Jacek Wysocki1, Jerzy Brzostek2, Henryk Szymański3, Bogusław Tetiurka4, Ewa Toporowska-Kowalska5, Krystyna Wasowska-Królikowska6, Denise A Sarkozy7, Peter C Giardina8, William C Gruber9, Emilio A Emini10, Daniel A Scott11. 1. Department of Preventive Medicine, Poznan University of Medical Sciences, ul. Smoluchowskiego 11, 60-179 Poznan, Poland. Electronic address: jwysocki@ump.edu.pl. 2. NZOZ w Debicy, Poradnia, Debica, Poland. Electronic address: jerzy_br@poczta.onet.pl. 3. NZOZ Praktyka Lekarza, Rodzinnego Alina Grocka-Wlaźlak, Oborniki Śląskie, Poland. Electronic address: henryktomasz@poczta.onet.pl. 4. NZOZ Salmed, Poradnia, Leczna, Poland. Electronic address: salmed@salmed.eu. 5. Department of Paediatric Allergology, Gastroenterology and Nutrition, Medical University of Lodz, Lodz, Poland. Electronic address: etka@op.pl. 6. Department of Paediatric Allergology, Gastroenterology and Nutrition, Medical University of Lodz, Lodz, Poland. Electronic address: etka@csk.am.lodz.pl. 7. Pfizer Inc., 500 Arcola Road, Collegeville, PA, USA. Electronic address: dasarkozy@verizon.net. 8. Vaccine Clinical Research, Pfizer Inc., 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: peter.giardina@pfizer.com. 9. Vaccine Clinical Research, Pfizer Inc., 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: bill.gruber@pfizer.com. 10. Vaccine Clinical Research, Pfizer Inc., 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: Emilio.emini@pfizer.com. 11. Vaccine Clinical Research, Pfizer Inc., 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: dan.scott@pfizer.com.
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 ≥0.35μg/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.
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 ≥0.35μg/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.
Authors: Grant A Mackenzie; Isaac Osei; Rasheed Salaudeen; Ousman Secka; Umberto D'Alessandro; Ed Clarke; Jonas Schmidt-Chanasit; Paul V Licciardi; Cattram Nguyen; Brian Greenwood; Kim Mulholland Journal: Trials Date: 2022-01-15 Impact factor: 2.728
Authors: Grant A Mackenzie; Isaac Osei; Rasheed Salaudeen; Ilias Hossain; Benjamin Young; Ousman Secka; Umberto D'Alessandro; Arto A Palmu; Jukka Jokinen; Jason Hinds; Stefan Flasche; Kim Mulholland; Cattram Nguyen; Brian Greenwood Journal: Trials Date: 2022-01-24 Impact factor: 2.728
Authors: N S Alharbi; A M Al-Barrak; M S Al-Moamary; M O Zeitouni; M M Idrees; M O Al-Ghobain; A A Al-Shimemeri; Mohamed S Al-Hajjaj Journal: Ann Thorac Med Date: 2016 Apr-Jun Impact factor: 2.219