Evidence map›Paper›PMID 29446176›Full record

ArticlePharmacoepidemiology and drug safety2018

Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method.

Rongxia Li, Eric Weintraub, Michael M McNeil, Martin Kulldorff, Edwin M Lewis, Jennifer Nelson, Stanley Xu, Lei Qian, Nicola P Klein, Frank Destefano

Open access · greenAbstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 12% 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.

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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Guideline
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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 4 institutions in 2 countries.

Rongxia LiImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0000-0003-0664-4803
Eric WeintraubImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Michael M McNeilImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Martin KulldorffDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
Edwin M LewisKaiser Permanente Vaccine Study Center, Oakland, CA, USA.
Jennifer NelsonGroup Health Research Institute and University of Washington, Seattle, WA, USA.
Stanley XuInstitute for Health Research, Kaiser Permanente, Denver, CO, USA.
Lei QianSouthern California Kaiser Permanente, Pasadena, CA, USA.
Nicola P KleinKaiser Permanente Vaccine Study Center, Oakland, CA, USA.
Frank DestefanoImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Centers for Disease Control and Prevention · USKaiser Permanente · USBrigham and Women's Hospital · USGroup Health Cooperative · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

purposeThe objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a large distributed safety data setting.

methodsTraditional pharmacovigilance techniques used in vaccine safety are generally geared to detecting AEs based on pre-defined sets of conditions or diagnoses. Using a newly developed tree-temporal scan statistic data mining method, we performed a pilot study to evaluate the safety profile of the meningococcal conjugate vaccine Menactra® (MenACWY-D), screening thousands of potential AE diagnoses and diagnosis groupings. The study cohort included enrolled participants in the Vaccine Safety Datalink aged 11 to 18 years who had received MenACWY-D vaccination(s) between 2005 and 2014. The tree-temporal scan statistic was employed to identify statistical associations (signals) of AEs following MENACWY-D at a 0.05 level of significance, adjusted for multiple testing.

resultsWe detected signals for 2 groups of outcomes: diseases of the skin and subcutaneous tissue, fever, and urticaria. Both groups are known AEs following MENACWY-D vaccination. We also identified a statistical signal for pleurisy, but further examination suggested it was likely a false signal. No new MENACWY-D safety concerns were raised.

conclusionsAs a pilot study, we demonstrated that the tree-temporal scan statistic data mining method can be successfully applied to screen broadly for a wide range of vaccine-AE associations within a large health care data network.

Indexed as

PharmacovigilanceAdolescentChildCohort StudiesDatabases, FactualData MiningElectronic Health RecordsFemaleHumansMaleMeningococcal VaccinesPilot ProjectsSoftwareVaccinationMenACWY-D vaccineMeningococcal Vaccinesadverse eventsBell's palsyMenactrapharmacoepidemiologypost-licensure

Identifiers

PMID29446176
PMCPMC10878474
OpenAlexW2792672589

What OpenQuestion holds

Textmetadata
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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.