Evidence map›Paper›PMID 21668683›Full record

Trial reportInfluenza and other respiratory viruses2011

An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2-17 years.

Christopher S Ambrose, Tingting Yi, Judith Falloon

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Influenza and other respiratory viruses, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
4.4field-weighted citation impact, top 6% 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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Vaccines for preventing influenza in healthy children.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Vaccines for preventing influenza in healthy children.The Cochrane database of systematic reviews · 2012
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. The safety and efficacy of live attenuated influenza vaccine in young children with asthma or prior wheezing.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2012
    Trial
  8. Article
  9. Article
  10. Article
  11. Influenza vaccines: Evaluation of the safety profile.Human vaccines & immunotherapeutics · 2018
    Review
  12. Article
  13. Public health impact and cost-effectiveness of intranasal live attenuated influenza vaccination of children in Germany.The European journal of health economics : HEPAC : health economics in prevention and care · 2015
    Article
  14. Article
  15. 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

3 authors at 1 institution in 1 country.

Christopher S AmbroseMedImmune LLC, Gaithersburg, MD, USA. ambrosec@medimmune.com
Tingting Yi
Judith Falloon
Amplimmune (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrivalent, Ann Arbor strain, live attenuated influenza vaccine (LAIV) is approved in several countries for use in eligible children aged ≥2 years.

objectiveTo describe the safety of Ann Arbor strain LAIV in children aged 2-17 years.

methodsAn integrated analysis of randomized, controlled trials of LAIV.

resultsA total of 4245 and 10,693 children received ≥1 dose of LAIV in year 1 of 6 trivalent inactivated influenza vaccine (TIV)-controlled and 14 placebo-controlled studies, respectively; 3212 children were revaccinated in year 2 of 4 placebo-controlled studies. Compared with placebo for days 0-10 post-vaccination, LAIV recipients exhibited increased runny/stuffy nose (+7%), headache (+7%), and tiredness/decreased activity (+2%) after dose 1; and a higher rate of decreased appetite (+4%) after year 2 revaccination. Compared with TIV, only runny/stuffy nose was increased (dose 1, +12%; dose 2, +4%). Compared with initial vaccination, LAIV reactogenicity was lower after dose 2 in year 1 and revaccination in year 2. Unsolicited adverse events (AEs) increased with LAIV in some comparisons were headache, nasal congestion/rhinorrhea, rhinitis, and pyrexia; ear pain and lower respiratory illness were decreased. There was no evidence of an increase in any potential vaccine-related serious AE in LAIV recipients. Among children aged 2-17 years and specifically aged 24-35 months, there was no evidence that lower respiratory illness or wheezing illness occurred at a higher rate in LAIV recipients.

conclusionThis analysis supports the safety of Ann Arbor strain LAIV in children aged 2-17 years and provides a consensus assessment of events expected after vaccination.

Indexed as

AdolescentChildChild, PreschoolFemaleHumansInfluenza, HumanInfluenza VaccinesMaleVaccinationVaccines, AttenuatedInfluenza VaccinesVaccines, Attenuated

Identifiers

PMID21668683
PMCPMC3256242
OpenAlexW1562568586

What OpenQuestion holds

Textmetadata
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.