 150. |
Drug: NVX-CoV2373 + NVX-CoV2540
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2540) with 50 µg Matrix-M adjuvant on Day 0 and Day 150.
Other Names:
|
| Experimental: Group H (NVX-CoV2373) 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and Day 150 for randomized participants. |
Drug: NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
| Experimental: Group H1 (NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on Day 150 for randomized participants. |
Drug: NVX-Cov2540
Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL) on Day 0 and Day 150.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Part 1: MN50 geometric mean titers (GMTs) to the Omicron BA.1 subvariant expressed as GMTs [Day 14]
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.
- Part 1: MN50 titer concentrations to the Omicron BA.1 subvariant vaccine expressed as seroresponse rates (SRRs) [Day 14]
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.
- Part 2: MN50 geometric mean titers (GMTs) to the Omicron BA.5 subvariant expressed as GMTs [Day 14]
MN50 GMTs to the Omicron BA.5 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
- Part 2: MN50 geometric mean titers (GMTs) to the Omicron BA.5 subvariant expressed as SRRs [Day 14]
SRRs in MN50 titer concentrations to the Omicron BA.5 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
Secondary Outcome Measures
- Part 1: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMT [Day 0 to Day 150]
MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 150) and analyzed by previous vaccine combination received.
- Part 1: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [Day 7 to Day 150]
MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 7, 14, 28, and 150) from baseline (Day 0) and analyzed by previous vaccine combination received.
- Part 1: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRRs [Day 7 to Day 150]
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 150) and analyzed by previous vaccine combination received.
- Part 1: MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses expressed as GMT [Day 150 to Day 270]
MN50 GMTs to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
- Part 1: MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses expressed as GMFR [Day 150 to Day 270]
MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 150, 164, 249, and 270) from baseline (Day 150) and analyzed by previous vaccine combination received.
- Part 1: MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses expressed as SRRs [Day 150 to Day 270]
SRRs in MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
- Part 1: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [Day 0 to Day 270]
IgG geometric mean concentrations (GMCs, EU/mL) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
- Part 1: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRRs [Day 0 to Day 270]
IgG geometric mean concentrations (GMCs, EU/mL) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRR.
- Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMTs [Day 0 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
- Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [Day 0 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
- Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [Day 0 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
- Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMT [Day 14]
MN50 GMTs to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
- Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMFR [Day 14]
MN50 GMFRs to the ancestral (Wuhan) virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
- Part 1: SRRs in MN50 titer concentrations to the ancestral (Wuhan) virus expressed as SRRs [Day 14]
SRR in MN50 titer concentrations to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination.
- Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMT [Day 14]
MN50 GMTs to the Omicron BA.1 subvariant virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
- Part 1: IgG GMCs to the to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [Day 0 to Day 270]
IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
- Part 1: IgG GMCs to the to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [Day 0 to Day 270]
IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
- Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMFR [Day 14]
MN50 GMFRs to the Omicron BA.1 subvariant virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
- Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as SRR [Day 14]
SRR in MN50 titer concentrations to the Omicron BA.1 variant virus, assessed at Day 14 following initial study vaccination.
- Part 2: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMT [Day 0 to Day 270]
MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
- Part 2: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [Day 7 to Day 270]
MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 7, 14, 28, 150, 164, 249, and 270) from baseline (Day 0 or 150) and analyzed by previous vaccine combination received.
- Part 2: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRRs [Day 7 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
- Part 2: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [Day 0 to Day 270]
IgG geometric mean concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
- Part 2: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRRs [Day 0 to Day 270]
IgG geometric mean concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
- Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMTs [Day 0 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
- Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRR [Day 0 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
- Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [Day 0 to Day 270]
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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
- Part 2: MN50 GMTs to the ancestral (Wuhan) virus expressed as GMFR [Day 14]
MN50 GMFRs to the ancestral (Wuhan) virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
- Part 2: MN50 GMTs to the ancestral (Wuhan) virus expressed as GMT [Day 14]
MN50 GMTs to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
- Part 2: MN50 titer concentrations to the ancestral (Wuhan) virus expressed as GMFR [Day 14]
SRR in MN50 titer concentrations to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination.
