Created at Source Raw Value Validated value
Oct. 21, 2021, 10 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "There are four study cohorts: cohorts 1 and 2 will be the main study cohorts and 3 and 4 will be the sub-study cohorts Participants in cohorts 2; 3 and 4 can receive the Tdap vaccination from the study team during study visits according to routine recommendations in the UK. Screening + study visit 1 (maternal): This visit will take place between 13+0 \u2013 27+6 gestational weeks (for the earlier gestational weeks group) or between 28+0 \u2013 34+0 gestational weeks (for the later gestational weeks group) at the participating institution. Eligibility will be confirmed; the study will be discussed in more detail and women will be asked to sign a consent form. They will then be asked about demographic details (including NHS number); past medical history; receipt of any prior dose of a COVID-19 vaccine; details of the current pregnancy including the results of antenatal screening and scans to ensure that they are eligible for the study. The participant\u2019s antenatal medical notes will be reviewed. Details will be collected about concomitant medication. A physical examination will be performed; and vital signs; height and weight will be recorded. Immunogenicity blood samples will be obtained. Cohort 1; 2; 3: Participants will be randomised to a single group to receive one type of COVID-19 vaccine with the first dose to be given at visit 1. Cohort 4: Participants will receive the same vaccine as given pre-pregnancy or in the first trimester of pregnancy and randomised to either receiving the booster dose before or after 26 weeks gestation. Vaccination will be given by members of the study team who are trained and experienced in vaccine administration and in", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "Pregnant women;Cohort 1;2;Day 1+ one short boost 28 to 42 days", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 1;2;Day 1+ dTAP 28-42 days+ one long boost covid vaccine days 56 to 84\n", "treatment_id": 2342, "treatment_name": "Covid19 vaccine+diphtheria tetanus pertussis vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Pregnant women;Cohort 1;2;Day 1+ one long boost 56-84 days\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 2;2;Day 1+ one short boost 28 to 42 days\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 2;2;Day 1+ one short boost 28 to 42 days + dTAP days 56 to 84\n", "treatment_id": 2342, "treatment_name": "Covid19 vaccine+diphtheria tetanus pertussis vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Pregnant women;Cohort 2;2;Day 1+ one long boost days 56 to 84\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 3;2;Day 1+ one boost 28-34 gestional weeks\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 4 (Participants will receive the same vaccine as given pre-pregnancy or in the first trimester of pregnancy);2;Day 1 + one boost \u2264 26 weeks gestation\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Pregnant women;Cohort 4 (Participants will receive the same vaccine as given pre-pregnancy or in the first trimester of pregnancy);2;Day 1 + one boost > 26 weeks gestation\n", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]