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
Overview
- Phase
- Phase 4
- Intervention
- mRNA-1273.712
- Conditions
- Healthy Volunteers
- Sponsor
- ModernaTX, Inc.
- Enrollment
- 1000
- Locations
- 24
- Primary Endpoint
- Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Investigator's assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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
- •Has known conditions that may cause elevated cTnI.
- •Cardiac disease/conditions including rhythm disorders and congenital heart disease
- •Uncontrolled hypertension (defined as systolic blood pressure \>140 millimeter of mercury (mmHg) or diastolic blood pressure \>90 mmHg)
- •Alcohol or substance abuse
- •Kidney disease
- •Severe obesity, defined as body mass index (BMI) ≥40 kilograms per square meter (kg/m\^2) (\>20 years) or severe obesity defined as BMI for sex and age ≥120% of the 95th percentile \[BMI ≥35 kg/m\^2\] (for 12 to 20 years)
Arms & Interventions
Sequence 1: mRNA-1273.712 then Placebo
Participants will receive mRNA-1273.712 followed by placebo 28 days later.
Intervention: mRNA-1273.712
Sequence 1: mRNA-1273.712 then Placebo
Participants will receive mRNA-1273.712 followed by placebo 28 days later.
Intervention: Placebo
Sequence 2: Placebo then mRNA-1273.712
Participants will receive placebo followed by mRNA-1273.712 28 days later.
Intervention: mRNA-1273.712
Sequence 2: Placebo then mRNA-1273.712
Participants will receive placebo followed by mRNA-1273.712 28 days later.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
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.
Secondary Outcomes
- Number of Participants With Elevated cTnI Level at Day 1 (Baseline)(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)(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(Day 1 up to Day 57)