Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant]: Adult cohort: Phase 2 part: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant] Manufacturer: DS manufactured by Novavax and DP (fill finish) by SIIPL.Phase 3 part:COVOVAX; Manufacturer: Serum Institute of India Pvt. Ltd.Pediatric cohort: Test vaccine: COVOVAX; DS and DP manufactured by SIIPLControl Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant: Adult Cohort: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant. DS and DP manufactured by NovavaxControl Intervention2: Placebo: Adult Cohort (Phase 2 part) and Pediatric Cohort: Placebo: 0.9% Normal saline (Sodium chloride) for injection.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant]: Adult cohort: Phase 2 part: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant] Manufacturer: DS manufactured by Novavax and DP (fill finish) by SIIPL.Phase 3 part:COVOVAX; Manufacturer: Serum Institute of India Pvt. Ltd.Pediatric cohort: Test vaccine: COVOVAX; DS and DP manufactured by SIIPLControl Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant: Adult Cohort: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant. DS and DP manufactured by NovavaxControl", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Control Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant: Adult Cohort: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant. DS and DP manufactured by NovavaxControl Intervention2: Placebo: Adult Cohort (Phase 2 part) and Pediatric Cohort: Placebo: 0.9% Normal saline (Sodium chloride) for injection.", "treatment_type": "Placebo", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "5mcg+50mcg;2;Days1-22 (COVOVAX )", "treatment_id": 1158, "treatment_name": "Sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5mcg+50mcg;2;Days1-22 (Novavax)", "treatment_id": 1158, "treatment_name": "Sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]

Nov. 13, 2021, 5:33 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "N/A", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

March 26, 2021, 2:21 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant]: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticlevaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant] is available as aready to use liquid formulation in a vial containing 5 mcg antigen and 50 mcgMatrix-M1 adjuvant. Each dose of 0.5 ml (5 mcg antigen and 50 mcgMatrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.Manufacturer: Serum Institute of India Pvt. Ltd. (SIIPL).Control Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant is available as a ready touse liquid formulation in a vial containing 5 mcg antigen and 50 mcg Matrix-M1 adjuvant. Each dose of 0.5 ml (5 mcg antigen and 50 mcg Matrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.Manufacturer: Novavax; USAControl Intervention2: Placebo: Placebo: 0.9%Normal saline (Sodium chloride) for injection. Each dose of 0.5 ml will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant]: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticlevaccine (SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 adjuvant] is available as aready to use liquid formulation in a vial containing 5 mcg antigen and 50 mcgMatrix-M1 adjuvant. Each dose of 0.5 ml (5 mcg antigen and 50 mcgMatrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.Manufacturer: Serum Institute of India Pvt. Ltd. (SIIPL).Control Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant is available as a ready touse liquid formulation in a vial containing 5 mcg antigen and 50 mcg Matrix-M1 adjuvant. Each dose of 0.5 ml (5 mcg antigen and 50 mcg Matrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.Manufacturer: Novavax; USAControl", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "Control Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine(SARS-CoV-2 rS) with Matrix-M1\u00e2?\u00a2 Adjuvant is available as a ready touse liquid formulation in a vial containing 5 mcg antigen and 50 mcg Matrix-M1 adjuvant. Each dose of 0.5 ml (5 mcg antigen and 50 mcg Matrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.Manufacturer: Novavax; USAControl Intervention2: Placebo: Placebo: 0.9%Normal saline (Sodium chloride) for injection. Each dose of 0.5 ml will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.", "treatment_type": "Placebo", "pharmacological_treatment": "TODO"}]