Solid Tumor Malignancy, Hematologic Malignancy, Leukemia, Lymphoma, Multiple Myeloma
Conditions
Keywords
mRNA-1273 vaccine, moderna, SARS-CoV-2, booster shot
Brief summary
Background: Coronavirus disease (COVID-19) is a viral infection. It has spread rapidly across the globe. It has overwhelmed health systems. Researchers are concerned that it may undo years of progress in the reduction of cancer-specific death. They want to test a vaccine that might protect people with cancer from COVID-19. Objective: To test the safety and efficacy of a vaccine using messenger ribonucleic acid (mRNA)-1273 that may protect people with cancer from COVID-19. Eligibility: Adults ages 18 and older who have a solid tumor or blood cancer and who may benefit from a vaccine that might prepare their immune system for fighting and preventing infection from COVID-19. Patients with solid tumors must be receiving treatment with an immunotherapy agent. Design: Participants will be screened with a medical history, medicine review, and physical exam. They will have blood tests. They will have a pregnancy test if needed. Participants will get 2 doses of the mRNA-1273 vaccine if they have not been vaccinated already. It will be injected into a muscle in the arm on Days 1 and 29. They will be followed for 12 months after the second dose. Participants will have study visits at the Clinical Center on Days 1, 29, 36,57, 209, and 394. Some visits will last about 4-6 hours. Patients will be able to get up to 3 doses of mRNA-1273 as a booster on trial if they have already completed a primary series of a vaccine. Participants who have already received a booster dose of vaccine will be able to enroll to receive additional boosters. It will be injected into a muscle in the arm on Day 1. Participants will be followed for 12 months after their last booster injection. Participants who receive booster doses will have study visits at the Clinical Center on Days 1, 29, 57, 180 and 360. Participants will give blood and saliva samples for research. Participation will last about 16 months.
Detailed description
Design of the Study: This is an open-label, multicenter clinical trial designed to evaluate the safety, reactogenicity and primary immunogenicity of the messenger ribonucleic acid (mRNA)-1273 vaccine administered in 2 doses, 28 days apart, in participants who have hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a Programmed cell death protein 1 (PD-1)/Programmed death-ligand 1 (PDL-1) inhibitor for treatment of a solid tumor can be associated with appropriately high rates of development of neutralizing antibodies of mRNA-1273. The trial will also evaluate the safety, reactogenicity and immunogenicity after administration of additional booster doses of the vaccine. Study Phase: Study Population: For the vaccine-na(SqrRoot) ve cohorts, up to 80 participants will be enrolled. * 20 participants with solid tumor malignancies who have initiated PD1/PDL1 inhibitor therapy as part of standard of care and are deemed to have a stable regimen without the need for any immunosuppressive therapy or corticosteroids. * 60 participants with leukemia, lymphoma, multiple myeloma and participants post-allogeneic stem cell transplant will be enrolled based on their perceived risk of immunosuppression. For the previously-vaccinated (also known as booster) cohorts, up to 140 participants will be enrolled for booster injections. All participants on the vaccine-na(SqrRoot) ve cohorts will have the option of receiving boosters; however, they will not count towards the maximum accrual goal for each of the booster groups. Note: All participants will be eligible to receive up to three (3) booster doses of vaccine on study. * 20 participants with solid tumor malignancies who have initiated PD1/PDL1 inhibitor therapy as part of standard of care and are deemed to have a stable regimen without the need for any immunosuppressive therapy or corticosteroids. * 20 participants with chronic lymphocytic leukemia who are not currently on any therapies * 20 participants with chronic lymphocytic leukemia who are on Bruton's tyrosine kinase (BTK) inhibitor therapy alone * 30 participants with any chimeric antigen receptor (CAR) T Cell therapy for a hematologic malignancy * 20 participants post-allogeneic stem cell transplant * 20 participants with other hematologic malignancies * Up to 10 participants with any solid tumor who are not otherwise eligible for any of the other cohorts