Primary Outcomes
Description: WHO definition of "influenza-like illness" (ILI) [Fitzner 2018] or confirmed viral/bacterial respiratory infection AND
Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
Measure: The rate of "flu-like illness" which includes:
Time: 1 year
Secondary Outcomes
Measure: The incidence of documented COVID-19 infection (confirmed by any Health Canada approved COVID-19 test. Both symptomatic and asymptomatic infections will be documented
Time: 1 year
Measure: The rate of severe respiratory and COVID-19 infection defined as a confirmed COVID-19 infection leading to hospitalization, ICU admission or death
Time: 1 year
Measure: The number of events that meet the definition of the primary endpoint, as measured within the one-year follow-up (patients may meet the primary endpoint more than once and be counted multiple times).
Time: 1 year
Measure: The incidence of COVID-19 seroconverted patients between baseline, 3 months, 6 months and 12 months
Time: 3, 6, and 12 months
Measure: The incremental cost-effectiveness ratio (in the unit of CAD$ per life-years gained) measured with EQ-5D-5L
Time: 1 year
Measure: Failure-free survival, as time from enrollment to recurrence or progression declared by the investigator on the basis of objective standard evaluation consistent with the disease site or death
Time: 1 year
Measure: Overall survival (OS), as time from enrollment to death from any cause
Time: 1 year
Measure: Incidence, frequency, and severity of AEs considered possibly, probably or definitely related to receipt of IMM-101
Time: 1 year
Measure: Incidence and frequency of local injection site reactions subsequent to IMM-101 administration
Time: 1 year
Measure: Incidence and duration of ICU admission related to documented COVID-19 infection
Time: 1 year