NCT04847050 · OUTCOME

Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase

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: End of 15-minute observation period following each vaccination on Day 1 and Day 29

What was measured

Reactogenicity of mRNA-1273 vaccine was assessed by physical examination findings following vaccination. A physical exam will be performed to assess general physical condition in the following areas: supraclavicular and axillary lymph nodes, cardiovascular, pulmonary, abdomen and skin and include an assessment of pain, tenderness, erythema, induration and warmth at the injection site, fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, and abdominal pain following vaccination.

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.

Hematologic Intermediate Immunosuppression - Initial Phase

Hematologic High Immunosuppression - Initial Phase

Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Hematologic Low Immunosuppression - Initial Phase	2
Hematologic Intermediate Immunosuppression - Initial Phase	3
Hematologic High Immunosuppression - Initial Phase	7
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	3

Reported measurements

Day 1 - Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	6	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	3	Not reported	Not reported	Not reported	Not reported

Day 1 - Tenderness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
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

Day 1 - Erythema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	2	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

Day 1 - Induration and warmth at the injection site

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
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	1	Not reported	Not reported	Not reported	Not reported

Day 1 - Fever

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 1 - Chills

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	1	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

Day 1 - Arthralgia/joint pain

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 1 - Malaise/fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	2	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

Day 1 - Myalgia/body aches

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	2	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

Day 1 - Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	2	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

Day 1 - Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 1 - Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 1 - Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 29 - Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	5	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	3	Not reported	Not reported	Not reported	Not reported

Day 29 - Tenderness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	4	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	1	Not reported	Not reported	Not reported	Not reported

Day 29 - Erythema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	2	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

Day 29 - Induration and warmth at the injection site

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
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	1	Not reported	Not reported	Not reported	Not reported

Day 29 - Fever

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 29 - Chills

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	1	Not reported	Not reported	Not reported	Not reported

Day 29 - Arthralgia/joint pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	0	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

Day 29 - Malaise/fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	5	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	1	Not reported	Not reported	Not reported	Not reported

Day 29 - Myalgia/body aches

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
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	3	Not reported	Not reported	Not reported	Not reported

Day 29 Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	1	Not reported	Not reported	Not reported	Not reported
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	2	Not reported	Not reported	Not reported	Not reported

Day 29 - Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	1	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

Day 29 - Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 29 - Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day 1- Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	Not reported	Not reported	Not reported	Not reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase	Not reported	Not reported	Not reported	Not reported

Day -29 Systolic Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Hematologic Low Immunosuppression - Initial Phase	0	Not reported	Not reported	Not reported	Not reported
Hematologic Intermediate Immunosuppression - Initial Phase	2	Not reported	Not reported	Not reported	Not reported
Hematologic High Immunosuppression - Initial Phase	4	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

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
3
title
Day 1 - Pain
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
0
title
Day 1 - Tenderness
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Day 1 - Erythema
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
1
title
Day 1 - Induration and warmth at the injection site
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Day 1 - Fever
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Day 1 - Chills
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Day 1 - Arthralgia/joint pain
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Day 1 - Malaise/fatigue
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Day 1 - Myalgia/body aches
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Day 1 - Headache
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Day 1 - Nausea
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Day 1 - Vomiting

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
7
group Id
OG003
value
3
units
Participants

description

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.
id
OG001
title
Hematologic Intermediate 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
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

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

End of 15-minute observation period following each vaccination on Day 1 and Day 29

title

Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice