Created at Source Raw Value Validated value
Jan. 21, 2022, 2 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 10/01/2022: Single-dose annual booster vaccination against ancestral and novel variants of SARS-CoV-2. A computer-generated randomisation list will be prepared by the study statistician. Participants in groups A and C will each be randomised 1:1:1:1 within the 2 cohorts (ChaAdOx1 nCOV-19 and BNT162b2 homologous boost); to the 4 available vaccines in each group using block randomisation. Random block sizes of 4 or 8 will be used. Participants in group B will each be randomised 1:1:1:1:1 within the 2 cohorts (ChaAdOx1 nCOV-19 and BNT162b2 homologous boost); to the 5 available vaccines in each group using block randomisation. Random block sizes of 5 or 10 will be used. The randomisation will be stratified by the study sites and age (<70 and =70 years). Participants; laboratory; and analysing statisticians will remain blind to treatment allocation. ChAdOx1-nCov19: 5x10\u00b9\u00b0 vp (0.5 ml) one IM injection BNT162b2: 30 \u00b5g (0.3 ml) one IM injection mRNA-1273: 0.1 mg (0.5 ml) one IM injection NVX-CoV2373: 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5 ml) one IM injection NVX-CoV2373: 2.5 \u00b5g SARS-CoV-2 rS + 25 \u00b5g Matrix-M1 adjuvant (0.25 ml) one IM injection VLA2001: 33 AU + 0.5 mg Aluminium hydroxide +1mg CPG (0.5 ml) one IM injection VLA2001: 16.5 AU + 0.25 mg Aluminium hydroxide +0.5mg CPG (0.25 ml) one IM injection CVnCoV : 12 \u00b5g (in 0.6 ml) one IM injection BNT162b2: 15mcg (0.15ml) one IM injection Janssen : 5x10\u00b9\u00b0 vp/ml (in 0.5 ml) one IM injection MenACWY: 0.5 ml one IM injection All participants will be followed up from 1", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "5x1010vp (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2.5 \u00b5g SARS-CoV-2 rS + 25 \u00b5g Matrix-M1 adjuvant (0.25ml);1;IM; Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g (0.3ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "33 AU + 0.5mg Aluminium hydroxide +1mg CPG (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 1375, "treatment_name": "Vla2001", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "16.5 AU + 0.25mg Aluminium hydroxide +0.5mg CPG (0.25ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 1375, "treatment_name": "Vla2001", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.1mg (0.5ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "12 \u00b5g (in 0.6ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 364, "treatment_name": "Cvncov", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "15 \u00b5g (0.3ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5x10\u00b9\u2070 vp/ml (in 0.5 ml);1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.5ml;1;IM;Prior ChaAdOx1 nCOV-19 or BNT162b2 homologous boost;Group A,B and C (located to different sites)", "treatment_id": 780, "treatment_name": "Menacwy vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]

June 12, 2021, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current interventions as of 03/06/2021: Single-dose annual booster vaccination against ancestral and novel variants of SARS-CoV-2. A computer-generated randomisation list will be prepared by the study statistician. Participants in groups A and C will each be randomised 1:1:1:1 within the 2 cohorts (ChaAdOx1 nCOV-19 and BNT162b2 homologous boost); to the 4 available vaccines in each group using block randomisation. Random block sizes of 4 or 8 will be used. Participants in group B will each be randomised 1:1:1:1:1 within the 2 cohorts (ChaAdOx1 nCOV-19 and BNT162b2 homologous boost); to the 5 available vaccines in each group using block randomisation. Random block sizes of 5 or 10 will be used. The randomisation will be stratified by the study sites and age (<70 and =70 years). Participants; laboratory; and analysing statisticians will remain blind to treatment allocation. ChAdOx1-nCov19: 5x10\u00b9\u00b0 vp (0.5 ml) one IM injection BNT162b2: 30 \u00b5g (0.3 ml) one IM injection mRNA-1273: 0.1 mg (0.5 ml) one IM injection NVX-CoV2373: 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5 ml) one IM injection NVX-CoV2373: 2.5 \u00b5g SARS-CoV-2 rS + 25 \u00b5g Matrix-M1 adjuvant (0.25 ml) one IM injection VLA2001: 33 AU + 0.5 mg Aluminium hydroxide +1mg CPG (0.5 ml) one IM injection VLA2001: 16.5 AU + 0.25 mg Aluminium hydroxide +0.5mg CPG (0.25 ml) one IM injection CVnCoV : 12 \u00b5g (in 0.6 ml) one IM injection CVnCoV : 6 \u00b5g (in 0.3 ml) one IM injection Janssen : 5x10\u00b9\u00b0 vp/ml (in 0.5 ml) one IM injection MenACWY: 0.5 ml one IM injection All participants will be followed up from", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

May 20, 2021, 7:59 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Single dose annual booster vaccination against ancestral and novel variants of SARS-CoV-2. A computer generated randomisation list will be prepared by the study statistician. Participants in groups A-C will each be randomised 1:1:1:1 within the 2 cohorts (ChaAdOx1 nCOV-19 and BNT162b2 homologous boost); to the 4 available vaccines in each group using block randomisation. Random block sizes of 4 or 8 will be used. The randomisation will be stratified by the study sites and JCVI priority groups (1 and 2).Participants; laboratory and analysing statisticians will remain blind to treatment allocation. ChAdOx1-nCov19: 5x1010vp (0.5ml) one IM injection BNT162b2: 30 \u00b5g (0.3ml) one IM injection mRNA-1273: 0.1mg (0.5ml) one IM injection NVX-CoV2373: 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) one IM injection NVX-CoV2373: 2.5 \u00b5g SARS-CoV-2 rS + 25 \u00b5g Matrix-M1 adjuvant (0.25ml) one IM injection VLA2001: 33 AU + 0.5mg Aluminium hydroxide +1mg CPG (0.5ml) one IM injection VLA2001: 16.5 AU + 0.25mg Aluminium hydroxide +0.5mg CPG (0.25ml) one IM injection CVnCoV : 12 \u00b5g (in 0.6ml) one IM injection CVnCoV : 6 \u00b5g (in 0.3ml) one IM injection MenACWY: 0.5ml one IM injection All participants will be followed up from 12 months post vaccination.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]