Number of Participants Who Had Vital Signs Performed Prior to Vaccine
A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy · Source last updated 2024-08-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Prior to each vaccine. Screening or Day 0 visit; Day 1, visit 1, vaccine dose 1; Day 29, visit 2, vaccine dose 2; Day 209 (6 months), visit 5 (+/- 28 days); and Day 394, visit 6 (+/- 28 days)
What was measured
Vital signs: weight, temperature, heart rate/pulse, respirations, and blood pressure will be performed prior to each vaccine.
Groups in this outcome
Hematologic Low Immunosuppression - Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
Hematologic High Immunosuppression - Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
Other Hematologic Malignancy - Booster Phase
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Hematologic High Immunosuppression - Initial Phase
3
Not reported
Not reported
Not reported
Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase
0
Not reported
Not reported
Not reported
Not reported
Other Hematologic Malignancy - Booster Phase
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
4
title
Screening or Day 0 visit - Weight
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
4
title
Screening or Day 0 visit -Temperature
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
4
title
Screening or Day 0 visit - Heart rate/Pulse
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
4
title
Screening or Day 0 visit - Respirations
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
4
title
Screening or Day 0 visit - Blood Pressure
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
0
title
Day 1, visit 1, vaccine dose 1 - Weight
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
0
title
Day 1, visit 1, vaccine dose 1 - Temperature
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
0
title
Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
0
title
Day 1, visit 1, vaccine dose 1 - Respirations
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
0
title
Day 1, visit 1, vaccine dose 1 - Blood Pressure
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Day 29, visit 2, vaccine dose 2 - Weight
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
6
group Id
OG003
value
3
group Id
OG004
value
0
title
Day 29, visit 2, vaccine dose 2 - Temperature
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
group Id
OG004
value
4
units
Participants
description
Vital signs: weight, temperature, heart rate/pulse, respirations, and blood pressure will be performed prior to each vaccine.
groups
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
id
OG000
title
Hematologic Low Immunosuppression - Initial Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29
id
OG002
title
Hematologic High Immunosuppression - Initial Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on days 1 and 29; with option for subsequent booster dose, 100 mcg (0.5 mL) mRNA-1273 injection (IM) no less than 4 weeks after day 29.
id
OG003
title
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.
id
OG004
title
Other Hematologic Malignancy - Booster Phase
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Prior to each vaccine. Screening or Day 0 visit; Day 1, visit 1, vaccine dose 1; Day 29, visit 2, vaccine dose 2; Day 209 (6 months), visit 5 (+/- 28 days); and Day 394, visit 6 (+/- 28 days)
title
Number of Participants Who Had Vital Signs Performed Prior to Vaccine