Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults

• Published in: Vaccine Vol. 35; no. 2; pp. 313 - 320
• Main Authors: Song, Joon Young, Cheong, Hee Jin, Hyun, Hak Jun, Seo, Yu Bin, Lee, Jacob, Wie, Seong-Heon, Choi, Min Joo, Choi, Won Suk, Noh, Ji Yun, Yun, Jae Won, Yun, Jin Gu, Kim, Woo Joo
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 05.01.2017; Elsevier Limited
• Subjects: Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - adverse effects; Aged; Aged, 80 and over; Allergy and Immunology; Aluminum; antibodies; Antibody Formation; Antigens; Clinical trials; Confidence intervals; Drug Interactions; Drug-Related Side Effects and Adverse Reactions - epidemiology; elderly; Emulsion adjuvant; FDA approval; Female; geometry; hemagglutination; Hemagglutination Inhibition Tests; Humans; Immunization Schedule; Immunogenicity; Influenza; Influenza vaccine; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Male; MF59; Middle Aged; Older people; Phagocytosis; Pneumococcal conjugate vaccine; Pneumococcal Vaccines - administration & dosage; Pneumococcal Vaccines - adverse effects; Pneumococcal Vaccines - immunology; Polysorbates - administration & dosage; Polysorbates - adverse effects; Safety; seroconversion; serotypes; Squalene - administration & dosage; Squalene - adverse effects; Streptococcus infections; Testing laboratories; vaccination; Vaccines; Vaccines, Inactivated - administration & dosage; Vaccines, Inactivated - adverse effects; Vaccines, Inactivated - immunology; United States > US; Pneumococcal conjugate vaccine; MF59; Influenza vaccine; Emulsion adjuvant
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2016.11.047

•No immune interference was observed when PCV13 and MF59-aTIV were given together.•The immunogenicity criteria of influenza vaccine was met irrespective of concomitant vaccination.•Concomitant vaccination showed good safety profiles. 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).