Evidence map›Paper›PMID 28417321›Full record

ArticleDrug safety2017

Adjuvanted (AS03) A/H1N1 2009 Pandemic Influenza Vaccines and Solid Organ Transplant Rejection: Systematic Signal Evaluation and Lessons Learnt.

Gaël Dos Santos, Harry A Seifert, Vincent Bauchau, Vivek Shinde, Dominique M Barbeau, Catherine Cohet

Abstract read
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Seasonal influenza vaccine in immunocompromised persons.Human vaccines & immunotherapeutics · 2018
    Review
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

6 authors.

Gaël Dos SantosBusiness & Decision Life Sciences (on behalf of GSK), Brussels, Belgium. gael.x.dos-santos@gsk.com.
Harry A SeifertGSK, 2301 Renaissance Blvd., King of Prussia, PA, USA.
Vincent BauchauGSK, 20 Fleming Avenue, 1300, Wavre, Belgium.
Vivek ShindeGSK, 20 Fleming Avenue, 1300, Wavre, Belgium.
Dominique M BarbeauID Biomedical Corporation of Quebec, dba GSK, 245 Armand-Frappier, Laval, QC, Canada.
Catherine CohetGSK, 20 Fleming Avenue, 1300, Wavre, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe investigated a signal of solid organ transplant (SOT) rejection after immunisation with (AS03) A/H1N1 2009 pandemic influenza vaccines.

methodsPotential immunological mechanisms were reviewed and quantitative analyses were conducted. The feasibility of pharmacoepidemiological studies was explored.

resultsOverall results, including data from a pharmacoepidemiological study, support the safety of adjuvanted (AS03) pandemic influenza vaccination in SOT recipients. The regulatory commitment to evaluate the signal through a stepwise investigation was closed in 2014.

conclusionLessons learned highlight the importance of investigating plausible biological mechanisms between vaccines and potentially associated adverse outcomes, and the importance of selecting appropriate study settings and designs for safety signal investigations.

Indexed as

AdolescentAdultAgedalpha-TocopherolAnimalsDrug CombinationsFemaleGraft RejectionHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiceMiddle AgedPharmacoepidemiologyalpha-TocopherolarepanrixAS03 adjuvantDrug CombinationsInfluenza VaccinespandemrixPolysorbatesSqualene

Identifiers

PMID28417321
PMCPMC5519647

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.