A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ≥65 years

• Published in: Vaccine Vol. 29; no. 32; pp. 5195 - 5202
• Main Authors: Schwarz, T.F, Flamaing, J, Rümke, H.C, Penzes, J, Juergens, C, Wenz, A, Jayawardene, D, Giardina, P, Emini, E.A, Gruber, W.C, Schmoele-Thoma, B
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 18-07-2011; Elsevier; Elsevier Limited
• Subjects: 13-Valent pneumococcal conjugate vaccine; adults; Aged; Aged, 80 and over; Allergy and Immunology; Applied microbiology; Bacteriology; Biological and medical sciences; blood; Double-Blind Method; Europe; Female; Fundamental and applied biological sciences. Psychology; Humans; immune response; Immunization Schedule; Immunogenicity; immunoglobulin G; Immunoglobulin G - blood; Influenza; Influenza A virus - immunology; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Male; Microbiology; Miscellaneous; Older people; patients; Placebos - administration & dosage; Pneumococcal Vaccines - administration & dosage; Pneumococcal Vaccines - adverse effects; Pneumococcal Vaccines - immunology; Pneumonia; Polysaccharides, Bacterial - immunology; Safety; Streptococcus pneumoniae; Streptococcus pneumoniae - immunology; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Conjugate - adverse effects; Vaccines, Conjugate - immunology; Europe; 13-Valent pneumococcal conjugate vaccine; Safety; Immunogenicity; Europe; Infection; Streptococcaceae; Viral disease; Influenza; Bacteria; Micrococcales; Vaccine; Streptococcus pneumoniae
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2011.05.031

This randomized, double-blind study evaluated concomitant administration of 13-valent pneumococcal conjugate vaccine (PCV13) and trivalent inactivated influenza vaccine (TIV) in adults aged ≥65 years who were naïve to 23-valent pneumococcal polysaccharide vaccine. Patients (N=1160) were randomized 1:1 to receive PCV13+TIV followed by placebo, or Placebo+TIV followed by PCV13 at 0 and 1 months, with blood draws at 0, 1, and 2 months. Slightly lower pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G geometric mean concentrations were observed with PCV13+TIV relative to PCV13. Concomitant PCV13+TIV demonstrates acceptable immunogenicity and safety compared with either agent given alone.