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Vaccine. 2016 Dec 2. pii: S0264-410X(16)31109-4. doi: 10.1016/j.vaccine.2016.11.047. [Epub ahead of print]
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults.
Song JY1, Cheong HJ2, Hyun HJ3, Seo YB4, Lee J4, Wie SH5, Choi MJ3, Choi WS3, Noh JY1, Yun JW3, Yun JG3, Kim WJ1.
Author information
Abstract
BACKGROUND:
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.
METHODS:
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.
RESULTS:
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.
CONCLUSIONS:
Concomitant MF59-aTIV and PCV13 administration showed no interference with antibody response and showed good safety profiles. (Clinical Trial Number - NCT02215863).
Copyright © 2016 Elsevier Ltd. All rights reserved.
KEYWORDS:
Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal conjugate vaccine
PMID: 27919632 DOI: 10.1016/j.vaccine.2016.11.047
[PubMed - as supplied by publisher]
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults.
Song JY1, Cheong HJ2, Hyun HJ3, Seo YB4, Lee J4, Wie SH5, Choi MJ3, Choi WS3, Noh JY1, Yun JW3, Yun JG3, Kim WJ1.
Author information
Abstract
BACKGROUND:
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.
METHODS:
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.
RESULTS:
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.
CONCLUSIONS:
Concomitant MF59-aTIV and PCV13 administration showed no interference with antibody response and showed good safety profiles. (Clinical Trial Number - NCT02215863).
Copyright © 2016 Elsevier Ltd. All rights reserved.
KEYWORDS:
Emulsion adjuvant; Influenza vaccine; MF59; Pneumococcal conjugate vaccine
PMID: 27919632 DOI: 10.1016/j.vaccine.2016.11.047
[PubMed - as supplied by publisher]