mRNA-1273.712
BiologicalIntramuscular (IM) injection.
NCT Number: NCT06634797
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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Notify Me12 year–30 year
All sexes
Interventional
Phase 4
Velocity Clinical Research, Phoenix, Phoenix, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular (IM) injection.
Sodium chloride for IM injection.
Time frame: Day 4 and Day 32
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: Pre-injection 1: Day 1
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
Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females.
Time frame: Day 1 up to Day 57
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.
ModernaTX, Inc.
Industry
A Phase 4, Randomized, Observer-blind, Placebo-controlled, Crossover Study to Assess Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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