Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

1. Solicited local injection site reactions (pain; tenderness; erythema; swelling); collected via symptom diaries and immunisation eCRFs; within 7 days of administration of each vaccine 2. Solicited systemic and laboratory reactions (pyrexia; fatigue; myalgia; headache; chills; arthralgia) collected via symptom diaries and immunisation eCRFs; within 7 days of administration of each vaccine 3. Unsolicited adverse reactions (ARs; including serious ARs) collected via the eDC system throughout the study period (52 weeks) 4. Serious Adverse Events collected via the eDC system throughout the study period (52 weeks) 5. Unsolicited adverse events collected via the eDC system throughout the study period (52 weeks) 6. The titre of serum neutralising antibodies measured using SARS-CoV-2 pseudovirus-based neutralization assay; data received by statisticians directly from the laboratory; at 2 weeks after the second vaccination 7. The titre of vaccine-induced serum IgG binding antibody responses to the SARS-CoV-2 S glycoprotein; data received by statisticians directly from the laboratory; at 2 weeks after the first and second vaccinations

1. Solicited local injection site reactions (pain; tenderness; erythema; swelling); collected via symptom diaries and immunisation eCRFs; within 7 days of administration of each vaccine 2. Solicited systemic and laboratory reactions (pyrexia; fatigue; myalgia; headache; chills; arthralgia) collected via symptom diaries and immunisation eCRFs; within 7 days of administration of each vaccine 3. Unsolicited adverse reactions (ARs; including serious ARs) collected via the eDC system throughout the study period (52 weeks) 4. Serious Adverse Events collected via the eDC system throughout the study period (52 weeks) 5. Unsolicited adverse events collected via the eDC system throughout the study period (52 weeks) 6. The titre of serum neutralising antibodies measured using SARS-CoV-2 pseudovirus-based neutralization assay; data received by statisticians directly from the laboratory; at 2 weeks after the second vaccination 7. The titre of vaccine-induced serum IgG binding antibody responses to the SARS-CoV-2 S glycoprotein; data received by statisticians directly from the laboratory; at 2 weeks after the first and second vaccinations