PMID- 37309607 OWN - NLM STAT- MEDLINE DCOM- 20230703 LR - 20231116 IS - 1098-4275 (Electronic) IS - 0031-4005 (Linking) VI - 152 IP - 1 DP - 2023 Jul 1 TI - Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. LID - e2022060428 [pii] LID - 10.1542/peds.2022-060428 [doi] AB - BACKGROUND AND OBJECTIVES: Disease caused by Streptococcus pneumoniae is associated with considerable morbidity and mortality in children. Pneumococcal conjugate vaccines (PCVs) are well tolerated and effective at reducing pneumococcal disease caused by vaccine serotypes. VAXNEUVANCE (V114) is a 15-valent PCV containing 13 serotypes in Prevnar 13 (PCV13), plus serotypes 22F and 33F. This large phase 3 study evaluated safety and tolerability of V114 in infants. METHODS: In total, 2409 infants were randomized to receive V114 or PCV13 at 2, 4, 6, and 12 to 15 months of age. Safety was evaluated as the proportion of participants with adverse events (AEs). Solicited and unsolicited injection-site and systemic AEs were collected for 14 days after each study vaccination, and serious AEs up to 6 months after the last PCV dose. RESULTS: The proportions of participants with injection-site, systemic, vaccine-related, and serious AEs were generally comparable between recipients of V114 and PCV13. The most frequently reported AEs were solicited, with irritability and somnolence being the most frequent in both groups. Although the incidence of some AEs was higher in the V114 group, the between-group differences were small. The majority of experienced AEs were of mild-to-moderate intensity and lasted