Created at Source Raw Value Validated value
Aug. 5, 2021, 3:30 p.m. oms

To assess the safety and tolerability of the PIKA COVID-19 vaccine. Safety will be assessed by monitoring the solicited adverse events (AEs) for example Injection site reactions (pain; swelling; and erythema); fever; fatigue; nausea; headache and myalgia. Solicited adverse events will be recorded by diary card. [Solicited Adverse Events will be recorded on Day 1; Day 8; Day 15 post dose and during early termination if it is terminated before D15. ];Safety assessment will be done by monitoring unsolicited adverse events (AEs). Serious adverse events (SAEs); including suspected and unexpected serious reaction (SUSAR); adverse events of special interest (AESIs); and medically attended adverse events (MAAEs) will be recorded for the entire duration of the study. Unsolicited AEs will be recorded for 7 days and 28 days; respectively; following each vaccine. These will be recorded by the participant in the participant diary and reviewed when the participant attends their visits at the site. [Unsolicited adverse events (AEs) will be recorded on Day 1; Day 8; Day 15; Day 36 post dose and at early termination if it is terminated before D36];Safety will be assessed via clinical laboratory tests including hematology; biochemistry; coagulation[Blood samples will be collected at screening visit; Day 8; Day 15 post dose and at early termination. Should the participant withdraw prior to their Day 15 visit; they will come in for an additional Early Termination visit which includes the collection of samples for haematology; chemistry; coagulation; urinalysis; Neutralizing antibodies; Serum IgG and cellular immunity. Should they withdraw after their Day 15 visit; they will come in for an additional Early Termination visit which will include sample collection for Neutralizing antibodies; Serum IgG and cellular immunity. ]

To assess the safety and tolerability of the PIKA COVID-19 vaccine. Safety will be assessed by monitoring the solicited adverse events (AEs) for example Injection site reactions (pain; swelling; and erythema); fever; fatigue; nausea; headache and myalgia. Solicited adverse events will be recorded by diary card. [Solicited Adverse Events will be recorded on Day 1; Day 8; Day 15 post dose and during early termination if it is terminated before D15. ];Safety assessment will be done by monitoring unsolicited adverse events (AEs). Serious adverse events (SAEs); including suspected and unexpected serious reaction (SUSAR); adverse events of special interest (AESIs); and medically attended adverse events (MAAEs) will be recorded for the entire duration of the study. Unsolicited AEs will be recorded for 7 days and 28 days; respectively; following each vaccine. These will be recorded by the participant in the participant diary and reviewed when the participant attends their visits at the site. [Unsolicited adverse events (AEs) will be recorded on Day 1; Day 8; Day 15; Day 36 post dose and at early termination if it is terminated before D36];Safety will be assessed via clinical laboratory tests including hematology; biochemistry; coagulation[Blood samples will be collected at screening visit; Day 8; Day 15 post dose and at early termination. Should the participant withdraw prior to their Day 15 visit; they will come in for an additional Early Termination visit which includes the collection of samples for haematology; chemistry; coagulation; urinalysis; Neutralizing antibodies; Serum IgG and cellular immunity. Should they withdraw after their Day 15 visit; they will come in for an additional Early Termination visit which will include sample collection for Neutralizing antibodies; Serum IgG and cellular immunity. ]