Clareo Health | A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ModernaTX, Inc.
Age
2–17
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Part A Cohort 1:
2 to \<5 years of age at Day 1.
Healthy, or with stable chronic conditions increasing the risk of RSV disease, per the clinical judgment of the Investigator.
Cohort 2:
5 to \<18 years of age at Day 1.
Participants with stable chronic conditions increasing the risk of RSV disease.
Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of injection (Day 1); 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to Day 1; 3) has agreed to continue adequate contraception through 90 days following injection; and 4) is not currently breastfeeding.
Part B: Cohort 1 Re-enrollment
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Enrolled and dosed in Part A of Cohort 1; either reached EoS for Part A or were dosed and subsequently discontinued from study for various reasons. This includes participants who were lost to follow-up, if they can be re-engaged.
2. Participant's parent(s)/LAR(s) has provided written informed consent for participation in this study.
You may not be if
Acutely ill or febrile (temperature ≥38.0°Celsius \[100.4°Fahrenheit\]) within 72 hours prior to or at the Screening Visit or Day 1.
History of a diagnosis or condition that, in the judgment of the Investigator, may affect study assessment or compromise participant safety.
Has received or plans to receive any licensed or authorized vaccine ≤14 days prior to the study vaccine injection (Day 1) or plans to receive a licensed or authorized vaccine within 14 days after the study vaccine injection.
Receipt of any prior systemic immunosuppressants. Short courses (\<7 days) of oral corticosteroids are allowed if completed at least 3 months prior to enrollment.
Receipt of RSV monoclonal antibodies within 6 months prior to enrollment in the study.
Participated in an interventional clinical study within 28 days (6 months for a study assessing a product unlicensed/unauthorized in this age group in country of residence at time of enrollment) prior to the day of enrollment or plans to do so while enrolled in this study.
Part B: Cohort 1 Re-enrollment
1\. Participant is currently enrolled in another interventional clinical study.
