Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1273 | Experimental | Part A: All participants (healthy participants and SOT participants) who were unvaccinated prior to enrollment will receive 2 intramuscular (IM) injections of 100 microgram (µg) mRNA-1273 on Day 1 and Day 29. All SOT participants who were unvaccinated prior to enrollment will be offered the opportunity to receive a third primary dose of mRNA-1273 at Day 85 as per the emergency use authorization (EUA) Fact Sheet available at the time of protocol finalization. SOT participants who were previously vaccinated with 2 doses of Moderna COVID-19 vaccine under the EUA prior to enrollment will receive Dose 3 on Day 1. Part B: All eligible participants from Part A will be offered to receive a 100 µg booster dose of mRNA-1273 who are at least 4 months from the last dose. SOT recipients who completed primary COVID-19 vaccination series under EUA (outside of the mRNA-1273-P304 study) will receive a 100 µg booster dose on booster dose Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs) | An unsolicited AE was any AE reported by the participant that was not specified as a solicited adverse reaction (AR) or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | Up to 28 days post-vaccination |
| Parts A and B: Number of Healthy Participants With Unsolicited AEs | An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | Up to 28 days post-vaccination |
| Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs) | An MAAE was an AE that led to an unscheduled visit to an healthcare practitioner (HCP). This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 450) |
| Parts A and B: Number of Healthy Participants With MAAEs |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated Participants Receiving the 2-Dose Regimen | The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. |
Not provided
Transplant Recipients
Key Inclusion Criteria for Part A:
Key Exclusion Criteria for Part A:
Healthy Participants
Key Inclusion Criteria for Part A:
Key Exclusion Criteria for Part A:
Inclusion Criteria for Part B:
Exclusion Criteria for Part B:
Exclusion Criteria in Part A will apply except:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventiv Research Inc | Mesa | Arizona | 85206 | United States | ||
| California Institute of Renal Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40248714 | Derived | Girard B, Figueroa AL, De Rosa SC, McElrath MJ, Azzi JR, Stolman D, Siangphoe U, de Windt E, Miller JM, Das R, Priddy F. mRNA-1273 COVID-19 vaccine induces CD4+ T-cell responses among solid organ transplant recipients. Front Immunol. 2025 Apr 3;16:1505871. doi: 10.3389/fimmu.2025.1505871. eCollection 2025. | |
| 38513368 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy participants cohort was included as a control group in the evaluation of humoral and cell-mediated immune response only; no comparisons of safety data with the healthy participants were made.
Data reported for each arm in the Outcome Measures as specified in the Outcome Measure title.
A total of 214 solid organ transplant (SOT) participants (137 SOT kidney and 77 SOT liver participants) and 20 healthy participants were enrolled for the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A (Primary Series): Cohort A1 - SOT Participants | Unvaccinated SOT participants received 2 100-micrograms (μg) doses of mRNA-1273 vaccine by intramuscular (IM) injection, 28 days apart (on Day 1 and Day 29). |
| FG001 | Part A (Primary Series): Cohort A2 - SOT Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A (Primary Series) |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2021 | May 22, 2024 |
Not provided
This is an open-label, single intervention study; there is no randomization
Not provided
Not provided
Not provided
Not provided
An MAAE was an AE that led to an unscheduled visit to an HCP. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. |
| Throughout the study period (up to Day 394) |
| Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs) | An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 450) |
| Parts A and B: Number of Healthy Participants With SAEs | An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 394) |
| Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis | An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 450) |
| Parts A and B: Number of Healthy Participants With AESIs, Including Myocarditis/Pericarditis | An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 394) |
| Parts A and B: Number of SOT Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 450) |
| Parts A and B: Number of Healthy Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 394) |
| Parts A and B: Number of SOT Participants With Adjudicated Biopsy-Proven Organ Rejection | A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 450) |
| Parts A and B: Number of Healthy Participants With Biopsy-Proven Organ Rejection | A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 394) |
| Parts A and B: Number of SOT Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | 7 days post-vaccination |
| Parts A and B: Number of Healthy Participants With Solicited Local and Systemic ARs | Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | 7 days post-vaccination |
| Part A: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2-Specific Neutralizing Antibody (nAb) After the Second Dose in Unvaccinated Participants | The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay (PsVNA) specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 arbitrary units (AU)/milliliter (mL). The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | Day 57 (for unvaccinated participants) |
