Created at Source Raw Value Validated value
Dec. 10, 2021, 2 p.m. oms

Expected Outcome 1: Frequency (%) of seroconversion 28 days after each dose of vaccine; for each participant group.Seroconversion will be defined by the presence of anti-SARS-CoV-2 antibodies after vaccination in participants with an absence of anti-SARS-CoV-2 antibodies before vaccination and / or at least a 4-fold increase in anti-SARS- antibody titers CoV-2 in participants with anti-SARS-CoV-2 antibodies prior to vaccination.;Expected Outcome 2: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies before and 28 days after each dose of vaccine; for each group of participants;Expected Outcome 3: Frequency (%) of seropositivity at six and twelve months after completing the vaccination for each group of participant. ;Expected Outcome 4: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies six and twelve months after the last vaccine dose for each group of participants;Expected Outcome 5: Frequency (%) of solicited and unsolicited; local and systemic adverse reactions; up to 7 days after each dose of the vaccine; for each group of participants;Expected Outcome 6: frequency (%) of serious adverse events throughout the study period for each group of participants;Expected Outcome 7: frequency (%) of adverse events of special interest (AESI) throughout the study period for each group of participants

Expected Outcome 1: Frequency (%) of seroconversion 28 days after each dose of vaccine; for each participant group.Seroconversion will be defined by the presence of anti-SARS-CoV-2 antibodies after vaccination in participants with an absence of anti-SARS-CoV-2 antibodies before vaccination and / or at least a 4-fold increase in anti-SARS- antibody titers CoV-2 in participants with anti-SARS-CoV-2 antibodies prior to vaccination.;Expected Outcome 2: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies before and 28 days after each dose of vaccine; for each group of participants;Expected Outcome 3: Frequency (%) of seropositivity at six and twelve months after completing the vaccination for each group of participant. ;Expected Outcome 4: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies six and twelve months after the last vaccine dose for each group of participants;Expected Outcome 5: Frequency (%) of solicited and unsolicited; local and systemic adverse reactions; up to 7 days after each dose of the vaccine; for each group of participants;Expected Outcome 6: frequency (%) of serious adverse events throughout the study period for each group of participants;Expected Outcome 7: frequency (%) of adverse events of special interest (AESI) throughout the study period for each group of participants