Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT |
(MN50) geometric mean titers (GMTs) to the SARS-CoV-2 B.1.351 (Beta) variant at Day 14 (one-dose regimen; Groups C and D) and Day 35 (two-dose regimen; Groups A and B); |
Day 14 and Day 35 |
|
Primary |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs |
Seroconversion rates (SCRs) or seroresponse rates (SRRs) (proportion of participants who achieve = 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 B.1.351 (Beta) variant following their last vaccination. |
Day 14 and Day 35 |
|
Primary |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as GMT |
Neutralizing antibody MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant at Day 14 (one-dose regimen; Group H) and Day 35 (two-dose regimen; Group G); |
Day 14 and Day 35 |
|
Primary |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/SRRs |
SCRs/SRRs (proportion of participants who achieve = 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 Delta variant following their last vaccination. |
Day 14 and Day 35 |
|
Primary |
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) |
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following each vaccination |
Day 0 to Day 7 |
|
Primary |
Incidence, duration, severity, and relationship of unsolicited AEs through 28 days |
Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination |
Day 0 to Day 28 |
|
Primary |
Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) |
Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study. |
Day 0 to Day 217 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated patients |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated patients |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline. |
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in participants seronegative at baseline |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in previously vaccinated participants |
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants |
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline |
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in participants seronegative at baseline |
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in previously vaccinated participants |
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants |
GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline |
GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated participants |
GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline |
GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline |
GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants |
GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in participants seronegative at baseline |
GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline. |
Day 0 to Day 217 |
|
Secondary |
Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in previously vaccinated participants |
GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals |
Day 0 to Day 189 |
|