| Part A: GMC of SARS-CoV-2-Specific nAb 28 Days After Dose 3 | The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. | 28 days after Dose 3 |
| Part B: GMC of SARS-CoV-2-Specific nAb 28 Days After the BD in SOT Participants Who Received the Moderna Primary Series and Non-Moderna Primary Series | The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. | 28 days after BD injection (BD-Day 29) |
| Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen | The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3 |
| Part A: GMFR of nAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| Part A: GMFR of nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3 |
| Part A: Geometric Mean (GM) Value of Anti-SARS-CoV-2 S-specific Binding Antibody (bAb) for Unvaccinated Participants Receiving the 2-Dose Regimen | The GM level of VAC123 spike antibodies, as measured by MesoScale Discovery (MSD) electrochemiluminescence (ECL) multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| Part A: GM Value of Anti-SARS-CoV-2 S-specific bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen | The GM level of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3 |
| Part A: Geometric Mean Fold-Rise (GMFR) of bAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| Part A: GMFR of bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3 |
| Part A: Number of SOT Participants With Asymptomatic SARS-CoV-2 Infection | Asymptomatic SARS-CoV-2 infection was identified by absence of COVID-19 symptoms and infections as detected by reverse transcriptase polymerase chain reaction (RT-PCR) central or local test or serology test as binding antibody (bAb) level against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche Elecsys) at Day 1 that became positive (as measured by Roche Elecsys) post-baseline or positive RT-PCR (CLIA-certified central or local) laboratory post-baseline at scheduled or unscheduled/illness visits. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | 14 days after second and third injection |
| Part A: Number of Healthy Participants With Asymptomatic SARS-CoV-2 Infection | Asymptomatic SARS-CoV-2 infection was identified by absence of COVID-19 symptoms and infections as detected by reverse transcriptase polymerase chain reaction (RT-PCR1) central or local test or serology test as bAb level against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche Elecsys) at Day 1 that became positive (as measured by Roche Elecsys) post-baseline or positive RT-PCR (CLIA-certified central or local) laboratory post-baseline at scheduled or unscheduled/illness visits. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | 14 days after second and third injection |
| Part A: Number of SOT Participants With the Occurrence of COVID-19 | COVID-19 case was identified as a positive post-baseline RT-PCR (CLIA-certified central or local) laboratory for SARS-CoV-2, together with at least 2 systemic symptoms: fever (≥ 38 degree celsius [°C]/≥ 100.4 degree fahrenheit [°F]), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | 14 days after second and third injection |
| Part A: Number of Healthy Participants With the Occurrence of COVID-19 | COVID-19 case was identified as a positive post-baseline RT-PCR (CLIA-certified central or local) laboratory for SARS-CoV-2, together with at least 2 systemic symptoms: fever (≥ 38°C/≥ 100.4°F), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | 14 days after second and third injection |
| Part A: Number of SOT Participants With the Occurrence of Severe COVID-19 | Severe COVID-19 case was identified as a COVID-19 case (RT-PCR [CLIA-certified central or local] laboratory) for SARS-CoV-2, together with any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation(SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeters of mercury (mmHg); or respiratory failure or acute respiratory distress syndrome (ARDS), defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation) or evidence of shock (systolic blood pressure <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; OR admission to an intensive care unit or death. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | 14 days after second and third injection |
| Part A: Number of Healthy Participants With the Occurrence of Severe COVID-19 | Severe COVID-19 case was identified as a COVID-19 case (RT-PCR [CLIA-certified central or local] laboratory) for SARS-CoV-2, together with any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation(SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeters of mercury (mmHg); or respiratory failure or acute respiratory distress syndrome (ARDS), defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation) or evidence of shock (systolic blood pressure <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; OR admission to an intensive care unit or death. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | 14 days after second and third injection |
| Parts A and B: Number of SOT Participants Who Changed Immunosuppressant Therapy | A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | Throughout the study period (up to Day 450) |
| San Diego |
| California |
| 92123 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| Tampa General Medical Group | Tampa | Florida | 33606 | United States |
| Piedmont Transplant Institute | Atlanta | Georgia | 30309 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Colombia University Medical Center | New York | New York | 10032 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Hospital | Cleveland | Ohio | 44195 | United States |
