The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age who are at high risk of RSV disease.
Phase 1 will identify the dose level to be used in Phase 2/3. In this phase, all participants will receive one injection of RSVpreF. Phase 1 has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This phase is about 6 months long for each participant and will be conducted in the United States.
Phase 2/3 will evaluate the selected dose level from Phase 1 in a large number of children to collect more information about the safety of the vaccine and the amount of antibodies produced by the vaccine. In this Phase, all participants will receive either RSVpreF or placebo and will not know which they have received until the end of study. Phase 2/3 will have three scheduled in-clinic visits. Blood samples will be collected for testing. This phase is about 6 months long for each participant.
Closest Location
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
RESPIRATORY SYNCYTIAL VIRUS (RSV)
Sex
Male or Female
Age
2 - 17 years