PMID- 38502894
OWN - NLM
STAT- Publisher
LR  - 20240319
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
DP  - 2024 Mar 15
TI  - A Phase 3, Single-Arm Trial to Evaluate the Safety and Immunogenicity of a 
      20-Valent Pneumococcal Conjugate Vaccine in Healthy Children 15 Months Through 
      <18 Years of Age.
LID - 10.1097/INF.0000000000004318 [doi]
AB  - BACKGROUND: A 20-valent pneumococcal conjugate vaccine (PCV20), containing 
      13-valent PCV (PCV13) components and 7 additional polysaccharide conjugates, was 
      developed to extend protection for pneumococcal disease. This phase 3 study 
      assessed the safety and immunogenicity of PCV20 in children. METHODS: In this 
      single-arm study, children (>/=15 months-<18 years of age) received 1 dose of 
      PCV20. Children <5 years of age had >/=3 prior doses of PCV13; children >/=5 years 
      were recruited regardless of previous PCV receipt. Serotype-specific IgG 
      concentrations and opsonophagocytic activity (OPA) titers were measured before 
      and 1 month after PCV20. Local reactions and systemic events, adverse events 
      (AEs), serious AEs, and newly diagnosed chronic medical conditions were 
      collected. RESULTS: Of 839 enrolled participants, 831 (>99%) were vaccinated, and 
      819 (>97%) completed all study visits. Local reactions and systemic events were 
      mostly mild to moderate in severity. No serious AEs were considered 
      PCV20-related. IgG geometric mean fold rises (GMFRs) from before to 1 month after 
      PCV20 ranged from 27.9-1847.7 (7 additional serotypes) and 2.9-44.9 (PCV13 
      serotypes) in children <5 years of age, and 10.5-187.7 (7 additional serotypes) 
      and 4.3-127.9 (PCV13 serotypes) in children >/=5 years old. OPA GMFRs from before 
      to 1 month after PCV20 ranged from 12.4-983.6 to 2.8-52.9 in children <5 years of 
      age and from 11.5-499.0 to 5.3-147.9 in children >/=5 years of age. CONCLUSIONS: 
      Among children >/=15 months through <18 years of age, PCV20 was well tolerated and 
      induced robust responses to all 20 serotypes, supporting the use of PCV20 in 
      children.
CI  - Copyright (c) 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Meyer, Jay
AU  - Meyer J
AD  - From the Meridan Clinical Research, Lincoln, Nebraska.
FAU - Silas, Peter
AU  - Silas P
AD  - Wee Care Pediatrics, Syracuse, Utah.
FAU - Ouedraogo, G Laissa
AU  - Ouedraogo GL
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - McElwee, Kathleen
AU  - McElwee K
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Keep, Georgina
AU  - Keep G
AD  - Vaccine Research and Development, Pfizer UK, Hurley, UK.
FAU - Trammel, James
AU  - Trammel J
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Peng, Yahong
AU  - Peng Y
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Scully, Ingrid L
AU  - Scully IL
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, New York.
FAU - Scott, Daniel A
AU  - Scott DA
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
FAU - Watson, Wendy
AU  - Watson W
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, Pennsylvania.
LA  - eng
PT  - Journal Article
DEP - 20240315
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
SB  - IM
EDAT- 2024/03/19 18:42
MHDA- 2024/03/19 18:42
CRDT- 2024/03/19 16:03
PHST- 2024/03/19 18:42 [medline]
PHST- 2024/03/19 18:42 [pubmed]
PHST- 2024/03/19 16:03 [entrez]
AID - 00006454-990000000-00793 [pii]
AID - 10.1097/INF.0000000000004318 [doi]
PST - aheadofprint
SO  - Pediatr Infect Dis J. 2024 Mar 15. doi: 10.1097/INF.0000000000004318.