| Hospital of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Figueroa AL, Azzi JR, Eghtesad B, Priddy F, Stolman D, Siangphoe U, Leony Lasso I, de Windt E, Girard B, Zhou H, Miller JM, Das R. Safety and Immunogenicity of the mRNA-1273 Coronavirus Disease 2019 Vaccine in Solid Organ Transplant Recipients. J Infect Dis. 2024 Sep 23;230(3):e591-e600. doi: 10.1093/infdis/jiae140. |
Unvaccinated SOT participants received 3 100-μg doses of mRNA-1273 vaccine by IM injection, on Day 1 and Day 29 (28 days apart) and on Day 85 (56 days after Dose 2). |
| FG002 | Part A (Primary Series): Cohort A3 - SOT Participants | Previously vaccinated SOT participants with 2 doses of Moderna COVID-19 vaccine outside the study received a single 100-μg dose (Dose 3) on Day 1. |
| FG003 | Part A (Primary Series): Cohort A5 - Healthy Participants | Healthy participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). |
| FG004 | Part B (Booster Dose): Cohort B2 - SOT Participants | Unvaccinated SOT participants who received 3 doses of mRNA-1273 vaccine in Part A (Days 1, 29, and 85), received a 100-μg booster dose (BD) of mRNA-1273 vaccine on BD DAY 1. |
| FG005 | Part B (Booster Dose): Cohort B3 - SOT Participants | Previously vaccinated SOT participants with 2 doses of Moderna COVID-19 vaccine outside the study who received a single 100-μg dose (Dose 3) on Day 1 in Part A, received a 100-μg BD of mRNA-1273 vaccine on BD Day 1. |
| FG006 | Part B (Booster Dose): Cohort B4 - SOT Participants | SOT participants who completed primary vaccination with an mRNA or non-mRNA- COVID-19 vaccine outside mRNA-1273-P304, received a 100-μg BD of mRNA-1273 vaccine on BD Day 1. |
| FG007 | Part B (Booster Dose): Cohort B5 - Healthy Participants | Healthy participants who received 2 doses of mRNA-1273 vaccine in Part A (Days 1 and 29), received a 100-μg BD of mRNA-1273 vaccine on BD Day 1. |
| Received First Study Injection |
|
| Received Second Study Injection |
|
| Received Third Study Injection |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B (Booster Dose) |
|
|
Safety set included all participants who received at least 1 dose of study drug in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SOT Kidney Participants | Unvaccinated or previously vaccinated SOT kidney participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
| BG001 | SOT Liver Participants | Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
| BG002 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs) | An unsolicited AE was any AE reported by the participant that was not specified as a solicited adverse reaction (AR) or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Up to 28 days post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With Unsolicited AEs | An unsolicited AE was any AE reported by the participant that was not specified as a solicited AR or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs (that is, for the 7 days after each dose of vaccine). A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Up to 28 days post-vaccination |
|
| |||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs) | An MAAE was an AE that led to an unscheduled visit to an healthcare practitioner (HCP). This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 450) |
| ||||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With MAAEs | An MAAE was an AE that led to an unscheduled visit to an HCP. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory test results follow-up, COVID-19) and visits to HCPs external to the study site (for example, urgent care, primary care physician). MAAEs were also required by protocol for routine surveillance of participants with symptoms for COVID-19 infection (fever, shortness of breath, cough, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea). All confirmed symptomatic COVID-19 cases were recorded as MAAEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 394) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs) | An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 450) |
| ||||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With SAEs | An AE (including an AR) was considered an SAE if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly or birth defect, or medically important event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 394) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis | An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 450) |
| ||||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With AESIs, Including Myocarditis/Pericarditis | An AESI was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 394) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of SOT Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 450) |
| ||||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 394) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of SOT Participants With Adjudicated Biopsy-Proven Organ Rejection | A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 450) |
