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NCT04847050 · OUTCOME

Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): 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
7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months

What was measured

Solicited (expected) local and systemic Adverse Reactions (ARs) through 7 days after each injection were assessed using the clinical abnormalities section of the Food and Drug Administration (FDA) -Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Unsolicited (unexpected) adverse events (AEs) through 28 days after each injection and serious adverse events (SAE's) throughout the entire study period were assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

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

GroupSource count
Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase0
Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase0
Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase0
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase2
Post Allogeneic Transplant - Booster Phase1
Other Hematologic Malignancy - Booster Phase10
Other Adult Solid Tumor - Booster Phase0

Reported measurements

Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase1Not reportedNot reportedNot reportedNot reported
Grade 1 Non-serious Solicited - Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase1Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase3Not reportedNot reportedNot reportedNot reported
Grade 1 Non-serious Solicited - Nasal congestion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase1Not reportedNot reportedNot reportedNot reported
Grade 1 Non-serious Solicited - Arthralgia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase1Not reportedNot reportedNot reportedNot reported
Grade 1 Non-serious Solicited - Weight gain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Grade 2 Non-serious Solicited - Conjunctivitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase1Not reportedNot reportedNot reportedNot reported
Grade 2 Non-serious Solicited - Infections and infestations - Other COVID, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase3Not reportedNot reportedNot reportedNot reported
Grade 2 Non-serious Solicited - Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase1Not reportedNot reportedNot reportedNot reported
Grade 2 Non-serious Solicited - Pneumonitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase0Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase1Not reportedNot reportedNot reportedNot reported
Grade 2 Non-serious Solicited - Dental caries
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase1Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Grade 2 Non-serious Solicited - Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Booster Phase1Not reportedNot reportedNot reportedNot reported
Post Allogeneic Transplant - Booster Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        1
    title
    Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage
  2. categories
    1. measurements
      1. group Id
        OG003
        value
        1
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        3
    title
    Grade 1 Non-serious Solicited - Hypertension
  3. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        1
    title
    Grade 1 Non-serious Solicited - Nasal congestion
  4. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        1
    title
    Grade 1 Non-serious Solicited - Arthralgia
  5. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        1
      3. group Id
        OG005
        value
        0
    title
    Grade 1 Non-serious Solicited - Weight gain
  6. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        1
    title
    Grade 2 Non-serious Solicited - Conjunctivitis
  7. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        1
      3. group Id
        OG005
        value
        3
    title
    Grade 2 Non-serious Solicited - Infections and infestations - Other COVID, specify
  8. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        1
    title
    Grade 2 Non-serious Solicited - Neutrophil count decreased
  9. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        1
    title
    Grade 2 Non-serious Solicited - Pneumonitis
  10. categories
    1. measurements
      1. group Id
        OG003
        value
        1
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        0
    title
    Grade 2 Non-serious Solicited - Dental caries
  11. categories
    1. measurements
      1. group Id
        OG003
        value
        1
      2. group Id
        OG004
        value
        0
      3. group Id
        OG005
        value
        0
    title
    Grade 2 Non-serious Solicited - Hypothyroidism
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      0
    units
    Participants
description
Solicited (expected) local and systemic Adverse Reactions (ARs) through 7 days after each injection were assessed using the clinical abnormalities section of the Food and Drug Administration (FDA) -Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Unsolicited (unexpected) adverse events (AEs) through 28 days after each injection and serious adverse events (SAE's) throughout the entire study period were assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. description
    100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection on day (D)1.
    id
    OG004
    title
    Post Allogeneic Transplant - Booster Phase
  6. 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
  7. 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
7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months
title
Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice