Status:
COMPLETED
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
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Respiratory Syncytial Virus
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to \<5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (R...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- 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:
- 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.
- Participant's parent(s)/LAR(s) has provided written informed consent for participation in this study.
- Key Exclusion Criteria (All Cohorts):
- 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.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2025
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT06097299
Start Date
October 24 2023
End Date
June 27 2025
Last Update
July 10 2025
Active Locations (50)
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1
Velocity Clinical Research, Phoenix
Phoenix, Arizona, United States, 85006
2
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
3
Velocity Clinical Research - Banning
Banning, California, United States, 92220
4
ASCADA Research, LLC - Family Medicine
Fullerton, California, United States, 92835