Number of Sites: 2 Description of Study Product or Intervention: mRNA-1273 Injection (Drug Product) is an lipid nanoparticles (LNPs) dispersion containing a single mRNA sequence (Drug Substance) that encodes the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S glycoprotein stabilized in the prefusion conformation. The mRNA-1273 Drug Substance is combined with a mixture of 4 lipids common to the Moderna's mRNA vaccine platform: SM-102 (a custom-manufactured, ionizable lipid) and 3 commercially available lipids, cholesterol, distearoylphosphatidylcholine (DSPC), and 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000-DMG) (https://doi.org/10.1038/s41587-020- 00807-1). mRNA-1273 Injection is provided as a sterile solution for injection, white to off white dispersion in appearance. Presentation: mRNA-1273 Injection is provided as a sterile solution for injection at a concentration of 0.2 mg/mL in 20 mM trometamol (Tris) buffer containing 87 mg/mL sucrose and 4.3 mM acetate, at potential hydrogen (pH) 7.5. mRNA-1273 Injection is presented in 10R USP Type I borosilicate glass vials with PLASCAP vial seal containing a 20 mm FluroTec-coated plug stopper and has a 6.3 mL nominal fill volume. This vial may be used for more than one participant. mRNA-1273 Injection must be stored frozen at -15 degrees C to -25 degrees C until thawed for use and then stored refrigerated at 2 degrees C to 8 degrees C for up to 30 days (once thawed it must not be refrozen) Each dose of 100 mcg (0.5 mL) will be administered via IM injection into the deltoid muscle on Days 1 and 29 (+/- 3 days) for the vaccine-na(SqrRoot) ve cohorts. Up to 3 additional (booster) doses of the vaccine may also be administered. Study Objectives: Primary: * To evaluate the safety and reactogenicity of the mRNA-1273 vaccine administered in 2 doses, 28 days apart, in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment, or receiving a PD-1/PDL-1 inhibitor for treatment of a solid tumor for patients who are vaccine-na(SqrRoot) ve * To evaluate the safety and reactogenicity of booster doses of mRNA-1273 vaccine administered to participants who have previously received an mRNA or alternative vaccine regimen * To evaluate the safety and reactogenicity of booster doses of mRNA-1273 administered to participants with chronic lymphocytic leukemia (CLL) who are either off treatment or are engaging in a 3-week BTK inhibitor interruption to enhance vaccine immunogenicity * To assess the immunogenicity of mRNA-1273 in participants with cancer, as assessed by the titer or level of specific binding antibody (bAb) Secondary: * To evaluate the immunogenicity of the mRNA-1273 vaccine administered in 2 doses 28 days apart, as assessed by the titer or level of neutralizing antibody (nAb) in the vaccine-na(SqrRoot) ve cohorts * To evaluate the immunogenicity of booster doses of mRNA-1273 vaccine administered to participants who have previously been vaccinated against SARS-CoV2 with any prior vaccine regimen. as assessed by the titer or level of neutralizing antibody (nAb) Exploratory: * To assess immune responses against the SARS-CoV-2 nucleocapsid and spike proteins * To evaluate salivary measurement of immunoglobulin G (IgG) antibodies against the SARS-CoV-2 nucleocapsid and spike (S) proteins Duration of Individual Participant Participation: The duration for each individual participation is approximately 14 months (from first contact to last visit). Study Duration: Study duration is anticipated to be 16 months (from start of screening to last Participant/last visit).
Interventions
BIOLOGICALMessenger ribonucleic acid (mRNA)-1273 Vaccine
A rapid response, proprietary messenger RNA (mRNA)-based vaccine platform. 100 mcg administered intramuscular (IM) on Day 1 and 29 for vaccine naive cohorts.
BIOLOGICALMessenger ribonucleic acid (mRNA)-1273 Vaccine Booster
A rapid response, proprietary messenger RNA (mRNA)-based vaccine platform. 100 mcg administered intramuscular (IM) on Day 1 for vaccine booster cohorts. Participants may receive up to 3 booster injections on study.
DIAGNOSTIC_TESTECG
Baseline (-28 days/Day 1); and Day 29 (+/- 3 days).
OTHERAntibiotics
Use of prophylactic antibiotics is recommended according to institutional standards.
OTHERAnti-viral agents
Use of prophylactic antiviral agents is recommended according to institutional standards.
OTHERAnti-fungal agent
Use of prophylactic antifungal agents is recommended according to institutional standards.
