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Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial.
Hum Vaccin Immunother. 2019; 15(2):444-451.HV

Abstract

Immune responses to 13-valent pneumococcal conjugate vaccine (PCV13) and quadrivalent inactivated influenza vaccine (QIV) in older adults may vary with coadministration and previous pneumococcal polysaccharide vaccination. This study assessed safety and noninferiority of immune responses to coadministered PCV13 and QIV compared with each vaccine given alone. Adults ≥50 years old preimmunized with ≥1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) ≥1 year before enrollment were randomized 1:1 to receive PCV13+QIV then placebo 1 month later or placebo+QIV then PCV13 1 month later. Administration of PCV13 and placebo was blinded; QIV was administered open-label. Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after PCV13, and influenza hemagglutination inhibition assay GMTs 1 month after QIV were measured. Prespecified noninferiority was demonstrated by a lower bound of the 2-sided 95% CI for geometric mean ratios >0.5. Safety endpoints included proportions of subjects with adverse and serious adverse events. Of 882 randomized subjects, 846 comprised the evaluable immunogenicity population. Immune responses to all 13 pneumococcal serotypes and all 4 influenza strains 1 month after PCV13+QIV were noninferior to responses 1 month after each vaccine given alone. No safety concerns were identified. Immune responses to coadministered PCV13 and QIV were noninferior to responses after each vaccine given alone, although generally lower for coadministered PCV13. PCV13 and QIV can be administered concomitantly to adults ≥50 years of age preimmunized with PPSV23.

Authors+Show Affiliations

a Pfizer Vaccine Clinical Research & Development , Pearl River , NY , USA.b Kaiser Permanente Vaccine Study Center , Oakland , CA , USA.c Jacksonville Center for Clinical Research , Jacksonville , FL , USA.d Pfizer Vaccine Clinical Research & Development , Collegeville , PA , USA.e Department of Biostatistics , Syneos Health , Princeton , NJ , USA.d Pfizer Vaccine Clinical Research & Development , Collegeville , PA , USA.f Pfizer Vaccine Research & Development , Tadworth , Surrey , UK.a Pfizer Vaccine Clinical Research & Development , Pearl River , NY , USA.a Pfizer Vaccine Clinical Research & Development , Pearl River , NY , USA.a Pfizer Vaccine Clinical Research & Development , Pearl River , NY , USA.d Pfizer Vaccine Clinical Research & Development , Collegeville , PA , USA.g Vaccines Research and Development , Pfizer Pharma GmbH , Berlin , Germany.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30303436

Citation

Thompson, Allison R., et al. "Coadministration of 13-valent Pneumococcal Conjugate and Quadrivalent Inactivated Influenza Vaccines in Adults Previously Immunized With Polysaccharide Pneumococcal Vaccine 23: a Randomized Clinical Trial." Human Vaccines & Immunotherapeutics, vol. 15, no. 2, 2019, pp. 444-451.
Thompson AR, Klein NP, Downey HJ, et al. Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial. Hum Vaccin Immunother. 2019;15(2):444-451.
Thompson, A. R., Klein, N. P., Downey, H. J., Patterson, S., Sundaraiyer, V., Watson, W., Clarke, K., Jansen, K. U., Sebastian, S., Gruber, W. C., Scott, D. A., & Schmöele-Thoma, B. (2019). Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial. Human Vaccines & Immunotherapeutics, 15(2), 444-451. https://doi.org/10.1080/21645515.2018.1533777
Thompson AR, et al. Coadministration of 13-valent Pneumococcal Conjugate and Quadrivalent Inactivated Influenza Vaccines in Adults Previously Immunized With Polysaccharide Pneumococcal Vaccine 23: a Randomized Clinical Trial. Hum Vaccin Immunother. 2019;15(2):444-451. PubMed PMID: 30303436.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial. AU - Thompson,Allison R, AU - Klein,Nicola P, AU - Downey,H Jackson, AU - Patterson,Scott, AU - Sundaraiyer,Vani, AU - Watson,Wendy, AU - Clarke,Keri, AU - Jansen,Kathrin U, AU - Sebastian,Shite, AU - Gruber,William C, AU - Scott,Daniel A, AU - Schmöele-Thoma,Beate, Y1 - 2018/10/25/ PY - 2018/10/12/pubmed PY - 2020/2/13/medline PY - 2018/10/11/entrez KW - PPSV23 KW - Prevnar 13 KW - adults KW - coadministration KW - quadrivalent inactivated influenza vaccine SP - 444 EP - 451 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 15 IS - 2 N2 - Immune responses to 13-valent pneumococcal conjugate vaccine (PCV13) and quadrivalent inactivated influenza vaccine (QIV) in older adults may vary with coadministration and previous pneumococcal polysaccharide vaccination. This study assessed safety and noninferiority of immune responses to coadministered PCV13 and QIV compared with each vaccine given alone. Adults ≥50 years old preimmunized with ≥1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) ≥1 year before enrollment were randomized 1:1 to receive PCV13+QIV then placebo 1 month later or placebo+QIV then PCV13 1 month later. Administration of PCV13 and placebo was blinded; QIV was administered open-label. Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month after PCV13, and influenza hemagglutination inhibition assay GMTs 1 month after QIV were measured. Prespecified noninferiority was demonstrated by a lower bound of the 2-sided 95% CI for geometric mean ratios >0.5. Safety endpoints included proportions of subjects with adverse and serious adverse events. Of 882 randomized subjects, 846 comprised the evaluable immunogenicity population. Immune responses to all 13 pneumococcal serotypes and all 4 influenza strains 1 month after PCV13+QIV were noninferior to responses 1 month after each vaccine given alone. No safety concerns were identified. Immune responses to coadministered PCV13 and QIV were noninferior to responses after each vaccine given alone, although generally lower for coadministered PCV13. PCV13 and QIV can be administered concomitantly to adults ≥50 years of age preimmunized with PPSV23. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/30303436/Coadministration_of_13_valent_pneumococcal_conjugate_and_quadrivalent_inactivated_influenza_vaccines_in_adults_previously_immunized_with_polysaccharide_pneumococcal_vaccine_23:_a_randomized_clinical_trial_ DB - PRIME DP - Unbound Medicine ER -