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Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults.
Clin Vaccine Immunol. 2012 Aug; 19(8):1296-303.CV

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.

Authors+Show Affiliations

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. robert.frenck@cchmc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22739693

Citation

Frenck, Robert W., et al. "Randomized, Controlled Trial of a 13-valent Pneumococcal Conjugate Vaccine Administered Concomitantly With an Influenza Vaccine in Healthy Adults." Clinical and Vaccine Immunology : CVI, vol. 19, no. 8, 2012, pp. 1296-303.
Frenck RW, Gurtman A, Rubino J, et al. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012;19(8):1296-303.
Frenck, R. W., Gurtman, A., Rubino, J., Smith, W., van Cleeff, M., Jayawardene, D., Giardina, P. C., Emini, E. A., Gruber, W. C., Scott, D. A., & Schmöle-Thoma, 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 : CVI, 19(8), 1296-303. https://doi.org/10.1128/CVI.00176-12
Frenck RW, et al. Randomized, Controlled Trial of a 13-valent Pneumococcal Conjugate Vaccine Administered Concomitantly With an Influenza Vaccine in Healthy Adults. Clin Vaccine Immunol. 2012;19(8):1296-303. PubMed PMID: 22739693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. AU - Frenck,Robert W,Jr AU - Gurtman,Alejandra, AU - Rubino,John, AU - Smith,William, AU - van Cleeff,Martin, AU - Jayawardene,Deepthi, AU - Giardina,Peter C, AU - Emini,Emilio A, AU - Gruber,William C, AU - Scott,Daniel A, AU - Schmöle-Thoma,Beate, Y1 - 2012/06/27/ PY - 2012/6/29/entrez PY - 2012/6/29/pubmed PY - 2012/12/10/medline SP - 1296 EP - 303 JF - Clinical and vaccine immunology : CVI JO - Clin. Vaccine Immunol. VL - 19 IS - 8 N2 - 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. SN - 1556-679X UR - https://www.unboundmedicine.com/medline/citation/22739693/full_citation L2 - http://cvi.asm.org/cgi/pmidlookup?view=long&amp;pmid=22739693 DB - PRIME DP - Unbound Medicine ER -