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

Moderna

Status and phase: Active, not recruiting; Phase 2

Conditions: Respiratory Syncytial Virus

Treatments: Biological: Placebo; Biological: mRNA-1345

Study type: Interventional

Funder types: Industry

Identifiers

NCT06097299

2023-506271-96-00 (Other Identifier)

mRNA-1345-P202

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups

Part A and Part B: Cohort 1 (2 to <5 Years of Age)

Experimental group

Description:

Part A: Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period.

Treatment:

Biological: mRNA-1345

Biological: Placebo

Part A: Cohort 2 (5 to <18 Years of Age)

Experimental group

Description:

Participants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1.

Treatment:

Biological: mRNA-1345