Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults

Robert W. Frenck, Alejandra Gurtman, John Rubino, William Smith, Martin Van Cleeff, Deepthi Jayawardene, Peter C. Giardina, Emilio A. Emini, William C. Gruber, Daniel A. Scott, Beate Schmöle-Thomag

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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.

Original languageEnglish (US)
Pages (from-to)1296-1303
Number of pages8
JournalClinical and Vaccine Immunology
Volume19
Issue number8
DOIs
StatePublished - Aug 1 2012

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Conjugate Vaccines
Inactivated Vaccines
Influenza Vaccines
Randomized Controlled Trials
Hemagglutination
Assays
Immunoglobulin G
Placebos
Immunosorbents
Pneumococcal Vaccines
Random Allocation
Antibody Formation
Vaccines
Enzyme-Linked Immunosorbent Assay
13-valent pneumococcal vaccine
Safety
Injections
Serogroup
Antibodies
Enzymes

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Clinical Biochemistry
  • Microbiology (medical)

Cite this

Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. / Frenck, Robert W.; Gurtman, Alejandra; Rubino, John; Smith, William; Van Cleeff, Martin; Jayawardene, Deepthi; Giardina, Peter C.; Emini, Emilio A.; Gruber, William C.; Scott, Daniel A.; Schmöle-Thomag, Beate.

In: Clinical and Vaccine Immunology, Vol. 19, No. 8, 01.08.2012, p. 1296-1303.

Research output: Contribution to journalArticle

Frenck, RW, Gurtman, A, Rubino, J, Smith, W, Van Cleeff, M, Jayawardene, D, Giardina, PC, Emini, EA, Gruber, WC, Scott, DA & Schmöle-Thomag, B 2012, 'Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults', Clinical and Vaccine Immunology, vol. 19, no. 8, pp. 1296-1303. https://doi.org/10.1128/CVI.00176-12
Frenck, Robert W. ; Gurtman, Alejandra ; Rubino, John ; Smith, William ; Van Cleeff, Martin ; Jayawardene, Deepthi ; Giardina, Peter C. ; Emini, Emilio A. ; Gruber, William C. ; Scott, Daniel A. ; Schmöle-Thomag, Beate. / Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. In: Clinical and Vaccine Immunology. 2012 ; Vol. 19, No. 8. pp. 1296-1303.
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