Evidence map›Paper›PMID 23470848›Full record

Trial reportThe Journal of infectious diseases2013

A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years.

Joseph B Domachowske, Heidemarie Pankow-Culot, Milagros Bautista, Yang Feng, Carine Claeys, Mathieu Peeters, Bruce L Innis, Varsha Jain

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01196988 (Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
11.0field-weighted citation impact, top 1% 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.

NCT01196988 phase3completednot on this map

Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2011Enrolled3,027ConditionsInfluenzaArmsInfluenza vaccine GSK2321138A, FluarixTM, Influenza vaccine GSK2604409A
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 103 citations in OpenAlex.

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  10. Immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine: a Phase III, open-label study of adults in Brazil.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
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  20. [The universal influenza vaccination in children with Vaxigrip TetraJournal of preventive medicine and hygiene · 2018
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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

8 authors at 5 institutions in 5 countries.

Joseph B DomachowskeDepartment of Pediatrics, Golisano Children's Hospital, Upstate Medical University, Syracuse, New York 13210, USA. domachoj@upstate.edu
Heidemarie Pankow-Culot
Milagros Bautista
Yang Feng
Carine Claeys
Mathieu Peeters
Bruce L Innis
Varsha Jain
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (Belgium) · BEHospital zum Heiligen Geist · DESUNY Upstate Medical University · USUniversity of the East Ramon Magsaysay Memorial Medical Center · PH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTwo antigenically distinct influenza B lineages have cocirculated since 2001, yet trivalent influenza vaccines (TIVs) contain 1 influenza B antigen, meaning lineage mismatch with the vaccine is frequent. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages vs TIV in healthy children aged 3-17 years.

methodsChildren were randomized 1:1:1 to receive QIV or 1 of 2 TIVs (either B/Victoria or B/Yamagata lineage; N = 2738). Hemagglutination-inhibition assays were performed 28 days after 1 or 2 doses in primed and unprimed children, respectively. Immunological noninferiority of QIV vs TIV against shared strains, and superiority against alternate-lineage B strains was based on geometric mean titers (GMTs) and seroconversion rates. Reactogenicity and safety were also assessed (Clinicaltrials.gov NCT01196988).

resultsNoninferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV vs TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.

conclusionsQIV vs TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines.

Indexed as

AdolescentAntibodies, ViralChildChild, PreschoolCohort StudiesDouble-Blind MethodEuropeFemaleHemagglutination Inhibition TestsHIV SeropositivityHumansInfantInfluenza A virusInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusAntibodies, ViralInfluenza VaccinesVaccines, Inactivatednoninferioritypediatricquadrivalentseasonal influenzasuperioritytrivalent

Identifiers

PMID23470848
PMCPMC3654742
OpenAlexW2115920014

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.