OTHERAnti-emetics
Use of prophylactic anti-emetics is recommended according to institutional standards.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: Participants must meet all the inclusion criteria in order to be eligible to participate in the study. Participants must have one of the following: * Histologically or cytologically confirmed solid tumor receiving a standard of care programmed cell death protein 1 (PD1)/Programmed death-ligand 1 (PDL1) inhibitor for treatment of their solid tumor (inclusive of Hodgkin Lymphoma and Primary Mediastinal B-Cell Lymphoma participants receiving PD1/PDL1 inhibitors as standard of care therapy) * Confirmed diagnosis of acute leukemia (myeloid (AML) or lymphoid (ALL) or other acute leukemia; multiple myeloma; Waldenstrom macroglobulinemia * Confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) * Be post allogeneic stem cell transplantation (for any indication) * Be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories * Age \>=18 years. * History of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: * Absolute lymphocyte count-Minimum value of 200 cells per mcL * Absolute neutrophil count-Minimum value of 500 cells per mcL * Platelets-Minimum value of 25,000 cells per mcL * Total bilirubin-Maximum value of 3.0 x upper limit of normal * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine transaminase ALT serum glutamic-pyruvic transaminase (SGPT)-Maximum value of 5.0 x upper limit of normal * Creatinine-Maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) * Creatinine clearance (only necessary for participants with elevated creatinine)-For participants with Chronic Kidney Disease, a calculated Glomerular Filtration Rate minimum will be required as follows: \>30 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal. * Participants with history of human immunodeficiency virus (HIV) may enroll * Participants with history of chronic hepatitis B virus (HBV) must be on suppressive therapy (if indicated) with undetectable viral load. * Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured with an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * A negative urine/serum pregnancy test for females of childbearing potential. The effects of mRNA-1273 Vaccine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. Note: A female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). Effective methods of contraception: * Intrauterine device. * Stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. * Hormonal contraceptive tablets. * Injectable hormonal contraceptives. * Implanted hormonal contraceptives. * Cutaneous contraceptive patches. * Intravaginal hormonal contraceptive rings. At least 1 barrier method. Effective barrier methods for use in this study are: * Male or female condom. * Diaphragm. * Creams or gels that contain a chemical to kill sperm If a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. * Ability to understand and the willingness to sign a written informed consent document. * CLL participants undergoing Bruton tyrosine kinases inhibitors (BTKi) treatment interruption: Must be receiving treatment with a BTKi for 6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.
Exclusion criteria
All participants meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | End of 15-minute observation period following each vaccination on Day 1 and Day 29 | 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. |
| Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | End of 15-minute observation period following each vaccination on Day 1 and Day 29 | Reactogenicity of mRNA-1273 vaccine was assessed by physical examination findings following vaccination. A physical exam will be performed to assess general physical condition in the following areas: supraclavicular and axillary lymph nodes, cardiovascular, pulmonary, abdomen and skin and include an assessment of pain, tenderness, erythema, induration and warmth at the injection site, fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, and abdominal pain following vaccination. |
| Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | 7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months | 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. |
| Number of Participants Who Had Vital Signs Performed Prior to Vaccine | 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) | Vital signs: weight, temperature, heart rate/pulse, respirations, and blood pressure will be performed prior to each vaccine. |
| Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 | Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor - Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394. |
| Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | 7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Neutralizing Antibody Samples - Initial Phase | For Vaccine Naive Arm: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 | Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Immunogenicity of mRNA-1273 vaccine was assessed for Vaccine Naive Arm in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor. Assessment was performed on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 |
| Number of Neutralizing Antibody Samples - Booster Phase | Day 1, Day 29, Day 57, Day 180, and Day 360 | Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Participants would receive one to two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively. Immunogenicity of mRNA-1273 vaccine was assessed for Booster Arm in participants with hematologic malignancy with or without ongoing immune suppression and participants with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors: Day 1, Day 29, Day 57, Day 180, and Day 360. |
| Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 1, Day 29, Day 57, Day 180, and Day 360 | Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants with hematologic malignancy with or without ongoing immune suppression and patients with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors. Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 57, Day 180, and Day 360. Participants received one or two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | From study product administration on Day 1 through 28 days after the last vaccination (through resolution); a median of 19.5 months. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Pre-assignment details
No participants were enrolled in the following groups: Chronic Lymphocytic Leukemia (CLL) Not on Active Therapy - Booster Phase; Chronic Lymphocytic Leukemia(CLL) Receiving Bruton´s Tyrosine Kinase(BTK) Interruption-Booster Phase; Chimeric Antigen Receptor (CAR) T Cell Therapy - Booster Phase; and Other Adult Solid Tumor - Booster Phase. In the initial phase, 15 participants started & 4 started in the booster phase = 19 participants enrolled. Participants who crossed over are noted in the table.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 3 |
| 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 | 7 |
| 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. | 3 |
| Other Hematologic Malignancy - Booster Phase 100 mcg (0.5 mL) messenger ribonucleic acid (mRNA)-1273 injection, intramuscular (IM) on day 1. | 4 |
| Total | 19 |
Baseline characteristics
| Characteristic | Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Other Hematologic Malignancy - Booster Phase | Total | Hematologic Low Immunosuppression - Initial Phase | Hematologic Intermediate Immunosuppression - Initial Phase | Hematologic High Immunosuppression - Initial Phase |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 6 Participants | 0 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 13 Participants | 2 Participants | 1 Participants | 6 Participants |
| Age, Continuous | 59.17 years STANDARD_DEVIATION 9.8 | 62.38 years STANDARD_DEVIATION 13.81 | 56.01 years STANDARD_DEVIATION 13.53 | 50.85 years STANDARD_DEVIATION 10.54 | 62.96 years STANDARD_DEVIATION 7.7 | 49.51 years STANDARD_DEVIATION 16.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 18 Participants | 2 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 7 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 4 Participants | 10 Participants | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 19 participants | 2 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 5 Participants | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 14 Participants | 0 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 | 0 / 7 | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 2 / 2 | 1 / 3 | 6 / 7 | 2 / 3 | 3 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 | 2 / 7 | 1 / 3 | 0 / 4 |
Outcome results
Primary
Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase
Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor - Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394.
Time frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Population: Day 394 Groups 1, 2 and 4 respectively; no participants reached this timepoint to be analyzed because, 1) the follow up was too short for participants and/or participants crossed over to the booster cohort.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 57 | 40.0 Au/mL |
| Hematologic Low Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 209 | 53156.4 Au/mL |
| Hematologic Low Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 29 | 0.3 Au/mL |
| Hematologic Low Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 36 | 0.6 Au/mL |
| Hematologic Low Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 1 | 0 Au/mL |
| Hematologic Intermediate Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 36 | 0 Au/mL |
| Hematologic Intermediate Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 57 | 0.23 Au/mL |
| Hematologic Intermediate Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 29 | 0 Au/mL |
| Hematologic Intermediate Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 1 | 0 Au/mL |
| Hematologic Intermediate Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 209 | 53.7 Au/mL |
| Hematologic High Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 394 | 24665.2 Au/mL |
| Hematologic High Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 1 | 2.1 Au/mL |
| Hematologic High Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 29 | 838.4 Au/mL |
| Hematologic High Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 36 | 10830.2 Au/mL |
| Hematologic High Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 57 | 23084.7 Au/mL |
| Hematologic High Immunosuppression - Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 209 | 26153.9 Au/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 36 | 35863.4 Au/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 29 | 608.3 Au/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 1 | 0 Au/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 209 | 3198.9 Au/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) Titers - 1273 Administered in 2 Doses in the Initial Phase | Day 57 | 27319.8 Au/mL |
Primary
Number of Participants Who Had Vital Signs Performed Prior to Vaccine
Vital signs: weight, temperature, heart rate/pulse, respirations, and blood pressure will be performed prior to each vaccine.
