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.
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
Cystic fibrosis
Medically treated asthma
Other chronic respiratory diseases and malformations of the lung
Applicable to Cohort 1 (a and b) participants only: Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
Applicable to Cohort 1 (a and b) participants only: Individuals with a history of autoimmune disease, past or present, requiring therapeutic intervention including, but not limited to, systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
Parallel
RSVpreF
Biological/VaccineRSVpreF Vaccine
Placebo
Biological/VaccinePlacebo
Cohort 1: Proportion of participants reporting pre-specified local reactions within 7 days following investigational product administration
Describe pre-specified local reactions in children 5 to \<18 years of age with chronic medical conditions
Cohort 2: Proportion of participants reporting pre-specified local reactions within 7 days following each investigational product administration
Describe pre-specified local reactions in children 5 to \<18 years of age with immunocompromising conditions
Cohort 1: Proportion of participants reporting pre-specified systemic events within 7 days following investigational product administration
Describe pre-specified systemic events in children 5 to \<18 years of age with chronic medical conditions
Cohort 2: Proportion of participants reporting pre-specified systemic events within 7 days following each investigational product administration
Describe pre-specified systemic events in children 5 to \<18 years of age with immunocompromising conditions
Cohort 1: NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Describe the immune responses elicited by RSVpreF in children 5 to \<18 years of age with chronic medical conditions
Cohort 1: NTs for RSV A and RSV B expressed as GMFR
Describe the immune responses elicited by RSVpreF in children 5 to \<18 years of age with chronic medical conditions
Cohort 1: NTs for RSV A and RSV B expressed as seroresponse rate
Describe the immune responses elicited by RSVpreF in children 5 to \<18 years of age with chronic medical conditions. Seroresponse is defined as a postvaccination NT ≥4 times the lower limit of quantitation (LLOQ) if the prevaccination titer is below the LLOQ; or a ≥4-fold rise from prevaccination if the prevaccination titer is ≥ LLOQ
This trial is not recruiting at the moment. You can still explore other options:
