title: 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.
abstract: 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.
authors.affiliation: Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany. t.schwarz@juliusspital.de
authors.forename: T F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: J
authors.initials: J
authors.lastname: Flamaing
authors.forename: H C
authors.initials: HC
authors.lastname: Rümke
authors.forename: J
authors.initials: J
authors.lastname: Penzes
authors.forename: C
authors.initials: C
authors.lastname: Juergens
authors.forename: A
authors.initials: A
authors.lastname: Wenz
authors.forename: D
authors.initials: D
authors.lastname: Jayawardene
authors.forename: P
authors.initials: P
authors.lastname: Giardina
authors.forename: E A
authors.initials: EA
authors.lastname: Emini
authors.forename: W C
authors.initials: WC
authors.lastname: Gruber
authors.forename: B
authors.initials: B
authors.lastname: Schmoele-Thoma
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000097:blood; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000276:immunology; D013296:Streptococcus pneumoniae / Q000276:immunology; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
chemical_list: C538862:13-valent pneumococcal vaccine; D007074:Immunoglobulin G; D007252:Influenza Vaccines; D010919:Placebos; D022242:Pneumococcal Vaccines; D011135:Polysaccharides, Bacterial; D018074:Vaccines, Conjugate