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NCT04847050 · OUTCOME

Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster 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 of a booster vaccination 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.

Analysis population: No participants were enrolled in Groups CLL, CLL/BTK, CAR-T Cell and Other Adult Solid Tumor Booster Phase. Regarding Other Hematologic Malignancy Booster Phase Group 1 participant crossed over from hematologic low immunosuppression-initial phase; 3 participants crossed over from hematologic intermediate immunosuppression-initial phase; 3 participants crossed over from hematologic high immunosuppression-initial phase; \& 3 participants were initially enrolled (did not cross over) into this group.

Groups in this outcome

Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

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

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Post Allogeneic Transplant - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

Other Hematologic Malignancy - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.

Other Adult Solid Tumor - Booster Phase

100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.

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
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase	0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase	0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase	0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2
Post Allogeneic Transplant - Booster Phase	1
Other Hematologic Malignancy - Booster Phase	10
Other Adult Solid Tumor - Booster Phase	0

Reported measurements

Day 1 - Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	1	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	7	Not reported	Not reported	Not reported	Not reported

Day 1 - Tenderness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	1	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	1	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	3	Not reported	Not reported	Not reported	Not reported

Day 1 - Erythema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	2	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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	2	Not reported	Not reported	Not reported	Not reported

Day 1 - Fever

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	1	Not reported	Not reported	Not reported	Not reported

Day 1 - Chills

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	4	Not reported	Not reported	Not reported	Not reported

Day 1 - Arthralgia/joint pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	1	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	2	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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	1	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	8	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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	1	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	5	Not reported	Not reported	Not reported	Not reported

Day 1 - Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	2	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	5	Not reported	Not reported	Not reported	Not reported

Day 1 - Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	2	Not reported	Not reported	Not reported	Not reported

Day 1 - Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	Not reported	Not reported	Not reported	Not reported

Day 1 - Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	Not reported	Not reported	Not reported	Not reported

Day 29 - Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	2	Not reported	Not reported	Not reported	Not reported

Day 29 - Tenderness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster 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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster 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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	Not reported	Not reported	Not reported	Not reported

Day 29 - Fever

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	Not reported	Not reported	Not reported	Not reported

Day 29 - Chills

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster 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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	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
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	1	Not reported	Not reported	Not reported	Not reported

Day 29 - Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	1	Not reported	Not reported	Not reported	Not reported

Day 29 - Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	Not reported	Not reported	Not reported	Not reported

Day 29 - Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Other Hematologic Malignancy - Booster Phase	0	Not reported	Not reported	Not reported	Not reported

Day 29 - Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase	0	Not reported	Not reported	Not reported	Not reported
Post Allogeneic Transplant - Booster 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
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
7
title
Day 1 - Pain
categories
measurements
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
3
title
Day 1 - Tenderness
categories
measurements
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
2
title
Day 1 - Erythema
categories
measurements
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
2
title
Day 1 - Induration and warmth at the injection site
categories
measurements
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
1
title
Day 1 - Fever
categories
measurements
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
4
title
Day 1 - Chills
categories
measurements
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
2
title
Day 1 - Arthralgia/joint pain
categories
measurements
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
8
title
Day 1 - Malaise/fatigue
categories
measurements
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
5
title
Day 1 - Myalgia/body aches
categories
measurements
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
5
title
Day 1 - Headache
categories
measurements
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
2
title
Day 1 - Nausea
categories
measurements
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Day 1 - Vomiting

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
10
group Id
OG006
value
0
units
Participants

description

Reactogenicity of mRNA-1273 of a booster vaccination 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

description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
id
OG000
title
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
id
OG001
title
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
id
OG002
title
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
id
OG003
title
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
id
OG004
title
Post Allogeneic Transplant - Booster Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1.
id
OG005
title
Other Hematologic Malignancy - Booster Phase
description
100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
id
OG006
title
Other Adult Solid Tumor - Booster Phase

param Type

COUNT_OF_PARTICIPANTS

population Description

No participants were enrolled in Groups CLL, CLL/BTK, CAR-T Cell and Other Adult Solid Tumor Booster Phase. Regarding Other Hematologic Malignancy Booster Phase Group 1 participant crossed over from hematologic low immunosuppression-initial phase; 3 participants crossed over from hematologic intermediate immunosuppression-initial phase; 3 participants crossed over from hematologic high immunosuppression-initial phase; \& 3 participants were initially enrolled (did not cross over) into this group.

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 of a Booster Vaccination: Booster Phase

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice