Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial

Kei Nakashima; Masahiro Aoshima; Satoko Ohfuji; Satoshi Yamawaki; Masahiro Nemoto; Shinya Hasegawa; Satoshi Noma; Masafumi Misawa; Naoto Hosokawa; Makito Yaegashi; Yoshihito Otsuka

doi:10.1080/21645515.2018.1455476

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Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial

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Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial

Kei Nakashima, Masahiro Aoshima, Satoko Ohfuji, Satoshi Yamawaki, Masahiro Nemoto, Shinya Hasegawa, Satoshi Noma, Masafumi Misawa, Naoto Hosokawa, Makito Yaegashi, …

Human vaccines & immunotherapeutics, Vol.14(8), pp.1923-1930

2018

DOI: 10.1080/21645515.2018.1455476

PMID: 29561248

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Abstract

It is unclear whether simultaneous administration of a 23-valent pneumococcal polysaccharide vaccine (PPSV23) and a quadrivalent influenza vaccine (QIV) produces immunogenicity in older individuals. This study tested the hypothesis that the pneumococcal antibody response elicited by simultaneous administration of PPSV23 and QIV in older individuals is not inferior to that elicited by sequential administration of PPSV23 and QIV. We performed a single-center, randomized, open-label, non-inferiority trial comprising 162 adults aged ≥65 years randomly assigned to either the simultaneous (simultaneous injections of PPSV23 and QIV) or sequential (control; PPSV23 injected 2 weeks after QIV vaccination) groups. Pneumococcal immunoglobulin G (IgG) titers of serotypes 23F, 3, 4, 6B, 14, and 19A were assessed. The primary endpoint was the serotype 23F response rate (a ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination). With the non-inferiority margin set at 20% fewer patients, the response rate of serotype 23F in the simultaneous group (77.8%) was not inferior to that of the sequential group (77.6%; difference, 0.1%; 90% confidence interval, −10.8% to 11.1%). None of the pneumococcal IgG serotype titers were significantly different between the groups 4-6 weeks after vaccination. Simultaneous administration did not show a significant decrease in seroprotection odds ratios for H1N1, H3N2, or B/Phuket influenza strains other than B/Texas. Additionally, simultaneous administration did not increase adverse reactions. Hence, simultaneous administration of PPSV23 and QIV shows an acceptable immunogenicity that is comparable to sequential administration without an increase in adverse reactions. (This study was registered with ClinicalTrials.gov [NCT02592486]).

23-valent pneumococcal polysaccharide vaccine

Elderly population

Immunogenicity

Quadrivalent influenza vaccine

Simultaneous administration

Details

Title: Subtitle: Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial
Creators: Kei Nakashima - Kameda Medical Center
Masahiro Aoshima - Kameda Medical Center
Satoko Ohfuji - Osaka City University
Satoshi Yamawaki - Kameda Medical Center
Masahiro Nemoto - Kameda Medical Center
Shinya Hasegawa - Kameda Medical Center
Satoshi Noma - Kameda Medical Center
Masafumi Misawa - Kameda Medical Center
Naoto Hosokawa - Kameda Medical Center
Makito Yaegashi - Kameda Medical Center
Yoshihito Otsuka - Kameda Medical Center
Resource Type: Journal article
Publication Details: Human vaccines & immunotherapeutics, Vol.14(8), pp.1923-1930
DOI: 10.1080/21645515.2018.1455476
PMID: 29561248
NLM abbreviation: Hum Vaccin Immunother
ISSN: 2164-5515
eISSN: 2164-554X
Publisher: Taylor & Francis
Number of pages: 8
Grant note: Merck Sharp and Dohme (10.13039/100009947)
Language: English
Date published: 2018
Academic Unit: Internal Medicine
Record Identifier: 9985177945002771

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