Study period | ||||||
---|---|---|---|---|---|---|
Eligibility | Enrollment, randomization and vaccination | Post-randomization | ||||
Time point | Approximately 12 weeks | Day 0 | Week 4 | Week 12 (± 7 days) | Week 48 (± 7 days) | Continuous follow-up in the frame of the cohort |
Enrollment: | ||||||
Eligibility screena | Xa | |||||
Eligibility assessment | X | |||||
Informed consent | Xa | |||||
Allocation | Xb | |||||
Interventions: | ||||||
Intervention COVID-19 mRNA Vaccine Moderna® | X | X | ||||
Control Comirnaty® (Pfizer/BioNTech vaccine) | X | X | ||||
Assessments: | ||||||
Baseline variables (will be exported from routine cohort data)Baseline blood sample | X | |||||
IgG neutralizing antibodies post randomization but prior to vaccination | X | |||||
Clinical outcomes: | Xe | Xe | ||||
- Immune response IgG neutralizing antibodies | X | xc | ||||
- Newly confirmed asymptomatic SARS-CoV-2 infection | xc | xc,d | xd | |||
-Newly confirmed symptomatic SARS-CoV-2 infection | xc | xc,d | xd | |||
- Severe COVID-19 infection with respiratory failure, evidence of shock, organ failure, admission to ICU, or death | xc | xc,d | xd | |||
- Adverse events from vaccines | xc | |||||
-Serious adverse events | xc,d | xc | xc,d | xd | ||
- PCR confirmed symptomatic infections of household members | xc | xc.d | xd |