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
- Conditions
- Respiratory Syncytial Virus
- Registration Number
- NCT06097299
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br>Cohort 1 and Cohort 3:<br><br> - 2 to <5 years of age at Day 1.<br><br> - Healthy, or with stable chronic conditions increasing the risk of RSV disease, per<br> the clinical judgment of the Investigator.<br><br>Cohort 2:<br><br> - 5 to <18 years of age at Day 1.<br><br> - Participants with stable chronic conditions increasing the risk of RSV disease.<br><br> - Female participants of child-bearing potential may be enrolled in the study, if the<br> participant: 1) has a negative urine pregnancy test at Screening and on the day of<br> injection (Day 1); 2) has practiced adequate contraception or has abstained from all<br> activities that could lead to pregnancy for 28 days prior to Day 1; 3) has agreed to<br> continue adequate contraception through 90 days following injection; and 4) is not<br> currently breastfeeding.<br><br>Key Exclusion Criteria (All Cohorts):<br><br> - Acutely ill or febrile (temperature =38.0°Celsius [100.4°Fahrenheit]) within 72<br> hours prior to or at the Screening Visit or Day 1.<br><br> - History of a diagnosis or condition that, in the judgment of the Investigator, may<br> affect study assessment or compromise participant safety.<br><br> - Has received or plans to receive any licensed or authorized vaccine =14 days prior<br> to the study vaccine injection (Day 1) or plans to receive a licensed or authorized<br> vaccine within 14 days after the study vaccine injection.<br><br> - Receipt of any prior systemic immunosuppressants. Short courses (<7 days) of oral<br> corticosteroids are allowed if completed at least 3 months prior to enrollment.<br><br> - Receipt of RSV monoclonal antibodies within 6 months prior to enrollment in the<br> study.<br><br> - Participated in an interventional clinical study within 28 days (6 months for a<br> study assessing a product unlicensed/unauthorized in this age group in country of<br> residence at time of enrollment) prior to the day of enrollment or plans to do so<br> while enrolled in this study.<br><br>Note: Other protocol-defined inclusion and exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants With Medically Attended AEs (MAAEs);Number of Participants With Adverse Events of Special Interest (AESIs);Number of Participants With Serious Adverse Events (SAEs);Number of Participants With AEs Leading to Discontinuation
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody;Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody;Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations;Number of Participants With Seroresponse in RSV Neutralizing Antibody