NCT04847050 · OUTCOME
Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): 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 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.
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 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.
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 Grade 3 Serious Unsolicited -Immune system disorders - Other, GVHD 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
Grade 3 Serious Unsolicited - Pneumothorax 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 0 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
Grade 1 Non-serious Solicited - Anal hemorrhage 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
Grade 1 Non-serious Solicited - Constipation 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
Grade 1 Non-serious Solicited - Cough 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 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
Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage 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
Grade 1 Non-serious Solicited - 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 1 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 2 Not reported Not reported Not reported Not reported
Grade 1 Non-serious Solicited - Hypoalbuminemia 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
Grade 1 Non-serious Solicited - Hypokalemia 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
Grade 1 Non-serious Solicited - Infections and Infestations - Other, GI Virus 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
Grade 1 Non-serious Solicited - Nasal congestion 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
Grade 1 Non-serious Solicited - White blood cell decreased 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
Grade 1 Non-serious Solicited - Arthralgia 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
Grade 1 Non-serious Solicited - Dyspnea 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
Grade 1 Non-serious Solicited - Weight gain 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 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
Grade 2 Non-serious Solicited - Anorexia 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
Grade 2 Non-serious Solicited - Blurred vision 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
Grade 2 Non-serious Solicited - Conjunctivitis 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
Grade 2 Non-serious Solicited - Creatinine clearance 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
Grade 2 Non-serious Solicited - Dry mouth 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
Grade 2 Non-serious Solicited - Dysgeusia 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
Grade 2 Non-serious Solicited - Hypotension 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
Grade 2 Non-serious Solicited - Immune system disorders - Other, GVHD 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
Grade 2 Non-serious Solicited - Lymphocyte count decreased 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
Grade 2 Non-serious Solicited - Rash maculopapular 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
Grade 2 Non-serious Solicited - Upper respiratory infection 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
Grade 2 Non-serious Solicited - Viremia 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
Grade 2 Non-serious Solicited - Infections and infestations - Other, COVID 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 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
Grade 2 Non-serious Solicited - Neutrophil count decreased 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
Grade 2 Non-serious Solicited - Pneumonitis 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
Grade 2 Non-serious Solicited - Cough 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 0 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
Grade 2 Non-serious Solicited - Dental caries 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 0 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
Grade 2 Non-serious Solicited - Dyspnea 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 0 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
Grade 2 Non-serious Solicited - Hypothyroidism 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 0 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
Grade 2 Non-serious Solicited - Non-cardiac chest pain 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 0 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
Grade 2 Non-serious Solicited - Pneumothorax 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 0 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
Grade 2 Non-serious Solicited - Weight gain 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 0 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
Total Non-serious Solicited 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 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
Total Serious Solicited 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 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
Total Non-serious Unsolicited 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 7 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
Total Serious Unsolicited 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
Complete source fields classes categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 3 Serious Unsolicited -Immune system disorders - Other, GVHD categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 1
title Grade 3 Serious Unsolicited - Pneumothorax categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Anal hemorrhage categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Constipation categories measurements
group Id OG000
value 1
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Cough categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage categories measurements
group Id OG000
value 0
group Id OG001
value 1
group Id OG002
value 2
group Id OG003
value 2
title Grade 1 Non-serious Solicited - Hypertension categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Hypoalbuminemia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Hypokalemia categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Infections and Infestations - Other, GI Virus categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - Nasal congestion categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 1
group Id OG003
value 0
title Grade 1 Non-serious Solicited - White blood cell decreased Show more (12 of 41) 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 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
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 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): Initial Phase
type PRIMARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle