Evidence map›Paper›PMID 22267715›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

A cell culture-derived influenza vaccine provides consistent protection against infection and reduces the duration and severity of disease in infected individuals.

Hartmut J Ehrlich, Julia Singer, Gregory Berezuk, Sandor Fritsch, Gerald Aichinger, Mary Kate Hart, Wael El-Amin, Daniel Portsmouth, Otfried Kistner, P Noel Barrett

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00566345 (Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT00566345 phase3completednot on this map

Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)

TypeinterventionalSponsorAlachua Government Services, Inc.Ran2007 to 2008Enrolled3,670ConditionsInfluenzaArmsInactivated seasonal influenza vaccine (split virus, Vero cell-derived), Phosphate buffered saline
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Trial
  3. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.The journals of gerontology. Series A, Biological sciences and medical sciences · 2019
    Trial
  4. Trial
  5. Review
  6. Burden-of-illness vaccine efficacy.Pharmaceutical statistics · 2020
    Article
  7. Review
  8. [Vaccination in advanced age].Der Internist · 2018
    Review
  9. Advances in novel influenza vaccines: a patent review.Journal of microbiology (Seoul, Korea) · 2016
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Influenza B outbreak in a primary school in Adelaide, Australia, 2011.Western Pacific surveillance and response journal : WPSAR · 2012
    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

10 authors at 2 institutions in 2 countries.

Hartmut J EhrlichGlobal R&D, Baxter BioScience, Vienna, Austria.
Julia Singer
Gregory Berezuk
Sandor Fritsch
Gerald Aichinger
Mary Kate Hart
Wael El-Amin
Daniel Portsmouth
Otfried Kistner
P Noel Barrett
Baxter (Austria) · ATBaxter (United States) · US

Funding

PHS HHS HHS0100200600013C
6 · The paper itself

Abstract

backgroundCurrent knowledge of the consistency of protection induced by seasonal influenza vaccines over the duration of a full influenza season is limited, and little is known about the clinical course of disease in individuals who become infected despite vaccination.

methodsData from a randomized double-blind placebo-controlled clinical trial undertaken in healthy young adults in the 2008-2009 influenza season were used to investigate the weekly cumulative efficacy of a Vero cell culture-derived influenza vaccine. In addition, the duration and severity of disease in vaccine and placebo recipients with cell culture-confirmed influenza infection were compared.

resultsVaccine efficacy against matching strains was consistently high (73%-82%) throughout the study, including the entire period of the influenza season during which influenza activity was above the epidemic threshold. Vaccine efficacy was also consistent (68%-83%) when calculated for all strains, irrespective of antigenic match. Vaccination also ameliorated disease symptoms when infection was not prevented. Bivariate analysis of duration and severity showed a significant amelioration of myalgia (P = .003), headache (P = .025), and fatigue (P = .013) in infected vaccinated subjects compared with placebo. Cough (P = .143) and oropharyngeal pain (P = .083) were also reduced in infected vaccinated subjects.

conclusionsA Vero cell culture-derived influenza vaccine provides consistently high levels of protection against cell culture-confirmed infection by seasonal influenza virus and significantly reduces the duration and severity of disease in those individuals in which infection is not prevented. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT00566345.

Indexed as

AdultAnimalsBiotechnologyCell Culture TechniquesChlorocebus aethiopsDouble-Blind MethodHumansInfluenza, HumanInfluenza VaccinesMiddle AgedPlacebosSeverity of Illness IndexTechnology, PharmaceuticalTime FactorsVero CellsYoung AdultInfluenza VaccinesPlacebos

Identifiers

PMID22267715
PMCPMC3297649
OpenAlexW2125621152

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.