title: Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults.
abstract: A randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50 to 59 years (n = 1,116) received TIV with PCV13 (group 1) or placebo (group 2) (1:1 randomization); 1 month later, group 1 received placebo and group 2 received PCV13. A hemagglutination inhibition (HAI) assay for TIV and a standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG) were performed and opsonophagocytic activity (OPA) titers (assessed post hoc) were measured at baseline and 1 and 2 months postvaccination. The rises in HAI assay geometric mean titer (GMT) and percentage of participants in groups 1 and 2 with ≥ 4-fold increases in HAI responses (A/H1N1, 84.0% and 81.2%, respectively; A/H3N2, 71.1% and 69.5%, respectively; and B, 60.6% and 60.3%, respectively) were similar. In group 1, all serotypes met the predefined IgG geometric mean concentration (GMC) ratio noninferiority criterion relative to group 2, but GMCs were lower in group 1 than group 2. When comparing group 1 with group 2, 5 serotypes did not meet the OPA GMT ratio noninferiority criterion, and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in group 1 (86.2%) than group 2 (76.7%; P < 0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.
authors: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. robert.frenck@cchmc.org
authors: Robert W
authors: RW
authors: Frenck
authors: Alejandra
authors: A
authors: Gurtman
authors: John
authors: J
authors: Rubino
authors: William
authors: W
authors: Smith
authors: Martin
authors: M
authors: van Cleeff
authors: Deepthi
authors: D
authors: Jayawardene
authors: Peter C
authors: PC
authors: Giardina
authors: Emilio A
authors: EA
authors: Emini
authors: William C
authors: WC
authors: Gruber
authors: Daniel A
authors: DA
authors: Scott
authors: Beate
authors: B
authors: Schmöle-Thoma
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009895:Opsonin Proteins / Q000097:blood; D010587:Phagocytosis; D010919:Placebos / Q000008:administration & dosage; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000009:adverse effects / Q000379:methods*
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D007074:Immunoglobulin G; D007252:Influenza Vaccines; D009895:Opsonin Proteins; D010919:Placebos; D022242:Pneumococcal Vaccines