Respiratory Syncytial Virus
Conditions
Keywords
Pediatric, mRNA-1345, RSV vaccine, Viral Diseases, Messenger RNA, Moderna
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 (RSV) disease 5 to \<18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3). Part B: The purpose is to provide surveillance for RSV disease for the next RSV season (6 months after re-enrollment) and safety follow-up for Cohort 1 participants that were enrolled and dosed in Part A.
Interventions
BIOLOGICALmRNA-1345
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
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: 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part B: Number of participants With Respiratory syncytial virus-Respiratory tract disease (RSV-RTD), Respiratory syncytial virus- Lower Respiratory tract disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization | Day 1 through EOS (Month 6) |
| Part A: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to 7 days postinjection |
| Part A: Number of Participants with Unsolicited Adverse Events (AEs) | Up to 28 days postinjection |
| Part A: Number of Participants With Medically Attended AEs (MAAEs) | Day 1 through end of study (EOS; Month 6) |
| Part A: Number of Participants With Adverse Events of Special Interest (AESIs) | Day 1 through EOS (Month 6) |
| Part A: Number of Participants With Serious Adverse Events (SAEs) | Day 1 through EOS (Month 6) |
| Part A: Number of Participants With AEs Leading to Discontinuation | Day 1 through EOS (Month 6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody | Day 1, Day 29, and Month 6 | — |
| Part A: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations | Baseline to Day 29 and Month 6 | — |
| Part A: Number of Participants With Seroresponse in RSV Neutralizing Antibody | Baseline to Day 29 and Month 6 | Seroresponse is defined as a postinjection titer \>4-fold-rise if Baseline is \>lower limit of quantification (LLOQ) or \>4 × LLOQ if Baseline titer is \<LLOQ in RSV neutralizing antibody titers at Day 29 and Month 6. |
| Part B: Number of Participants With AESIs | Day 1 through EOS (Month 6) | — |
| Part B: Number of Participants With SAEs | Day 1 through EOS (Month 6) | — |
| Part A: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody | Day 1, Day 29, and Month 6 | — |
Countries
Panama, United States
Outcome results
None listed