| ||||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With Biopsy-Proven Organ Rejection | A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 394) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of SOT Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Any study injection solicited safety set included all participants who received any (first, second, third, or booster) study injection and contributed any solicited AR data following that injection. Here, 'Number analyzed' signifies participants evaluable for the specified category. | Posted | Count of Participants | Participants | 7 days post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Parts A and B: Number of Healthy Participants With Solicited Local and Systemic ARs | Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered AEs. The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Any study injection solicited safety set included all participants who received any (first, second, third, or booster) study injection and contributed any solicited AR data following that injection. | Posted | Count of Participants | Participants | 7 days post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Part A: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2-Specific Neutralizing Antibody (nAb) After the Second Dose in Unvaccinated Participants | The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay (PsVNA) specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 arbitrary units (AU)/milliliter (mL). The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | The per protocol (PP) immunogenicity set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline/pre-vaccination, had post-injection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Day 57 (for unvaccinated participants) |
| |||||||||||||||||||||||||||||||||
| Primary | Part A: GMC of SARS-CoV-2-Specific nAb 28 Days After Dose 3 | The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. | The PP immunogenicity set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline/pre-vaccination, had post-injection results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | 28 days after Dose 3 |
| |||||||||||||||||||||||||||||||||
| Primary | Part B: GMC of SARS-CoV-2-Specific nAb 28 Days After the BD in SOT Participants Who Received the Moderna Primary Series and Non-Moderna Primary Series | The GMC of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. | The PP set (Part B) included all participants who received BD of study drug, had no immunologic or virologic evidence of prior COVID-19 at pre-booster before the BD, had post-booster results available for at least 1 assay component corresponding to the immunogenicity analysis objective, and had no major protocol deviations that impacted immune response during the period corresponding to the immunogenicity analysis objective. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | 28 days after BD injection (BD-Day 29) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated Participants Receiving the 2-Dose Regimen | The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: GMC of SARS-CoV-2-Specific nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen | The GMC of VAC62 antibodies, as measured by pseudovirus neutralization assay PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: GMFR of nAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | ratio | 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: GMFR of nAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC62 antibodies, as measured by PsVNA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 10 and ULOQ was 111433 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMC value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | ratio | 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: Geometric Mean (GM) Value of Anti-SARS-CoV-2 S-specific Binding Antibody (bAb) for Unvaccinated Participants Receiving the 2-Dose Regimen | The GM level of VAC123 spike antibodies, as measured by MesoScale Discovery (MSD) electrochemiluminescence (ECL) multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Days 1, 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: GM Value of Anti-SARS-CoV-2 S-specific bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen | The GM level of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | 28 days after Dose 3, 6 months after Dose 3, and 1 year after Dose 3 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: Geometric Mean Fold-Rise (GMFR) of bAb for Unvaccinated Participants Receiving the 2-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. 95% CI cannot be calculated with an 'N' less than 2. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | ratio | 28 days after Dose 1, 28 days after Dose 2, 6 months after Dose 2, and 1 year after Dose 2 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: GMFR of bAb for Unvaccinated and Previously Vaccinated Participants Receiving the 3-Dose Regimen Relative to Day 1 | The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. The GMFR of VAC123 spike antibodies, as measured by MSD ECL multiplex assay specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 69 and ULOQ was 14400000 AU/mL. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. Results in healthy participants were included as reference not for any comparisons. | PP immunogenicity set (Part A): all participants who received at least 1 dose of study drug, had no immunologic/virologic evidence of prior COVID-19 at baseline, had post-injection results available for at least 1 assay component corresponding to immunogenicity analysis, and had no major protocol deviations that impacted immune response. 'Overall number of participants analyzed' = participants analyzed for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | ratio | 28 days after Dose 3, 6 months after Dose 3, 1 year after Dose 3 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of SOT Participants With Asymptomatic SARS-CoV-2 Infection | Asymptomatic SARS-CoV-2 infection was identified by absence of COVID-19 symptoms and infections as detected by reverse transcriptase polymerase chain reaction (RT-PCR) central or local test or serology test as binding antibody (bAb) level against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche Elecsys) at Day 1 that became positive (as measured by Roche Elecsys) post-baseline or positive RT-PCR (CLIA-certified central or local) laboratory post-baseline at scheduled or unscheduled/illness visits. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | The modified intent-to-treat (mITT) set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic or virologic evidence of prior COVID-19 at baseline/pre-vaccination before the first dose of study drug. | Posted | Count of Participants | Participants | 14 days after second and third injection |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of Healthy Participants With Asymptomatic SARS-CoV-2 Infection | Asymptomatic SARS-CoV-2 infection was identified by absence of COVID-19 symptoms and infections as detected by reverse transcriptase polymerase chain reaction (RT-PCR1) central or local test or serology test as bAb level against SARS-CoV-2 nucleocapsid protein negative (as measured by Roche Elecsys) at Day 1 that became positive (as measured by Roche Elecsys) post-baseline or positive RT-PCR (CLIA-certified central or local) laboratory post-baseline at scheduled or unscheduled/illness visits. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | The mITT set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic or virologic evidence of prior COVID-19 at baseline/pre-vaccination before the first dose of study drug. | Posted | Count of Participants | Participants | 14 days after second and third injection |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of SOT Participants With the Occurrence of COVID-19 | COVID-19 case was identified as a positive post-baseline RT-PCR (CLIA-certified central or local) laboratory for SARS-CoV-2, together with at least 2 systemic symptoms: fever (≥ 38 degree celsius [°C]/≥ 100.4 degree fahrenheit [°F]), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | The mITT set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic or virologic evidence of prior COVID-19 at baseline/pre-vaccination before the first dose of study drug. | Posted | Count of Participants | Participants | 14 days after second and third injection |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of Healthy Participants With the Occurrence of COVID-19 | COVID-19 case was identified as a positive post-baseline RT-PCR (CLIA-certified central or local) laboratory for SARS-CoV-2, together with at least 2 systemic symptoms: fever (≥ 38°C/≥ 100.4°F), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s), or at least 1 of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | The mITT set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic or virologic evidence of prior COVID-19 at baseline/pre-vaccination before the first dose of study drug. | Posted | Count of Participants | Participants | 14 days after second and third injection |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of SOT Participants With the Occurrence of Severe COVID-19 | Severe COVID-19 case was identified as a COVID-19 case (RT-PCR [CLIA-certified central or local] laboratory) for SARS-CoV-2, together with any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation(SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeters of mercury (mmHg); or respiratory failure or acute respiratory distress syndrome (ARDS), defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation) or evidence of shock (systolic blood pressure <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; OR admission to an intensive care unit or death. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | The mITT set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic or virologic evidence of prior COVID-19 at baseline/pre-vaccination before the first dose of study drug. | Posted | Count of Participants | Participants | 14 days after second and third injection |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part A: Number of Healthy Participants With the Occurrence of Severe COVID-19 | Severe COVID-19 case was identified as a COVID-19 case (RT-PCR [CLIA-certified central or local] laboratory) for SARS-CoV-2, together with any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation(SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeters of mercury (mmHg); or respiratory failure or acute respiratory distress syndrome (ARDS), defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation) or evidence of shock (systolic blood pressure <90 mm Hg, diastolic BP <60 mm Hg, or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; OR admission to an intensive care unit or death. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | The mITT set (Part A) included all participants who received at least 1 dose of study drug, had no immunologic or virologic evidence of prior COVID-19 at baseline/pre-vaccination before the first dose of study drug. | Posted | Count of Participants | Participants | 14 days after second and third injection |
| ||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Number of SOT Participants Who Changed Immunosuppressant Therapy | A summary of serious adverse events (SAEs) and all nonserious AEs ("Other") reported up to the end of the study (up to Day 419), regardless of causality, is located in the Reported "Adverse Events" section. | Safety set included all participants who received at least 1 dose of study drug in this study. | Posted | Count of Participants | Participants | Throughout the study period (up to Day 450) |
|
All-cause mortality and serious adverse events were collected throughout the entire period of the study (from Day 1 up to the end of study [Day 450]). Unsolicited AEs were collected for 28 days after the vaccination.
