P05 Safety, tolerability, and immunogenicity of V114 compared with PCV13 in preterm infants: a pooled subgroup analysis of four Phase III studies

Abstract Background Risk of invasive pneumococcal disease is 3-fold higher in preterm versus full-term infants, mainly due to underlying comorbidities and immunological immaturity. V114 a 15-valent conjugate vaccine (PCV) containing the 13 serotypes 13-valent PCV (PCV13) plus two additional serotypes, 22F 33F. A pooled subgroup analysis was performed infants (<37 weeks gestational age) enrolled 4 paediatric Phase III studies evaluating safety immunogenicity different 4-dose regimens or PCV13. Methods Safety evaluated as proportion participants with AEs following each vaccination. Serotype-specific anti-pneumococcal IgG GMCs, response rates, OPA GMTs were measured at 30 days post-primary series (PPS; post-dose 3 [PD3]), pre-toddler dose, post-toddler dose (PTD; [PD4]). Results 174 180 received PCV13, respectively. Mean age 35.4 (range: 27–37 weeks). Proportions any AE comparable between vaccination groups vaccination; most solicited transient (≤3 days) mild-to-moderate intensity. V114-elicited GMCs (Figure 1), generally PCV13 for shared 33F PPS (PD3) PTD (PD4). Conclusions In has an acceptable profile, well tolerated, induces immune responses Study results support use infants.