title: Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults.
abstract: BACKGROUND
  Concomitant administration of influenza and pneumococcal vaccines facilitates their uptake by older adults; however, data on immunogenicity and safety of concomitant administration of adjuvanted trivalent inactivated influenza vaccine (aIIV3) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) have not been reported.
  
  
  METHODS
  Subjects aged ≥65 years (N=224) were randomized 1:1:1:1 to receive MF59-aIIV3 alone, MF59-aIIV3+PPSV23 in contralateral arms, MF59-aIIV3+PPSV23 in the same arm or PPSV23 alone (Clinical Trial Number - NCT02225327). Hemagglutination inhibition assay and multiplex opsonophagocytic killing assay were used to compare immunogenicity after single or concomitant vaccination.
  
  
  RESULTS
  All groups met immunogenicity criteria for the influenza vaccine in older adults with similar seroconversion rates and geometric mean fold-increases, irrespective of concomitant vaccinations and injection site. For each pneumococcal serotype, opsonic index (OI) increased markedly after the PPSV23 vaccination, irrespective of the concomitant influenza vaccine. All subjects showed an OI≥8 for serotypes 6B, 18C and 19A post-vaccination, with a suggestion that the ipsilateral concomitant vaccination might be associated with higher OIs for some antigens. Local and systemic adverse events were more common in subjects receiving PPSV23 compared to those receiving aIIV3 alone.
  
  
  CONCLUSIONS
  No interference was observed with antibody responses to influenza or pneumococcal antigens when aIIV3 and PPSV23 were administered concomitantly.
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: infection@korea.ac.kr.
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@medimail.co.kr.
authors.forename: Hee Jin
authors.initials: HJ
authors.lastname: Cheong
authors.affiliation: Novartis Vaccines, Cambridge, MA, USA.
authors.forename: T F
authors.initials: TF
authors.lastname: Tsai
authors.affiliation: Novartis Korea Ltd., Seoul, Republic of Korea.
authors.forename: Hyun-Ah
authors.initials: HA
authors.lastname: Chang
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: Ji Ho
authors.initials: JH
authors.lastname: Jeon
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Seong Hee
authors.initials: SH
authors.lastname: Kang
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
authors.forename: Eun Ju
authors.initials: EJ
authors.lastname: Jeong
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; 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; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007115:Immunization Schedule; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D009895:Opsonin Proteins / Q000097:blood; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D058248:Serum Bactericidal Antibody Assay; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*; D016896:Treatment Outcome; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000276:Adjuvants, Immunologic; D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D009895:Opsonin Proteins; D022242:Pneumococcal Vaccines; D011136:Polysorbates; D015164:Vaccines, Inactivated; D013185:Squalene
keywords: Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal polysaccharide vaccine