Created at Source Raw Value Validated value
Dec. 10, 2021, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The investigational vaccine; IVX-411; is a computationally-designed recombinant protein virus-like particle (VLP) vaccine under development for the prevention of COVID-19 caused by SARS-CoV-2.\u2018IVX-411 study vaccine\u2019 refers to either the aqueous formulation IVX-411a or the adjuvanted formulation IVX-411d. The volume of vaccine formulation to be administered via intramuscular injection is 0.5 mL.It is a Phase 2 assessment of booster vaccination with IVX-411 in up to 84 healthy adults who have been fully vaccinated with a licensed vaccine against SARS-CoV-2.Licensed SARS-CoV-2 vaccine dosing regimen must have been completed within 3 to 6 months prior to study vaccine administration on study Day 0The participants will be randomly allocated to one of six IVX-411 formulations (low; medium or high doses with or without MF59) or to the Placebo arm. IVX-411 will be administered intramuscularly as two doses given 28 days apart.The inclusion of MF59 adjuvant in the vaccine is expected to enhance the immune response and increase the duration of the immune response; which is important in prolonged SARS-CoV-2 circulation and/or ongoing outbreaks.The dose levels of IVX-411 with or without MF59 are 5; 25 or 125 \u00b5g will administer a single booster dose at Day 0Adherence to intervention is not applicable since this is not self-administered and will be administered intramuscularly by trial site personnel as two doses given 28 days apart.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "0.5mL booster dose;IM", "treatment_id": 695, "treatment_name": "Ivx-411", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]

July 16, 2021, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The investigational vaccine; IVX-411; is a computationally-designed recombinant protein virus-like particle (VLP) vaccine under development for the prevention of COVID-19 caused by SARS-CoV-2.\u2018IVX-411 study vaccine\u2019 refers to either the aqueous formulation IVX-411a or the adjuvanted formulation IVX-411d. The volume of vaccine formulation to be administered via intramuscular injection is 0.5 mL.It is a Phase 2 assessment of booster vaccination with IVX-411 in up to 84 healthy adults who have been fully vaccinated with a licensed vaccine against SARS-CoV-2.Licensed SARS-CoV-2 vaccine dosing regimen must have been completed within 3 to 6 months prior to study vaccine administration on study Day 0The participants will be randomly allocated to one of six IVX-411 formulations (low; medium or high doses with or without MF59) or to the Placebo arm. IVX-411 will be administered intramuscularly as two doses given 28 days apart.The inclusion of MF59 adjuvant in the vaccine is expected to enhance the immune response and increase the duration of the immune response; which is important in prolonged SARS-CoV-2 circulation and/or ongoing outbreaks.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]