The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
1,000
Intramuscular (IM) injection.
Sodium chloride for IM injection.
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.
Time frame: Day 4 and Day 32
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.
Time frame: 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)
Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females.
Time frame: 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.
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Velocity Clinical Research, Phoenix
Phoenix, Arizona, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
Velocity Clinical Research, Banning
San Bernardino, California, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, United States
Velocity Clinical Research, Covington
Covington, Louisiana, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States
...and 14 more locations
Time frame: Day 1 up to Day 57