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Weight | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Respirations | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Heart rate/Pulse | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Respirations | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Blood Pressure | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Temperature | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Weight | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Blood Pressure | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Heart rate/Pulse | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Respirations | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Temperature | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Blood Pressure | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Temperature | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Heart rate/Pulse | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Respirations | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit -Temperature | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Respirations | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Blood Pressure | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Temperature | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Blood Pressure | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Weight | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Heart rate/Pulse | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Weight | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Weight | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Weight | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Weight | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Heart rate/Pulse | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Blood Pressure | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Temperature | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Blood Pressure | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Respirations | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Heart rate/Pulse | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Heart rate/Pulse | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Respirations | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Temperature | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Blood Pressure | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Weight | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Weight | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit -Temperature | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Blood Pressure | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Temperature | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Weight | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Respirations | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Respirations | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Heart rate/Pulse | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Respirations | 3 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Temperature | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Blood Pressure | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Weight | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Weight | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit -Temperature | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Heart rate/Pulse | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Respirations | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Blood Pressure | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Weight | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Temperature | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Respirations | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Blood Pressure | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Weight | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Temperature | 6 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Heart rate/Pulse | 6 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Respirations | 6 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Blood Pressure | 6 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Temperature | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Heart rate/Pulse | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Respirations | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Blood Pressure | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Weight | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Temperature | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Heart rate/Pulse | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Respirations | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Blood Pressure | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Blood Pressure | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Blood Pressure | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Heart rate/Pulse | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Weight | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Respirations | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit -Temperature | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Respirations | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Weight | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Temperature | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Temperature | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Respirations | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Heart rate/Pulse | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Respirations | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Heart rate/Pulse | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Temperature | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Heart rate/Pulse | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Blood Pressure | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Weight | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Respirations | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Weight | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Temperature | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Blood Pressure | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Blood Pressure | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Weight | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Blood Pressure | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Blood Pressure | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Weight | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Respirations | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Temperature | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Heart rate/Pulse | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Heart rate/Pulse | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Temperature | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Respirations | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 1, visit 1, vaccine dose 1 - Weight | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Respirations | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 209 (6 months), visit 5 (+/- 28 days) - Blood Pressure | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Blood Pressure | 4 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Weight | 4 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Weight | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Respirations | 4 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Temperature | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit - Heart rate/Pulse | 4 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Blood Pressure | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Heart rate/Pulse | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Temperature | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 394, visit 6 (+/- 28 days) - Heart rate/Pulse | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Respirations | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Day 29, visit 2, vaccine dose 2 - Weight | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants Who Had Vital Signs Performed Prior to Vaccine | Screening or Day 0 visit -Temperature | 4 Participants |
Primary
Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase
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.
Time frame: 7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Weight gain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Dental caries | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other COVID, specify | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Nasal congestion | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Hypertension | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Pneumonitis | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Arthralgia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 1 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Hypertension | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Nasal congestion | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Arthralgia | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Weight gain | 1 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other COVID, specify | 1 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Pneumonitis | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Dental caries | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Dental caries | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Nasal congestion | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Pneumonitis | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Hypertension | 3 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Weight gain | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other COVID, specify | 3 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Booster Phase | Grade 1 Non-serious Solicited - Arthralgia | 1 Participants |
Primary
Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase
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.
Time frame: 7 and 28 days after each injection and throughout the entire study period, a median of 19.5 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other, COVID | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Upper respiratory infection | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Non-cardiac chest pain | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypokalemia | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Lymphocyte count decreased | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumothorax | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Weight gain | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Solicited | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Unsolicited | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Anal hemorrhage | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited -Immune system disorders - Other, GVHD | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited - Pneumothorax | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Constipation | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dry mouth | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Infections and Infestations - Other, GI Virus | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Creatinine clearance | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Cough | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Unsolicited | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Nasal congestion | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumonitis | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - White blood cell decreased | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Cough | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Solicited | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Arthralgia | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Dyspnea | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Weight gain | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Anorexia | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Blurred vision | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dental caries | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dysgeusia | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypertension | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypotension | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dyspnea | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Immune system disorders - Other, GVHD | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Viremia | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Rash maculopapular | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypoalbuminemia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Cough | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Solicited | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Upper respiratory infection | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumonitis | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Anal hemorrhage | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Weight gain | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypotension | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Weight gain | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypokalemia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Immune system disorders - Other, GVHD | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Viremia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumothorax | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Solicited | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypertension | 1 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Unsolicited | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Rash maculopapular | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Non-cardiac chest pain | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited -Immune system disorders - Other, GVHD | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Unsolicited | 1 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Constipation | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited - Pneumothorax | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Blurred vision | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Arthralgia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Infections and Infestations - Other, GI Virus | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Dyspnea | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Anorexia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dental caries | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Creatinine clearance | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Cough | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dry mouth | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Nasal congestion | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other, COVID | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Lymphocyte count decreased | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - White blood cell decreased | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dysgeusia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypoalbuminemia | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dyspnea | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Solicited | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited - Pneumothorax | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Anal hemorrhage | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Constipation | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Cough | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypertension | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypoalbuminemia | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypokalemia | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Infections and Infestations - Other, GI Virus | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - White blood cell decreased | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Arthralgia | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Dyspnea | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Weight gain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Anorexia | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Creatinine clearance | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dysgeusia | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypotension | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Immune system disorders - Other, GVHD | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Lymphocyte count decreased | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Rash maculopapular | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Upper respiratory infection | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Viremia | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Non-cardiac chest pain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumothorax | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Unsolicited | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited -Immune system disorders - Other, GVHD | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Nasal congestion | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Blurred vision | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dry mouth | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dental caries | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other, COVID | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dyspnea | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Weight gain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Solicited | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Unsolicited | 7 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumonitis | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Cough | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dental caries | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Viremia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Immune system disorders - Other, GVHD | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypotension | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dysgeusia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Unsolicited | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Infections and infestations - Other, COVID | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dry mouth | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Creatinine clearance | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypertension | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Cough | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Neutrophil count decreased | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Conjunctivitis | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Hypothyroidism | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Anorexia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Weight gain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Dyspnea | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Constipation | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Weight gain | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Arthralgia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited -Immune system disorders - Other, GVHD | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Solicited | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - White blood cell decreased | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Nasal congestion | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Anal hemorrhage | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Serious Solicited | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Infections and Infestations - Other, GI Virus | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypokalemia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 3 Serious Unsolicited - Pneumothorax | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Total Non-serious Unsolicited | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hypoalbuminemia | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Blurred vision | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 1 Non-serious Solicited - Hemorrhoidal hemorrhage | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Cough | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumonitis | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Pneumothorax | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Non-cardiac chest pain | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Lymphocyte count decreased | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Rash maculopapular | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Dyspnea | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase | Grade 2 Non-serious Solicited - Upper respiratory infection | 0 Participants |
Primary
Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase
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.
Time frame: End of 15-minute observation period following each vaccination on Day 1 and Day 29
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Arthralgia/joint pain | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Tenderness | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Erythema | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Induration and warmth at the injection site | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Fever | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Chills | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Pain | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Malaise/fatigue | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Myalgia/body aches | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Headache | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Nausea | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Vomiting | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Abdominal pain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Pain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Tenderness | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Erythema | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Induration and warmth at the injection site | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Fever | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Chills | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Arthralgia/joint pain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Malaise/fatigue | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Myalgia/body aches | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Headache | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Nausea | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Vomiting | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Abdominal pain | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Myalgia/body aches | 1 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Malaise/fatigue | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Headache | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Nausea | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Vomiting | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Vomiting | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Myalgia/body aches | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Abdominal pain | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Pain | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Tenderness | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Headache | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Erythema | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Induration and warmth at the injection site | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Fever | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Pain | 1 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Tenderness | 1 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Nausea | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Erythema | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Chills | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Induration and warmth at the injection site | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Fever | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Chills | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Arthralgia/joint pain | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Arthralgia/joint pain | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Malaise/fatigue | 0 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Abdominal pain | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Arthralgia/joint pain | 2 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Fever | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Pain | 7 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Headache | 5 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Malaise/fatigue | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Fever | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Nausea | 2 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Nausea | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Tenderness | 3 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Vomiting | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Arthralgia/joint pain | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Chills | 4 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Abdominal pain | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Myalgia/body aches | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Erythema | 2 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Pain | 2 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Vomiting | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Myalgia/body aches | 5 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Tenderness | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Malaise/fatigue | 8 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 1 - Induration and warmth at the injection site | 2 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Erythema | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Headache | 1 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Chills | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Induration and warmth at the injection site | 0 Participants |
| Other Hematologic Malignancy - Booster Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA) -1273 of a Booster Vaccination: Booster Phase | Day 29 - Abdominal pain | 0 Participants |
Primary
Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase
Reactogenicity of mRNA-1273 vaccine was assessed by physical examination findings following vaccination. A physical exam will be performed to assess general physical condition in the following areas: supraclavicular and axillary lymph nodes, cardiovascular, pulmonary, abdomen and skin and include an assessment of pain, tenderness, erythema, induration and warmth at the injection site, fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, and abdominal pain following vaccination.
