Created at Source Raw Value Validated value
March 29, 2022, 12:06 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Study Arms: mRNA-1273 (Moderna COVID-19 Vaccine; Spikevax\u00ae) 50 \u00b5g (mRNA) mRNA-1273.529 (Moderna Omicron Variant Vaccine) 50 \u00b5g (mRNA) All participants will have previously received 2 or 3 doses of an authorized/approved COVID-19 vaccine. Participants who had previously received 2 doses of a COVID-19 vaccine as a primary series will receive mRNA-1273.529 or mRNA-1273 as the third dose; and participants who have previously received a primary series and 1 booster dose will receive mRNA-1273.529 or mRNA-1273 as the 4th dose. Participants who will receive the 4th dose as part of the study must have previously received a mRNA vaccine as the 3rd dose of a COVID-19 vaccine. Participants who will receive the 3rd dose as part of the study may have previously received 2 doses of a mRNA or a non-mRNA COVID-19 vaccine. Study visits: will consist of a Screening Visit (up to 28 days before the Day 1 visit); Vaccination Visit at Day 1 and subsequent study visits on Day 8 (for a subset of participants); Day 29 (Month 1); Day 85 (Month 3); Day 179 (Month 6); and Day 359 (Month 12); with up to 13 months of study participation. Unscheduled visits for potential symptoms of COVID-19 will include PCR testing. Randomisation: Randomization will be performed using an interactive response technology (IRT). Approximately 2;924 participants will be randomized in a 1:1 ratio to receive a single dose of either 50 \u00b5g of mRNA-1273.529 or 50 \u00b5g of mRNA-1273 (active control). Randomization will be stratified by age groups (16 to <65 years or =65 years) and number of booster doses received (to receive study vaccine as the 4th dose or to receive study vaccine as the 3rd dose). At least =90% o", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2176, "treatment_name": "Mrna-1273.529", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]