A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN CHILDREN AT HIGH RISK OF RSV DISEASE
ROUSSEAU_C3671017
What is the goal of the study?
The study will first enroll immunocompetent, RSV-experienced participants before enrolling immunocompromised participants to allow for safety data review. Both Cohorts 1 (chronic conditions) and 2 (immunocompromising conditions) will be stratified into 2 age strata, 12 to <18 years of age and 5 to><12 years of age to ensure adequate representation of participants across the age range. cohort 1a will enroll participants 12 to><18 years of age with chronic medical conditions and cohort 1b will enroll participants 5 to><12 years of age with chronic medical conditions. cohort 2a will enroll immunocompromised participants 12 to><18 years of age and cohort 2b will enroll immunocompromised participants 5 to><12 years of age. enrollment of immunocompromised participants will commence after approximately 12 months of followup and an internal review of available safety data in immunocompetent participants has been completed.>
Who can participate in the study?
Please contact the study team listed below to learn more.