Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered to older infants and children naïve to pneumococcal vaccination. Issue 14 (30th March 2015)

• Record Type: Journal Article
• Authors: Wysocki, Jacek; Brzostek, Jerzy; Szymański, Henryk; Tetiurka, Bogusław; Toporowska-Kowalska, Ewa; Wasowska-Królikowska, Krystyna; Sarkozy, Denise A.; Giardina, Peter C.; Gruber, William C.; Emini, Emilio A.; Scott, Daniel A.
• Is Part Of: Vaccine. Volume 33:Issue 14(2015)
• Page Start: 1719
• Page End: 1725
• Publication Date: 2015-03-30
• Subjects: Pneumococcal conjugate vaccine -- Vaccine clinical evaluation -- Immunization -- Immunogenicity; AE adverse event -- CI confidence interval -- ELISA enzyme-linked immunosorbent assay -- GMC geometric mean concentration -- Ig immunoglobulin -- IPD invasive pneumococcal disease -- PCV7 7-valent pneumococcal conjugate vaccine -- PCV13 13-valent pneumococcal conjugate vaccine -- SAE serious AE; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2015.02.005
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Some children may not receive pneumococcal conjugate vaccine (PCV) as infants. PCV13 was evaluated in pneumococcal vaccine-naïve children aged 7 months to 5 years. Age-specific "catch-up" vaccination schedules were evaluated. The proportion of immunological responders ranged from 88% to 100% for all 13 serotypes. PCV13 was generally well-tolerated; trend for greater tenderness in older subjects. Abstract: Background: Streptococcus pneumoniae infections are a major cause of morbidity and mortality in children <5 years old worldwide. To increase serotype coverage globally, a 13-valent pneumococcal conjugate vaccine (PCV13) has been developed and approved in many countries worldwide. Objective: Assess the safety and immunogenicity of PCV13 in healthy older infants and children naïve to previous pneumococcal vaccination. Methods: This was a phase 3, open-label, multicenter study conducted in Polish children ( N = 354) who were vaccinated according to 3 age-appropriate catch-up schedules: Group 1 (aged 7 to <12 months) received two PCV13 doses with a booster at 12–16 months of age; Group 2 (aged 12 to <24 months) received two vaccine doses only; and Group 3 (aged 24 to <72 months) received a single dose of PCV13. Statistical analyses were descriptive. The proportion of immunological "responders" achieving serotype-specific antipneumococcal polysaccharide concentrations ≥0.35 μg/mL, 1-month after the last dose of vaccine, was determined for each vaccine serotype. In addition, antipolysaccharide immunoglobulin (Ig) G geometric mean concentrations (GMCs) were calculated. Safety assessments included systemic and local reactions, and adverse events. Results: The proportion of immunological responders was ≥88% across groups for all serotypes. Antipolysaccharide IgG GMCs were generally similar across groups. Each schedule elicited immune response levels against all 13 serotypes comparable to or greater than levels previously reported in infants after a 3-dose series. The 3 catch-up schedules had similar tolerability and safety profiles; a trend was present towards greater local tenderness with increasing age and subsequent dose administration. Conclusions: Immunological responses and safety results support the use of PCV13 for catch-up schedules in older infants and children naïve to pneumococcal vaccination.