- Part 2: MN50 GMTs to the Omicron BA.5 virus expressed as GMTs [Day 14]
MN50 GMTs to the Omicron BA.5 virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
- Part 2: MN50 titer concentrations to the Omicron BA.5 virus expressed as GMFR [Day 14]
MN50 GMFRs to the Omicron BA.5 virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
- Part 2: MN50 titer concentrations to the Omicron BA.5 virus expressed as SRR [Day 14]
SRR in MN50 titer concentrations to the Omicron BA.5 virus, assessed at Day 14 following initial study vaccination.
- Part 2: MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [Day 0 to Day 270]
MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR
- Part 2: MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRR [Day 0 to Day 270]
MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRR
- Part 2: IgG GMC to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [Day 0 to Day 270]
IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
- Part 1 and Part 2: Incidence of solicited local and systemic AEs [Day 7]
Incidence, duration, and severity of solicited local and systemic AEs for 7 days following each vaccination.
- Part 1 and Part 2 : Incidence of unsolicited AEs [Day 28]
Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination.
- Part 1 and Part 2 :Incidence and relationship of MAAEs, AESIs, and SAEs [Day 0 to Day 270]
Incidence and relationship of MAAEs, AESIs (predefined list), and SAEs throughout the study
- Part 2: IgG GMC to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [Day 0 to Day 270]
IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRR.
- Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [Day 0 to Day 270]
GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
Eligibility Criteria
Criteria
Inclusion Criteria:
To be included in this study, each individual must satisfy all the following criteria:
-
Adults ≥ 18 and ≤ 64 years of age at screening.
-
Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
-
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.
-
Condoms (male or female) with spermicide (if acceptable in country)
-
Diaphragm with spermicide
-
Cervical cap with spermicide
-
Intrauterine device
-
Oral or patch contraceptives
-
Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
-
Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
-
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.
-
Agrees 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.
- Have previously received ≥ 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 first study booster.
Exclusion Criteria:
If an individual meets any of the following criteria, he or she is ineligible for this study:
-
Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
-
Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
-
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.
-
Any known allergies to products contained in the investigational product.
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Any history of anaphylaxis to any prior vaccine.
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Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis) are NOT excluded.
-
Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination. NOTE: 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. Use of inhaled glucocorticoids is prohibited.
-
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.
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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).
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Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
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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.
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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).
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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).
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Participants with a history of myocarditis or pericarditis
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Confirmed case (by PCR or rapid test) of symptomatic COVID-19 in the past 60 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Paratus Clinical Research Canberra | Bruce | Australian Capital Territory | Australia | 2617 |
| 2 | Paratus Clinical Research Western Sydney | Blacktown | New South Wales | Australia | 2148 |
| 3 | Emeritus Research | Botany | New South Wales | Australia | 2019 |
| 4 | Northern Beaches Clinical Research | Brookvale | New South Wales | Australia | 2100 |
| 5 | Paratus Clinical Research Central Coast | Kanwal | New South Wales | Australia | 2291 |
| 6 | Australian Clinical Research Network (ACRN) | Maroubra | New South Wales | Australia | 2035 |
| 7 | AIM Centre (Hunter Diabetes Centre) | Merewether | New South Wales | Australia | 2291 |
| 8 | Novatrials | Newcastle | New South Wales | Australia | 2289 |
| 9 | Holdsworth House Medical Practice | Sydney | New South Whales | Australia | 2010 |
| 10 | Paratus Clinical Research Brisbane | Albion | Queensland | Australia | 4010 |
| 11 | Core Research Group Pty Ltd | Milton | Queensland | Australia | 4064 |
| 12 | Griffith University Clinical Trial Unit | Southport | Queensland | Australia | 4222 |
| 13 | Data Health Australia PTY Ltd t/a Austrials | Taringa | Queensland | Australia | 4068 |
| 14 | AusTrials Wellers Hill | Wellers Hill | Queensland | Australia | 4121 |
| 15 | Clinical Medical and Analytical Excellence (CMAX) | Adelaide | South Australia | Australia | 5000 |
| 16 | Eastern Health-Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
| 17 | Emeritus Research | Camberwell | Victoria | Australia | 3124 |
| 18 | University Hospital Geelong-Barwon Health | Geelong | Victoria | Australia | 3220 |
| 19 | Monash Health -Monash Medical Centre | Melbourne | Victoria | Australia | 3168 |
Sponsors and Collaborators
- Novavax
Investigators
- Study Director: Clinical Development, Novavax, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019nCoV- 311