title: Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults.
abstract: Concomitant administration of influenza and pneumococcal vaccines could be an efficient strategy to increase vaccine uptake among older adults. Nevertheless, immune interference and safety issues have been a concern when more than one vaccines are administered at the same time.
  
  
  
  Subjects aged ⩾60years were randomized in a 1:1:1 ratio to receive MF59-adjuvanted trivalent inactivated influenza vaccine (MF59-aTIV)+13-valent pneumococcal conjugate vaccine (PCV13) (Group 1), PCV13 alone (Group 2), or MF59-aTIV alone (Group 3). Hemagglutination inhibition (HI) and opsonophagocytic activity (OPA) assays were used to compare immunogenicity after single or concomitant vaccination.
  
  
  
  A total of 1149 subjects (Group 1, N=373; Group 2, N=394; Group 3, N=382) were available for the assessment of immunogenicity and safety. All groups met immunogenicity criteria for the influenza vaccine in older adults with similar seroprotection rates, seroconversion rates, and geometric mean titer (GMT) fold-increases, irrespective of concomitant vaccination. For each pneumococcal serotype, OPA titers increased markedly after the PCV13 vaccination, irrespective of the concomitant influenza vaccination. After concomitant administration, the non-inferiority criteria of GMT ratios were met for all three influenza subtypes and 13 pneumococcal serotypes. No vaccine-related serious adverse events occurred.
  
  
  
  Concomitant MF59-aTIV and PCV13 administration showed no interference with antibody response and showed good safety profiles. (Clinical Trial Number - NCT02215863).
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Joon Young
authors.initials: JY
authors.lastname: Song
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: heejinmd@korea.ac.kr.
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Cheong
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Hak Jun
authors.initials: HJ
authors.lastname: Hyun
authors.affiliation: Hallym University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yu Bin
authors.initials: YB
authors.lastname: Seo
authors.affiliation: Hallym University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jacob
authors.initials: J
authors.lastname: Lee
authors.affiliation: St. Vincent's Hospital, Catholic University of Korea College of Medicine, Suwon, Gyeonggi-do, Republic of Korea.
authors.forename: Seong-Heon
authors.initials: SH
authors.lastname: Wie
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Min Joo
authors.initials: MJ
authors.lastname: Choi
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Won Suk
authors.initials: WS
authors.lastname: Choi
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Ji Yun
authors.initials: JY
authors.lastname: Noh
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jae Won
authors.initials: JW
authors.lastname: Yun
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jin Gu
authors.initials: JG
authors.lastname: Yun
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asian Pacific Influenza Institute (APII), Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000368:Aged; D000369:Aged, 80 and over; D000917:Antibody Formation; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007115:Immunization Schedule; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D010587:Phagocytosis; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C538862:13-valent pneumococcal vaccine; D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D022242:Pneumococcal Vaccines; D011136:Polysorbates; D015164:Vaccines, Inactivated; D013185:Squalene
keywords: Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal conjugate vaccine