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

被引:2
作者
Meyer, Jay [1 ]
Silas, Peter [2 ]
Ouedraogo, G. Laissa [3 ]
McElwee, Kathleen [3 ]
Keep, Georgina [4 ]
Trammel, James [3 ]
Peng, Yahong [3 ]
Scully, Ingrid L. [5 ]
Gruber, William C. [5 ]
Scott, Daniel A. [3 ]
Watson, Wendy [3 ]
机构
[1] Meridan Clin Res, Lincoln, NE USA
[2] Wee Care Pediat, Syracuse, UT USA
[3] Pfizer Inc, Vaccine Res & Dev, Collegeville, PA USA
[4] Pfizer UK, Vaccine Res & Dev, Hurley, England
[5] Pfizer Inc, Vaccine Res & Dev, Pearl River, NY USA
关键词
children; immunogenicity and safety; 20-valent pneumococcal conjugate vaccine; Streptococcus pneumoniae; clinical trial; DISEASE; INFANTS; IMPACT;
D O I
10.1097/INF.0000000000004318
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
引用
收藏
页码:574 / 581
页数:8
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