Time frame: End of 15-minute observation period following each vaccination on Day 1 and Day 29
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Chills | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Chills | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Arthralgia/joint pain | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Fever | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Erythema | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Nausea | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Malaise/fatigue | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Pain | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day -29 Systolic Hypertension | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Abdominal pain | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Myalgia/body aches | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Induration and warmth at the injection site | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1- Hypertension | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 Headache | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Headache | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Tenderness | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Pain | 2 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Induration and warmth at the injection site | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Nausea | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Vomiting | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Fever | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Vomiting | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Arthralgia/joint pain | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Tenderness | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Myalgia/body aches | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Abdominal pain | 0 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Erythema | 1 Participants |
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Malaise/fatigue | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Tenderness | 2 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Pain | 2 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Abdominal pain | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Arthralgia/joint pain | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Erythema | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Chills | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Induration and warmth at the injection site | 1 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Fever | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Erythema | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Vomiting | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Induration and warmth at the injection site | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Tenderness | 1 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Fever | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Nausea | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Chills | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Arthralgia/joint pain | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Malaise/fatigue | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Malaise/fatigue | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1- Hypertension | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 Headache | 1 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Myalgia/body aches | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Headache | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Myalgia/body aches | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Nausea | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Pain | 2 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Vomiting | 0 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day -29 Systolic Hypertension | 2 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Abdominal pain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Tenderness | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Chills | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Tenderness | 4 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Pain | 6 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Erythema | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Induration and warmth at the injection site | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Fever | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Arthralgia/joint pain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Malaise/fatigue | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Myalgia/body aches | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Headache | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Nausea | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Vomiting | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Abdominal pain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Pain | 5 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Erythema | 2 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Induration and warmth at the injection site | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Fever | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Chills | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Arthralgia/joint pain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Malaise/fatigue | 5 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Myalgia/body aches | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 Headache | 3 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Nausea | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Vomiting | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Abdominal pain | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1- Hypertension | 0 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day -29 Systolic Hypertension | 4 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Abdominal pain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Vomiting | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Headache | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day -29 Systolic Hypertension | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Myalgia/body aches | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Myalgia/body aches | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Malaise/fatigue | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Malaise/fatigue | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 Headache | 2 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Arthralgia/joint pain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Fever | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Chills | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Nausea | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Induration and warmth at the injection site | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Erythema | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1- Hypertension | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Vomiting | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Tenderness | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Fever | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Induration and warmth at the injection site | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Erythema | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Pain | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Chills | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Tenderness | 1 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Pain | 3 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Nausea | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 29 - Arthralgia/joint pain | 0 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Reactogenicity of Messenger Ribonucleic Acid (mRNA)-1273 Vaccine: Initial Phase | Day 1 - Abdominal pain | 0 Participants |
Secondary
Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase
Immunogenicity of mRNA 1273 administered in 2 doses was assessed by titer or level of specific binding antibody (bAb), in participants with hematologic malignancy with or without ongoing immune suppression and patients with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors. Titer or level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, Day 29, Day 57, Day 180, and Day 360. Participants received one or two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively.
