Created at Source Raw Value Validated value
Feb. 11, 2022, 8 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Investigational ProductRecombinant covid-19 vaccine (ChAdOx1 nCoV-19) Fiocruz/AstraZenecaDose: 0.5 mL; containing 5 \u00d7 1010 viral particlesVia: Intramuscular (deltoid)Covid-19 Pfizer/Wyeth Vaccine (ComirnatyTM)Dose: 0.3ml; containing 30mcg mRNAVia: Intramuscular (deltoid)Janssen recombinant covid-19 vaccineDose: 0.5mlRoute: intramuscular (deltoid)The volunteers will be grouped into three cohorts; (Cohorts 1; 2 and 3) according to the vaccines received in the primary two-dose vaccine schedule offered in the vaccination campaigns against COVID-19. The cohorts will then be divided into two groups; each receiving a booster dose with different vaccines; which may be a homologous or heterologous booster.Cohort 1: Primary shedule with two doses of Coronavac/ButantanIntervention (booster vaccine):Group 1.1 - Pfizer vaccineGroup 1.2 - Fiocruz/AstraZeneca VaccineGroup 1.3 - Janssen VaccineCohort 2: Primary schedule with two doses of Fiocruz/AstraZenecaIntervention (booster vaccine):Group 2.1 - Pfizer vaccineGroup 2.2 - Fiocruz/AstraZeneca VaccineGroup 2.3 - Janssen VaccineCohort 3: Primary shedule with two doses of Pfizer vaccineIntervention (booster vaccine):Group 3.1 - Pfizer VaccineGroup 3.2 - Fiocruz/AstraZeneca VaccineGroup 3.3 - Janssen VaccineThe number of participants in each of the cohorts is 3000. Totaling 9000 volunteers.For the immunogenicity sub-study; 400 volunteers will be selected in each intervention group.Visit 1Inclusion and exclusion criteria; informed consent; randomization; clinical history; epidemiological data; vaccination. Blood collection for serology in volunteers included in the immunogenicity substudy.Visit 2As;D014614;D022223;D015164", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "5 \u00d7 10^10/0.5mL;1;IM;prior received Coronavac", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30mcg/0.3mL;1;IM;prior received Coronavac", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5 \u00d7 10^10/0.5mL;1;IM;prior received Chadox1 ncov-19", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30mcg/0.3mL;1;IM;prior received Chadox1 ncov-19", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5 \u00d7 10^10/0.5mL;1;IM;prior received Bnt162b2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30mcg/0.3mL;1;IM;prior received Bnt162b2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]

Jan. 13, 2022, 11 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Investigational ProductRecombinant covid-19 vaccine (ChAdOx1 nCoV-19) Fiocruz/AstraZenecaDose: 0.5 mL; containing 5 \u00d7 1010 viral particlesVia: Intramuscular (deltoid)Covid-19 Pfizer/Wyeth Vaccine (ComirnatyTM)Dose: 0.3ml; containing 30mcg mRNAVia: Intramuscular (deltoid)The volunteers will be grouped into three cohorts; (Cohorts 1; 2 and 3) according to the vaccines received in the primary two-dose vaccine schedule offered in the vaccination campaigns against COVID-19. The cohorts will then be divided into two groups; each receiving a booster dose with different vaccines; which may be a homologous or heterologous booster.Cohort 1: Primary shedule with two doses of Coronavac/ButantanIntervention (booster vaccine):Group 1.1 - Pfizer vaccineGroup 1.2 - Fiocruz/AstraZeneca VaccineCohort 2: Primary schedule with two doses of Fiocruz/AstraZenecaIntervention (booster vaccine):Group 2.1 - Pfizer vaccineGroup 2.2 - Fiocruz/AstraZeneca VaccineCohort 3: Primary shedule with two doses of Pfizer vaccineIntervention (booster vaccine):Group 3.1 - Pfizer VaccineGroup 3.2 - Fiocruz/AstraZeneca VaccineThe number of participants in each of the cohorts is 3000. Totaling 9000 volunteers.For the immunogenicity substudy; 500 volunteers will be selected from each of the six study groups.Visit 1Inclusion and exclusion criteria; informed consent; randomization; clinical history; epidemiological data; vaccination. Blood collection for serology in volunteers included in the immunogenicity substudy.Visit 2Assessment of solicited and unsolicited adverse events; with participant diary review. Blood collection for serology in volunteers included in the immunogenicity substudy.Visit 3;D014614;D022223;D015164", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]