Pfizer
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to \<18 years of age at high risk for RSV disease, including those who are immunocompromised.
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. 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 yea…
Key Inclusion Criteria: * Participants' age requirements for each study cohort at enrollment, respectively Cohort 1a (chronic medical conditions) 12 to \<18 years of age Cohort 1b (chronic medical conditions) 5 to \<12 years of age Cohort 2a (immunocompromising conditions) 12 to \<18 years of age Cohort 2b (immunocompromising conditions) 5 to \<12 years of age * Participants depending on the study cohort requirements, will be considered by the investigator to be at high risk of LRTI-RSV based on the following disease characteristics and definitions: Chronic medical conditions: * Cystic fibr…
RSVpreF Vaccine
Placebo
Arctuva estimate
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