Time frame: Day 1, Day 29, Day 57, Day 180, and Day 360
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 180 | 18918.0 AU/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 57 | 45003.9 AU/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 1 | 4041.3 AU/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 29 | 30161.9 AU/mL |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 360 | 22329.9 AU/mL |
| Post Allogeneic Transplant - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 57 | 32364.0 AU/mL |
| Post Allogeneic Transplant - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 1 | 23271.4 AU/mL |
| Post Allogeneic Transplant - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 29 | 43021.6 AU/mL |
| Post Allogeneic Transplant - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 180 | 10662.5 AU/mL |
| Post Allogeneic Transplant - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 360 | 2331.7 AU/mL |
| Other Hematologic Malignancy - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 360 | 8555.06 AU/mL |
| Other Hematologic Malignancy - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 180 | 11842.9 AU/mL |
| Other Hematologic Malignancy - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 1 | 4904.71 AU/mL |
| Other Hematologic Malignancy - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 57 | 16527.2 AU/mL |
| Other Hematologic Malignancy - Booster Phase | Immunogenicity of Messenger Ribonucleic Acid (mRNA) -1273 Levels Administered in 2 Doses in the Booster Phase | Day 29 | 22317.0 AU/mL |
Secondary
Number of Neutralizing Antibody Samples - Booster Phase
Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Participants would receive one to two vaccine boosters. Analysis of timepoints after booster 1 and booster 2 are reported collectively. Immunogenicity of mRNA-1273 vaccine was assessed for Booster Arm in participants with hematologic malignancy with or without ongoing immune suppression and participants with solid tumor receiving programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor (PD-L1) inhibitors: Day 1, Day 29, Day 57, Day 180, and Day 360.
Time frame: Day 1, Day 29, Day 57, Day 180, and Day 360
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 180 | 2 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 57 | 3 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 1 | 3 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 29 | 3 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 360 | 1 Samples |
| Post Allogeneic Transplant - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 57 | 1 Samples |
| Post Allogeneic Transplant - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 1 | 1 Samples |
| Post Allogeneic Transplant - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 29 | 2 Samples |
| Post Allogeneic Transplant - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 180 | 1 Samples |
| Post Allogeneic Transplant - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 360 | 1 Samples |
| Other Hematologic Malignancy - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 360 | 9 Samples |
| Other Hematologic Malignancy - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 180 | 10 Samples |
| Other Hematologic Malignancy - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 1 | 10 Samples |
| Other Hematologic Malignancy - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 57 | 10 Samples |
| Other Hematologic Malignancy - Booster Phase | Number of Neutralizing Antibody Samples - Booster Phase | Day 29 | 12 Samples |
Secondary
Number of Neutralizing Antibody Samples - Initial Phase
Number of samples with a neutralizing response (defined as neutralization assay above 30%) will be reported. Immunogenicity of mRNA-1273 vaccine was assessed for Vaccine Naive Arm in participants who have a hematological malignancy and are immunosuppressed due to their disease and/or treatment or receiving a programmed death-1 (PD-1)/programmed death-ligand 1 inhibitor for treatment of a solid tumor. Assessment was performed on Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Time frame: For Vaccine Naive Arm: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Population: Day 394 Groups 1, 2 and 4 respectively; no participants reached this timepoint to be analyzed because, 1) the follow up was too short for participants and/or participants crossed over to the booster cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 29 | 0 Samples |
| Hematologic Low Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 36 | 0 Samples |
| Hematologic Low Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 57 | 0 Samples |
| Hematologic Low Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 1 | 0 Samples |
| Hematologic Low Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 209 | 1 Samples |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 29 | 0 Samples |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 209 | 1 Samples |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 36 | 0 Samples |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 1 | 0 Samples |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 57 | 0 Samples |
| Hematologic High Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 394 | 3 Samples |
| Hematologic High Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 57 | 6 Samples |
| Hematologic High Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 1 | 2 Samples |
| Hematologic High Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 29 | 5 Samples |
| Hematologic High Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 36 | 6 Samples |
| Hematologic High Immunosuppression - Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 209 | 2 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 36 | 3 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 57 | 3 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 1 | 0 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 29 | 3 Samples |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Neutralizing Antibody Samples - Initial Phase | Day 209 | 3 Samples |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: From study product administration on Day 1 through 28 days after the last vaccination (through resolution); a median of 19.5 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hematologic Low Immunosuppression - Initial Phase | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 2 Participants |
| Hematologic Intermediate Immunosuppression - Initial Phase | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 1 Participants |
| Hematologic High Immunosuppression - Initial Phase | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 6 Participants |
| Solid Tumor on Programmed Cell Death protein1/Programmed Cell Death Ligand 1 Inhibitor-Initial Phase | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 2 Participants |
| Post Allogeneic Transplant - Booster Phase | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | 3 Participants |