Skip to content
← Full study record

NCT04847050 · OUTCOME

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.

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.

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.

Analysis denominator · Participants

GroupSource count
Hematologic Low Immunosuppression - Initial Phase2
Hematologic Intermediate Immunosuppression - Initial Phase3
Hematologic High Immunosuppression - Initial Phase7
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3
Other Hematologic Malignancy - Booster Phase4

Reported measurements

Screening or Day 0 visit - Weight
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase4Not reportedNot reportedNot reportedNot reported
Screening or Day 0 visit -Temperature
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase4Not reportedNot reportedNot reportedNot reported
Screening or Day 0 visit - Heart rate/Pulse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase4Not reportedNot reportedNot reportedNot reported
Screening or Day 0 visit - Respirations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase4Not reportedNot reportedNot reportedNot reported
Screening or Day 0 visit - Blood Pressure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase4Not reportedNot reportedNot reportedNot reported
Day 1, visit 1, vaccine dose 1 - Weight
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 1, visit 1, vaccine dose 1 - Temperature
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 1, visit 1, vaccine dose 1 - Respirations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 1, visit 1, vaccine dose 1 - Blood Pressure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase7Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 29, visit 2, vaccine dose 2 - Weight
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 29, visit 2, vaccine dose 2 - Temperature
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase6Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 29, visit 2, vaccine dose 2 - Heart rate/Pulse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase6Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 29, visit 2, vaccine dose 2 - Respirations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase6Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 29, visit 2, vaccine dose 2 - Blood Pressure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase6Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase3Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 209 (6 months), visit 5 (+/- 28 days) - Weight
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 209 (6 months), visit 5 (+/- 28 days) - Temperature
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase1Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 209 (6 months), visit 5 (+/- 28 days) - Heart rate/Pulse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase1Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 209 (6 months), visit 5 (+/- 28 days) - Respirations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase1Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 209 (6 months), visit 5 (+/- 28 days) - Blood Pressure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase1Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase2Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase1Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 394, visit 6 (+/- 28 days) - Weight
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 394, visit 6 (+/- 28 days) - Temperature
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 394, visit 6 (+/- 28 days) - Heart rate/Pulse
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 394, visit 6 (+/- 28 days) - Respirations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase0Not reportedNot reportedNot reportedNot reported
Other Hematologic Malignancy - Booster Phase0Not reportedNot reportedNot reportedNot reported
Day 394, visit 6 (+/- 28 days) - Blood Pressure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Hematologic Low Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic Intermediate Immunosuppression - Initial Phase0Not reportedNot reportedNot reportedNot reported
Hematologic High Immunosuppression - Initial Phase3Not reportedNot reportedNot reportedNot reported
Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial 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
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
    title
    Screening or Day 0 visit - Weight
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
    title
    Screening or Day 0 visit -Temperature
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
    title
    Screening or Day 0 visit - Heart rate/Pulse
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
    title
    Screening or Day 0 visit - Respirations
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
    title
    Screening or Day 0 visit - Blood Pressure
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Day 1, visit 1, vaccine dose 1 - Weight
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Day 1, visit 1, vaccine dose 1 - Temperature
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Day 1, visit 1, vaccine dose 1 - Respirations
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Day 1, visit 1, vaccine dose 1 - Blood Pressure
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Day 29, visit 2, vaccine dose 2 - Weight
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Day 29, visit 2, vaccine dose 2 - Temperature
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      3
    5. 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
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice