Evidence map›Paper›PMID 30530581›Full record

ArticleBMJ open2018

Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research Datalink.

Herve Caspard, Amy Steffey, Raburn M Mallory, Christopher S Ambrose

Erratum issuedOpen access · goldAbstract readEvaluation Study
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Herve CaspardDepartment of Medical Affairs, MedImmune/AstraZeneca, Gaithersburg, Maryland, USA.
Amy SteffeyDepartment of Medical Affairs, MedImmune/AstraZeneca, Gaithersburg, Maryland, USA.
Raburn M MalloryDepartment of Medical Affairs, MedImmune/AstraZeneca, Gaithersburg, Maryland, USA.
Christopher S AmbroseDepartment of Medical Affairs, MedImmune/AstraZeneca, Gaithersburg, Maryland, USA.
AstraZeneca (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.

designNon-interventional cohort study.

settingEngland during 2013-2014 and 2014-2015 influenza seasons.

participantsLAIV recipients identified from the Clinical Practice Research Datalink, aged 2-17 years, and with at least one underlying high-risk condition. LAIV recipients were matched with inactivated influenza vaccine (IIV) recipients and unvaccinated controls. PRIMARY OUTCOME MEASURES: Primary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.

results11 463 children and adolescents were included: 4718 received the trivalent LAIV formulation during the 2013-2014 influenza season and 6745 received the quadrivalent formulation during the 2014-2015 influenza season. The risks of hospitalisation within 42 days were 231 per 1000 person-years (95% CI 193 to 275) in season 2013-2014 and 231 (95% CI 198 to 267) in season 2014-2015. These risks were not significantly different when compared with matched unvaccinated children (relative risks (RR) 0.96 (95% CI 0.78 to 1.19) in season 2013-2014, 0.90 (95% CI 0.76 to 1.07) in season 2014-2015) and consistently lower than after IIV administration (RR 0.47 (95% CI: 0.37 to 0.59) in season 2013-2014, 0.42 (95% CI 0.35 to 0.51) in season 2014-2015). A similar pattern was observed up to 6 months postvaccination with a risk of hospitalisation after LAIV administration that did not differ from what was observed in unvaccinated controls and was lower than after IIV administration.

conclusionsThis study did not identify new safety concerns associated with the administration of LAIV in children and adolescents with high-risk conditions. However, as with any other observational study, treatment administration was not randomly assigned and our findings may be confounded by differences between the groups at baseline. TRIAL REGISTRATION NUMBER: EUPAS18527.

Indexed as

AdolescentAsthmaChildChild, PreschoolCohort StudiesEnglandFemaleHospitalizationHumansInfluenza, HumanInfluenza VaccinesMaleRisk FactorsVaccines, AttenuatedInfluenza VaccinesVaccines, Attenuatedhigh-risk conditionshospitalizationlive attenuated influenza vaccinepaediatricspost-licensure safety

Identifiers

PMID30530581
PMCPMC6292422
OpenAlexW2904281892

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.