The safety analysis population consisted of all randomized participants who received at least 1 dose of vaccine. Unsolicited AEs were evaluated via the electronic case report form (eCRF) by the investigator at each visit. Study participants may have experienced both serious and non-serious event during the study. Thus, the same event in the same participant is summarized in both Serious Adverse Events and Other (Not Including Serious) Adverse Events table.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SOT Kidney Participants | Unvaccinated or previously vaccinated SOT kidney participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. | 4 | 137 | 28 | 137 | 49 | 137 |
| EG001 | SOT Liver Participants | Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. | 0 | 77 | 17 | 77 | 38 | 77 |
| EG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. | 4 | 214 | 45 | 214 | 87 | 214 |
| EG003 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. | 0 | 20 | 1 | 20 | 13 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal wall abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis klebsiella | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis escherichia coli | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Prostate cancer stage ii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Liver transplant rejection | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral artery stenosis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dieulafoy's vascular malformation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulitis meckel's | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium difficile infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Faecalith | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Superficial injury of eye | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
Healthy participants cohort was included as a control group in the evaluation of humoral and cell-mediated immune response only; no comparisons of safety data with the healthy participants were made.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna Clinical Trials Support Center | ModernaTX, Inc. | 1-877-777-7187 | clinicaltrials@modernatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2023 | May 22, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| Other Than Specified |
|
| Withdrawal by Subject |
|
| Death |
|
| Lost to Follow-up |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
|
|
|
Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | SOT Liver Participants | Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A and a single 100-μg BD of mRNA-1273 vaccine in Part B. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 | Part A: SOT Liver (Unvaccinated Participants) | Unvaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A. |
|
|
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
|
|
|
|
| OG001 |
| Part A: SOT Liver (Unvaccinated Participants) |
Unvaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A. |
|
|
| SOT Liver Participants |
Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
|
|
| OG001 | Part A: SOT Liver (Unvaccinated Participants) | Unvaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A. |
|
|
| OG001 |
| SOT Liver Participants |
Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
|
|
| OG001 | Part A: SOT Liver (Unvaccinated Participants) | Unvaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A. |
|
|
| SOT Liver Participants |
Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
|
|
| OG001 | Part A: SOT Liver (Unvaccinated Participants) | Unvaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | Healthy Participants | Healthy participants received 2 doses of mRNA-1273 vaccine in Part A. |
|
|
| OG001 | SOT Liver Participants | Unvaccinated or previously vaccinated SOT liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
| OG002 | SOT Total | Unvaccinated or previously vaccinated SOT kidney and liver participants received up to 3 100-μg doses of mRNA-1273 vaccine in Part A. |
|
|
| OG002 | Part A (Primary Series): Cohort A2 and A3 (SOT Kidney Participants) | Unvaccinated or previously vaccinated SOT kidney participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). Participants also receive a third dose (100-μg) of mRNA-1273 vaccine on Day 85 (56 days after Dose 2). |
| OG003 | Part A (Primary Series): Cohort A2 and A3 (SOT Liver Participants) | Unvaccinated or previously vaccinated SOT liver participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). Participants also receive a third dose (100-μg) of mRNA-1273 vaccine on Day 85 (56 days after Dose 2). |
|
|
|
| OG002 | Part A (Primary Series): Cohort A2 and A3 (SOT Kidney Participants) | Unvaccinated or Previously vaccinated SOT kidney participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). Participants also receive a third dose (100-μg) of mRNA-1273 vaccine on Day 85 (56 days after Dose 2). |
| OG003 | Part A (Primary Series): Cohort A2 and A3 (SOT Liver Participants) | Unvaccinated or previously vaccinated SOT liver participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). Participants also receive a third dose (100-μg) of mRNA-1273 vaccine on Day 85 (56 days after Dose 2). |
|
|
|
|
| Part A (Primary Series): Cohort A1 (SOT Liver Participants) |
Unvaccinated SOT liver participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). |
| OG002 | Part A (Primary Series): Cohort A2 and A3 (SOT Kidney Participants) | Unvaccinated or previously vaccinated SOT kidney participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). Participants also receive a third dose (100-μg) of mRNA-1273 vaccine on Day 85 (56 days after Dose 2). |
| OG003 | Part A (Primary Series): Cohort A2 and A3 (SOT Liver Participants) | Unvaccinated or previously vaccinated SOT liver participants received 2 100-μg doses of mRNA-1273 vaccine by IM injection, 28 days apart (on Day 1 and Day 29). Participants also receive a third dose (100-μg) of mRNA-1273 vaccine on Day 85 (56 days after Dose 2). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|