Created at Source Raw Value Validated value
June 2, 2022, 8 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 25/05/2022: COHORT A: All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3 ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least 8 weeks after the first; will be one of the following three possibilities: 1. A full standard dose of Pfizer-BioNTech vaccine 2. A third of a standard dose of Pfizer-BioNTech vaccine 3. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) Participants not yet randomised by 29/11/2021 will only be randomised to 1. A full standard dose of Pfizer-BioNTech vaccine 2. A third of a standard dose of Pfizer-BioNTech vaccine All vaccines will be administered intramuscularly according to specific SOPs. Computer-generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1 to the three groups using block randomisation (random block sizes of 3 and 6). Participants not yet randomised by 29/11/2021 will be randomised 1:1 using block randomisation (random sizes of 2 and 4). Follow up is for 10 months. COHORT B: The second part of the study (Cohort B) will investigate various options for a third dose booster in adolescents aged 12 to 15.5 years who have already received two doses of BNT162b2 30 \u00b5g. It will include arms to compare 10 \u00b5g BNT162b2 administered as either paediatric or adult formulation. For direct comparison; the", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "full standard dose", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "booster", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "booster", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]

Jan. 5, 2022, 8:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 08/12/2021: All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following three possibilities: 1. A full standard dose of Pfizer-BioNTech vaccine 2. A third of a standard dose of Pfizer-BioNTech vaccine 3. 4. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) Participants not yet randomised by 29th November 2021 will only be randomised to 1.\tA full standard dose of Pfizer-BioNTech vaccine 2.\tA third of a standard dose of Pfizer-BioNTech vaccine All vaccines will be administered intramuscularly according to specific SOPs. Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1 to the three groups using block randomisation (random block sizes of 3 and 6). Participants not yet randomised by 29th November will be randomised 1:1 using block randomisation (random sizes of 2 and 4). Follow up is for 10 months. Previous intervention as of 19/11/2021: All participants will receive first immunisation with a standard dose of 30 \u00b5g (0.3ml) of Pfizer-BioNTech (BNT162b2) vaccine. This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight w", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "second dose, standard dose;IM;received at least 8 weeks ago a standard dose of Pfizer-BioNTech (BNT162b2) vaccine, dose of 30 \u00b5g (0.3ml)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "second dose, a third of standard dose;IM;received at least 8 weeks ago a standard dose of Pfizer-BioNTech (BNT162b2) vaccine, dose of 30 \u00b5g (0.3ml)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "second heterologous standard dose 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml);IM", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]

Dec. 30, 2021, 7:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 08/12/2021:All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following three possibilities:1. A full standard dose of Pfizer-BioNTech vaccine2. A third of a standard dose of Pfizer-BioNTech vaccine3. 4. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml)Participants not yet randomised by 29th November 2021 will only be randomised to 1.\tA full standard dose of Pfizer-BioNTech vaccine2.\tA third of a standard dose of Pfizer-BioNTech vaccineAll vaccines will be administered intramuscularly according to specific SOPs.Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1 to the three groups using block randomisation (random block sizes of 3 and 6). Participants not yet randomised by 29th November will be randomised 1:1 using block randomisation (random sizes of 2 and 4). Follow up is for 10 months.Previous intervention as of 19/11/2021:All participants will receive first immunisation with a standard dose of 30 \u00b5g (0.3ml) of Pfizer-BioNTech (BNT162b2) vaccine. This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following four possibilities:1. A full standard dose of Pfizer-BioNTec vaccine2. A third of a standard dose of Pfizer-BioNTec vaccine3. A standard dose of Novavax", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Dec. 15, 2021, 3 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 08/12/2021: All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following three possibilities: 1. A full standard dose of Pfizer-BioNTech vaccine 2. A third of a standard dose of Pfizer-BioNTech vaccine 3. 4. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) Participants not yet randomised by 29th November 2021 will only be randomised to 1.\tA full standard dose of Pfizer-BioNTech vaccine 2.\tA third of a standard dose of Pfizer-BioNTech vaccine All vaccines will be administered intramuscularly according to specific SOPs. Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1 to the three groups using block randomisation (random block sizes of 3 and 6). Participants not yet randomised by 29th November will be randomised 1:1 using block randomisation (random sizes of 2 and 4). Follow up is for 10 months. Previous intervention as of 19/11/2021: All participants will receive first immunisation with a standard dose of 30 \u00b5g (0.3ml) of Pfizer-BioNTech (BNT162b2) vaccine. This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight w", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Nov. 26, 2021, 10:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 19/11/2021: All participants will receive first immunisation with a standard dose of 30 \u00b5g (0.3ml) of Pfizer-BioNTech (BNT162b2) vaccine. This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following four possibilities: 1. A full standard dose of Pfizer-BioNTec vaccine 2. A third of a standard dose of Pfizer-BioNTec vaccine 3. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) All vaccines will be administered intramuscularly according to specific SOPs. Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1 to the three groups using block randomisation (random block sizes of 3 and 6). Follow up is for 10 months. Previous intervention as of 27/10/2021: All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml) and 15 \u00b5g (0.15ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following four possibilities: 1. A full standard dose of Pfizer-BioNTec vaccine 2. A third of a standard dose of Pfizer-BioNTec vaccine 3. A half standard dose of Moderna COVID-19 vaccine; dose of 50 \u00b5g (0.25ml) 4. A standard dose of Novavax NV", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Nov. 5, 2021, 2:05 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Current intervention as of 27/10/2021: All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml) and 15 \u00b5g (0.15ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following four possibilities: 1. A full standard dose of Pfizer-BioNTec vaccine 2. A third of a standard dose of Pfizer-BioNTec vaccine 3. A half standard dose of Moderna COVID-19 vaccine; dose of 50 \u00b5g (0.25ml) 4. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) All vaccines will be administered intramuscularly according to specific SOPs. Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1:1 to the four groups using block randomisation (random block sizes of 4 and 8). Follow up is for 12 months. Previous intervention: All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml) and 15 \u00b5g (0.15ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following four possibilities: 1. A full standard dose of Pfizer-BioNTec vaccine 2. A half standard dose of Pfizer-BioNTec vaccine 3. A half standard dose of Mo", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

Sept. 24, 2021, 6 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine; dose of 30 \u00b5g (0.3ml) and 15 \u00b5g (0.15ml). This may either be given in the study; or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine; given at least eight weeks after the first; will be one of the following four possibilities: 1. A full standard dose of Pfizer-BioNTec vaccine 2. A half standard dose of Pfizer-BioNTec vaccine 3. A half standard dose of Moderna COVID-19 vaccine; dose of 50 \u00b5g (0.25ml) 4. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml) All vaccines will be administered intramuscularly according to specific SOPs. Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1:1 to the four groups using block randomisation (random block sizes of 4 and 8). Follow up is for 12 months.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "1. A full standard dose of Pfizer-BioNTec vaccine", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "2. A half standard dose of Pfizer-BioNTec vaccine", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "3. A half standard dose of Moderna COVID-19 vaccine; dose of 50 \u00b5g (0.25ml)", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}, {"arm_notes": "", "treatment_id": null, "treatment_name": "4. A standard dose of Novavax NVXCoV2373; dose of 5 \u00b5g SARS-CoV-2 rS + 50 \u00b5g Matrix-M1 adjuvant (0.5ml)", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]