Rethinking results from the Japanese 23-valent pneumococcal polysaccharide vaccine randomized clinical trial.

Aged, 80 and over Antibodies, Bacterial / blood Bias Data Interpretation, Statistical Double-Blind Method Humans Japan Meta-Analysis as Topic Pneumococcal Vaccines / administration & dosage Pneumonia, Pneumococcal / mortality Randomized Controlled Trials as Topic Serogroup Streptococcus pneumoniae Vaccine Potency
Japan Pneumococcal conjugate vaccine Pneumococcal polysaccharide vaccine Pneumococcus Randomized clinical trial Vaccine Vaccine efficacy Validity

Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
14 08 2019
Historique:
received: 21 03 2019
revised: 08 07 2019
accepted: 10 07 2019
pubmed: 23 7 2019
medline: 7 10 2020
entrez: 23 7 2019
Statut: ppublish

Résumé

We review a previously published randomized clinical trial of 23-valent pneumococcal polysaccharide vaccine (PPSV23) that has been used extensively globally to support PPSV23 use among adults. We argue that serious issues with internal and external validity exist that affect the usefulness of these data when evaluating pneumococcal vaccines for the general adult population. As one example of internal data inconsistency, the values reported for the percent of all pneumonia cases due to pneumococcus and the vaccine efficacy (VE) for all cause pneumonia are mutually inconsistent, even based on unrealistically high values for PPSV23 VE against vaccine serotypes and the proportion of pneumococcal pneumonias due to vaccine serotypes.

Identifiants

DOI: 10.1016/j.vaccine.2019.07.040 PMID: 31327653
pubmed: 31327653
pii: S0264-410X(19)30931-4
doi: 10.1016/j.vaccine.2019.07.040
pii:
doi:

Substances chimiques

23-valent pneumococcal capsular polysaccharide vaccine 0
Antibodies, Bacterial 0
Pneumococcal Vaccines 0

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

4853-4857

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Bradford D Gessner (BD)

Pfizer Vaccines, Collegeville, PA, USA. Electronic address: Bradford.gessner@pfizer.com.

Christian Theilacker (C)

Pfizer Vaccines, Collegeville, PA, USA.

Luis Jodar (L)

Pfizer Vaccines, Collegeville, PA, USA.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Sujet âgé de 80 ans ou plus › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps antibactériens › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Facteurs épidémiologiques › Biais (épidémiologie) › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Interprétation statistique de données › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Régions géographiques › Iles › Japon › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méta-analyse comme sujet › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antibactériens › Vaccins antistreptococciques › Vaccins antipneumococciques › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie bactérienne › Pneumonie à pneumocoques › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Phénomènes génétiques › Phénotype › Sérogroupe › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Bactéries › Bactéries à Gram positif › Lactobacillales › Streptococcaceae › Streptococcus › Streptococcus pneumoniae › Rethinking results from the Japanese 23-valent...
questionsmedicales.fr › Phénomènes du système immunitaire › Relation dose-réponse (immunologie) › Efficacité du vaccin › Rethinking results from the Japanese 23-valent...