Evidence map›Paper›PMID 22267719›Full record

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

H1N1 antibody persistence 1 year after immunization with an adjuvanted or whole-virion pandemic vaccine and immunogenicity and reactogenicity of subsequent seasonal influenza vaccine: a multicenter follow-on study.

Woolf T Walker, Philip de Whalley, Nick Andrews, Clarissa Oeser, Michelle Casey, Louise Michaelis, Katja Hoschler, Caroline Harrill, Phoebe Moulsdale, Ben Thompson and 13 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter Study
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 NCT01239537 (A Multi-centre, Open-label, Clinical, Phase 4 Trial, Following on From a Head-to-head Comparison Study of Two H1N1 Influenza Vaccines in Children, to Compare Firstly, the Persistence of Antibody Against the A/California/7/2009), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
4.5field-weighted citation impact, top 5% 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.

NCT01239537 completednot on this map

A Multi-centre, Open-label, Clinical, Phase 4 Trial, Following on From a Head-to-head Comparison Study of Two H1N1 Influenza Vaccines in Children, to Compare Firstly, the Persistence of Antibody Against the A/California/7/2009 (H1N1) Virus and Secondly the Immunogenicity and Reactogenicity of One Dose of a Non-adjuvanted Trivalent Seasonal Influenza Vaccine, in Children Who Had Received a Two-dose Immunisation Regimen of Celvapan or Pandemrix.

TypeobservationalSponsorUniversity of OxfordRan2010 to 2010Enrolled560ConditionsInfluenzaArmsSeasonal Flu vaccine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. 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

23 authors at 7 institutions in 2 countries.

Woolf T WalkerSouthampton NIHR Wellcome Trust Clinical Research Facility, Faculty of Medicine, University of Southampton, United Kingdom.
Philip de Whalley
Nick Andrews
Clarissa Oeser
Michelle Casey
Louise Michaelis
Katja Hoschler
Caroline Harrill
Phoebe Moulsdale
Ben Thompson
Claire Jones
Jem Chalk
Simon Kerridge
Tessa M John
Ifeanyichukwu Okike
Shamez Ladhani
Richard Tomlinson
Paul T Heath
Elizabeth Miller
Saul N Faust
Matthew D Snape
Adam Finn
Andrew J Pollard
University of Oxford · GBSt George's, University of London · GBHealth Protection Agency · MVNIHR Southampton Respiratory Biomedical Research Unit · GBNIHR Wellcome Trust Southampton Clinical Research Facility · GBRoyal Devon & Exeter NHS Foundation Trust · GBUniversity Hospitals Bristol NHS Foundation Trust · GB

Funding

Department of Health 10/111/01
6 · The paper itself

Abstract

backgroundWe investigated antibody persistence in children 1 year after 2 doses of either an AS03(B)-adjuvanted split-virion or nonadjuvanted whole-virion monovalent pandemic influenza vaccine and assessed the immunogenicity and reactogenicity of a subsequent dose of trivalent influenza vaccine (TIV).

methodsChildren previously immunized at age 6 months to 12 years in the original study were invited to participate. After a blood sample was obtained to assess persistence of antibody against swine influenza A/H1N1(2009) pandemic influenza, children received 1 dose of 2010/2011 TIV, reactogenicity data were collected for 7 days, and another blood sample was obtained 21 days after vaccination.

resultsOf 323 children recruited, 302 received TIV. Antibody persistence (defined as microneutralization [MN] titer ≥1:40) 1 year after initial vaccination was significantly higher in the AS03(B)-adjuvanted compared with the whole-virion vaccine group, 100% (95% confidence interval [CI], 94.1%-100%) vs 32.4% (95% CI, 21.5%-44.8%) in children immunized <3 years old and 96.9% (95% CI, 91.3%-99.4%) vs 65.9% (95% CI, 55.3%-75.5%) in those 3-12 years old at immunization, respectively (P < .001 for both groups). All children receiving TIV had post-vaccination MN titers ≥1:40. Although TIV was well tolerated in all groups, reactogenicity in children <5 years old was slightly greater in those who originally received AS03(B)-adjuvanted vaccine.

conclusionsThis study provides serological evidence that 2 doses of AS03(B)-adjuvanted pandemic influenza vaccine may be sufficient to maintain protection across 2 influenza seasons. Administration of TIV to children who previously received 2 doses of either pandemic influenza vaccine is safe and is immunogenic for the H1N1 strain.

Indexed as

Adjuvants, ImmunologicAntibodies, ViralFollow-Up StudiesHemagglutination Inhibition TestsHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesNeutralization TestsVirionAdjuvants, ImmunologicAntibodies, ViralInfluenza Vaccines

Identifiers

PMID22267719
PMCPMC3275760
OpenAlexW2144025889

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.