Evidence map›Paper›PMID 29561248›Full record

Trial reportHuman vaccines & immunotherapeutics2018

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 and 1 more

Registry-linked trialOpen access · bronzeAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02592486 (A Randomized, Open-label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02592486 phase4completednot on this map

A Randomized, Open-label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine

TypeinterventionalSponsorKameda Medical CenterRan2015 to 2016Enrolled162ConditionsPneumococcal Pneumonia, InfluenzaArmsSimultaneous administration of Pneumovax NP® and Fluvic HA syringe®, Sequential administration of Pneumovax NP® and Fluvic HA syringe®
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Journal of preventive medicine and hygiene · 2026
    Article
  9. Review
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  11. Article
  12. Review
  13. Review
  14. Article
  15. Influenza and Pneumococcal Vaccination in Coronary Artery Disease.Journal of atherosclerosis and thrombosis · 2021
    Article
  16. Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Kei Nakashimaa Department of Pulmonology , Kameda Medical Center , Chiba , Japan.
Masahiro Aoshimaa Department of Pulmonology , Kameda Medical Center , Chiba , Japan.
Satoko Ohfujib Department of Public Health , Osaka City University Graduate School of Medicine , Osaka , Japan.
Satoshi Yamawakia Department of Pulmonology , Kameda Medical Center , Chiba , Japan.
Masahiro Nemotoa Department of Pulmonology , Kameda Medical Center , Chiba , Japan.
Shinya Hasegawac Department of General Internal Medicine , Kameda Medical Center , Chiba , Japan.
Satoshi Nomaa Department of Pulmonology , Kameda Medical Center , Chiba , Japan.
Masafumi Misawaa Department of Pulmonology , Kameda Medical Center , Chiba , Japan.
Naoto Hosokawad Department of Infectious Disease , Kameda Medical Center , Chiba , Japan.
Makito Yaegashic Department of General Internal Medicine , Kameda Medical Center , Chiba , Japan.
Yoshihito Otsukae Department of Laboratory Medicine , Kameda Medical Center , Chiba , Japan.
Kameda Medical Center · JPOsaka City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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]).

Indexed as

Immunogenicity, VaccineAgedAge FactorsAntibodies, BacterialDrug Administration ScheduleFemaleHumansImmunoglobulin GInfluenza, HumanInfluenza VaccinesMaleMass VaccinationPneumococcal InfectionsPneumococcal VaccinesSerogroupStreptococcus pneumoniae23-valent pneumococcal capsular polysaccharide vaccineAntibodies, BacterialImmunoglobulin GInfluenza VaccinesPneumococcal Vaccines23-valent pneumococcal polysaccharide vaccineElderly populationImmunogenicityQuadrivalent influenza vaccineSimultaneous administration

Identifiers

PMID29561248
PMCPMC6150043
OpenAlexW2791099574

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.