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The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: mRNA-1273.712 then Placebo | Experimental | Participants will receive mRNA-1273.712 followed by placebo 28 days later. |
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| Sequence 2: Placebo then mRNA-1273.712 | Experimental | Participants will receive placebo followed by mRNA-1273.712 28 days later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273.712 | Biological | Intramuscular (IM) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | Elevated cTnI was defined as >53.53 picograms per milliliter (pg/mL) in males and >38.64 pg/mL in females. One participant who was included in the analysis, had an elevation of cTnI pre-injection of study intervention on Day 1 and had a normal value of cTnI pre-injection of study intervention on Day 29. Note that other factors such as physical activity can affect cTnI. | Day 4 and Day 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females. | Pre-injection 1: Day 1 |
| Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2) |
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Inclusion Criteria:
Exclusion Criteria:
History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
Has known history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
Has a documented history of myocarditis or pericarditis.
Is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) less than 72 hours prior to or at the Screening Visit or Day 1.
Has known conditions that may cause elevated cTnI.
Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator.
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
Reported history of congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV]), immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections disease.
History of Guillain-Barré syndrome.
Receipt of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Velocity Clinical Research, Huntington Park |
Participants were randomized in a 1:1 ratio (500 participants in each injection sequence) to receive 2 study injections (mRNA-1273.712 and placebo) in a crossover design.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: mRNA-1273.712 Then Placebo | Participants received mRNA-1273.712 as an intramuscular (IM) injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study. |
| FG001 | Sequence 2: Placebo Then mRNA-1273.712 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2024 | Jan 16, 2026 |
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| Placebo | Biological | Sodium chloride for IM injection. |
|
Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females. |
| Day 29 and Day 57 |
| Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Adverse Events Leading to Withdrawal | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in birth defects or was an important medical event. A MAAE was defined as an AE that led to an unscheduled visit to a healthcare practitioner. Investigators reported AEs as AESIs based on pre-defined criteria. All suspected cases of cardiomyopathy and non-infectious myocarditis, pericarditis, and myopericarditis were reported as AESIs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' module. | Day 1 up to Day 57 |
| Huntington Park |
| California |
| 90255 |
| United States |
| Velocity Clinical Research, San Diego | La Mesa | California | 91942 | United States |
| Velocity Clinical Research, Banning | San Bernardino | California | 82408 | United States |
| Velocity Clinical Research, Washington DC | Washington D.C. | District of Columbia | 20016 | United States |
| Velocity Clinical Research, Savannah | Savannah | Georgia | 31406 | United States |
| Velocity Clinical Research, Boise | Meridian | Idaho | 83642 | United States |
| Velocity Clinical Research, Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research, Covington | Covington | Louisiana | 70433 | United States |
| Velocity Clinical Research, Lafayette | Lafayette | Louisiana | 70508 | United States |
| Velocity Clinical Research, New Orleans | New Orleans | Louisiana | 70119 | United States |
| Velocity Clinical Research, Gulfport | Gulfport | Mississippi | 39503 | United States |
| Velocity Clinical Research, Grand Island | Grand Island | Nebraska | 68803 | United States |
| Velocity Clinical Research, Lincoln | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | United States |
| Velocity Clinical Research, Albuquerque | Albuquerque | New Mexico | 87107 | United States |
| Velocity Clinical Research, Syracuse | East Syracuse | New York | 13057 | United States |
| Velocity Clinical Research, Durham | Durham | North Carolina | 27701 | United States |
| Velocity Clinical Research, Cleveland | Beachwood | Ohio | 44122 | United States |
| Velocity Clinical Research, Cincinnati, Blue Ash | Blue Ash | Ohio | 45242 | United States |
| Velocity Clinical Research, Cincinnati | Cincinnati | Ohio | 45246 | United States |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | 29621 | United States |
| Velocity Clinical Research, Abilene | Abilene | Texas | 79606 | United States |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | United States |
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study. |
| Received Study Vaccination |
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| COMPLETED |
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| NOT COMPLETED |
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Randomization Set: Included all participants who were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1: mRNA-1273.712 Then Placebo | Participants received mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study. |
| BG001 | Sequence 2: Placebo Then mRNA-1273.712 | Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | Elevated cTnI was defined as >53.53 picograms per milliliter (pg/mL) in males and >38.64 pg/mL in females. One participant who was included in the analysis, had an elevation of cTnI pre-injection of study intervention on Day 1 and had a normal value of cTnI pre-injection of study intervention on Day 29. Note that other factors such as physical activity can affect cTnI. | Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of participants analysed' includes the number of participants with normal cTnI at pre-injection at either Day 1 or Day 29 and non-missing cTnI at both pre-injection and 3 days after any injection. | Posted | Count of Participants | Participants | Day 4 and Day 32 |
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| Secondary | Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females. | Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of participants analysed' includes the number of participants with non-missing cTnI at Day 1. | Posted | Count of Participants | Participants | Pre-injection 1: Day 1 |
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| Secondary | Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2) | Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females. | Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of participants analysed' includes the number of participants with normal cTnI at pre-injection and non-missing cTnI at both pre-injection and 28 days after any injection. | Posted | Count of Participants | Participants | Day 29 and Day 57 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Adverse Events Leading to Withdrawal | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in birth defects or was an important medical event. A MAAE was defined as an AE that led to an unscheduled visit to a healthcare practitioner. Investigators reported AEs as AESIs based on pre-defined criteria. All suspected cases of cardiomyopathy and non-infectious myocarditis, pericarditis, and myopericarditis were reported as AESIs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' module. | Safety Set: All randomized participants who received at least 1 study injection. Data were collected and presented by study intervention sequence, and treatment received. | Posted | Count of Participants | Participants | Day 1 up to Day 57 |
|
Day 1 up to Day 57
Safety Set: All randomized participants who received at least 1 dose of study injection. Data are presented by study intervention sequence, and treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mRNA-1273.712 - Placebo Sequence: mRNA-1273.712 | Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study. | 0 | 500 | 0 | 500 | 0 | 500 |
| EG001 | mRNA-1273.712 - Placebo Sequence: Placebo | Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study. | 0 | 460 | 0 | 460 | 0 | 460 |
| EG002 | Placebo - mRNA-1273.712 Sequence: Placebo | Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study. | 0 | 497 | 0 | 497 | 0 | 497 |
| EG003 | Placebo - mRNA-1273.712: mRNA-1273.712 | Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study. | 0 | 454 | 1 | 454 | 0 | 454 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | ModernaTX, Inc. | 866-663-3762 | WeCareClinicalTrials@modernatx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2025 | Jan 16, 2026 | SAP_001.pdf |
| Preterm newborn infants (gestational age < 37 wks) |
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| Newborns (0-27 days) |
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| Infants and toddlers (28 days-23 months) |
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| Children (2-11 years) |
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| Adolescents (12-17 years) |
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| Adults (18-64 years) |
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| From 65-84 years |
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| 85 years and over |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Multiple |
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| Other |
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| Not Reported |
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Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study. |
| OG002 | Sequence 2 (Placebo - mRNA-1273.712): Placebo | Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study. |
| OG003 | Sequence 2 (Placebo - mRNA-1273.712): mRNA-1273.712 | Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study. |
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