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 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
920
Senders Pediatrics
South Euclid, Ohio, United States
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
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
Time frame: Within 7 days
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
Time frame: Within 7 days
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
Time frame: Within 7 days
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
Time frame: Within 7 days
Cohort 1: Proportion of participants reporting adverse events (AEs) through 1 month following investigational product administration
Describe AEs in children 5 to \<18 years of age with chronic medical conditions
Time frame: From vaccination through 1 month after vaccination
Cohort 2: Proportion of participants reporting adverse events (AEs) through 1 month following last investigational product administration
Describe AEs in children 5 to \<18 years of age with immunocompromising conditions
Time frame: From vaccination through 1 month after last vaccination
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Cohort 1: Proportion of participants reporting serious adverse events (SAEs) throughout the study
Describe SAEs in children 5 to \<18 years of age with chronic medical conditions
Time frame: From vaccination through 24 months after vaccination
Cohort 2: Proportion of participants reporting serious adverse events (SAEs) throughout the study
Describe SAEs in children 5 to \<18 years of age with immunocompromising conditions
Time frame: From vaccination through 12 months after last vaccination
Cohort 1: Proportion of participants reporting newly diagnosed chronic medical conditions (NDCMCs) throughout the study
Describe NDCMCs in children 5 to \<18 years of age with chronic medical conditions
Time frame: From vaccination through 24 months after vaccination
Cohort 2: Proportion of participants reporting newly diagnosed chronic medical conditions (NDCMCs) throughout the study
Describe NDCMCs in children 5 to \<18 years of age with immunocompromising conditions
Time frame: From vaccination through 12 months after last vaccination
Cohort 1: Geometric mean ratio (GMR), estimated by the ratio of the geometric mean titers (GMTs) for RSV A and RSV B serum neutralizing titers (NTs) 1 month after vaccination in participants in Study C3671017 Cohort 1 compared to those in Study C3671013
Demonstrate that the immune responses elicited by RSVpreF in children 5 to \<18 years of age with chronic medical conditions are noninferior to the immune responses in adults ≥60 years of age
Time frame: 1 month after vaccination
Cohort 1: Seroresponse rate of RSV A and RSV B serum NTs at 1 month after vaccination
Demonstrate that the immune responses elicited by RSVpreF in children 5 to \<18 years of age with chronic medical conditions are noninferior to the immune responses in adults ≥60 years of age. 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
Time frame: 1 month after vaccination
Cohort 2: Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Describe the immune responses elicited by 1 or 2 doses of RSVpreF in children 5 to \<18 years of age with immunocompromising conditions
Time frame: Before each vaccination, 1 month after each vaccination, 12 months after last vaccination
Cohort 2: NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Describe the immune responses elicited by 1 or 2 doses of RSVpreF in children 5 to \<18 years of age with immunocompromising conditions
Time frame: 1 month after each vaccination, 12 months after last vaccination
Cohort 2: NTs for RSV A and RSV B expressed as seroresponse rate
Describe the immune responses elicited by 1 or 2 doses of RSVpreF in children 5 to \<18 years of age with immunocompromising conditions
Time frame: 1 month after each vaccination, 12 months after last vaccination
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
Time frame: Before vaccination, 1 month after vaccination, 12 months after vaccination, 24 months after vaccination
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
Time frame: 1 month after vaccination, 12 months after vaccination, 24 months after vaccination
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
Time frame: 1 month after vaccination, 12 months after vaccination, 24 months after vaccination