Evidence map›Paper›PMID 30325891›Full record

Trial reportThe Pediatric infectious disease journal2019

Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naïve Children.

Carine Claeys, Vijayalakshmi Chandrasekaran, José García-Sicilia, Roman Prymula, Javier Díez-Domingo, Jerzy Brzostek, Josep Marès-Bermúdez, Federico Martinón-Torres, Andrew J Pollard, Renata Růžková and 12 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Pediatric infectious disease journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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.

NCT01439360 phase3completednot on this map

An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children

TypeinterventionalSponsorGlaxoSmithKlineRan2011 to 2014Enrolled12,046ConditionsInfluenzaArmsQuadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior, Prevenar 13, Varivax/ProVarivax, Varilrix
NCT01702454 phase3completednot on this map

Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2013Enrolled470ConditionsInfluenzaArmsFluarix Quadrivalent
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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

22 authors at 14 institutions in 7 countries.

Carine ClaeysFrom the GSK, Wavre, Belgium.
Vijayalakshmi ChandrasekaranGSK, King of Prussia, Pennsylvania.
José García-SiciliaHospital Materno-Infantil La Paz, Madrid, Spain.
Roman PrymulaFaculty of Medicine, University Hospital and Charles University, Hradec Králové, Czech Republic.
Javier Díez-DomingoVaccine Research Department, FISABIO-Public Health, Valencia, Spain.
Jerzy BrzostekInfectious Diseases Outpatient Clinic, Debica, Poland.
Josep Marès-BermúdezInstitut Pediàtric Marès-Riera, Girona, Spain.
Federico Martinón-TorresTranslational Pediatrics and Infectious Diseases, Department of Pediatrics, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Galicia, Spain.
Andrew J PollardUniversity of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.
Renata RůžkováPediatric Office Dr. Renáta Růžková, Prague, Czech Republic.
Alfonso Carmona MartinezInstituto Hispalense de Pediatría, Sevilla, Spain.
Angels UliedCAP Centelles, Barcelona, Spain.
Mariano Miranda ValdiviesoHospital de Antequera, Málaga, Spain.
Saul N FaustNational Institute of Health Research Wellcome Trust Clinical Research Facility, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Matthew D SnapeUniversity of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.
Damien FrielFrom the GSK, Wavre, Belgium.
Thierry OllingerFrom the GSK, Wavre, Belgium.
Jyoti SoniGSK, Bangalore, India.
Anne SchuindGSK, Rockville, Maryland.
Ping LiGSK, King of Prussia, Pennsylvania.
Bruce L InnisGSK, King of Prussia, Pennsylvania.
Varsha K JainGSK, King of Prussia, Pennsylvania.
GlaxoSmithKline (Belgium) · BE1 Military Clinical Hospital with Outpatient Clinic · PLCharles University · CZConsorci d’Atenció Primària de Salut Barcelona Esquerra · ESFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESGlaxoSmithKline (India) · INGlaxoSmithKline (United States) · USHospital Materno-Infantil · ESHospital Regional Universitario de Málaga · ESInstituto de Investigación Sanitaria de Santiago · ESInstituto Hispalense de Pediatria · ESOxford BioMedica (United Kingdom) · GBUniversity of Oxford · GBWellcome Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt has not yet been demonstrated whether 2 doses of inactivated quadrivalent influenza vaccine (IIV4) prime a booster response in infants. We evaluated the anamnestic immune response to an IIV4 in children 17-48 months of age.

methodsChildren were randomized to 2 doses of IIV4 or control in the primary phase III study (NCT01439360). One year later, in an open-label revaccination extension study (NCT01702454), a subset of children who received IIV4 in the primary study (primed group) received 1 IIV4 dose and children who received control in the primary study (unprimed) received 2 IIV4 doses 28 days apart. The primary objective was to evaluate hemagglutination inhibition (HI) antibody titers 7 days after first IIV4 vaccination in the per-protocol cohort (N = 224 primed; N = 209 unprimed). Neutralizing and antineuraminidase antibodies were also measured. Safety was analyzed in the total vaccinated cohort (N = 241 primed; N = 229 unprimed).

resultsAn anamnestic response was observed in primed children relative to unprimed controls, measured by age-adjusted geometric mean HI titer ratios against strains homologous (A/H1N1: 9.0; B/Victoria: 3.9) and heterologous (A/H3N2: 2.7; B/Yamagata: 6.7) to those in the primary vaccination series. The anamnestic response in primed children included increases in neutralizing antibodies (mean geometric increase: 5.0-10.6) and antineuraminidase antibodies (4.9-8.8). No serious adverse events related to vaccination were reported.

conclusionsIn this study, 2-dose priming with IIV4 induced immune memory that was recalled with 1-dose IIV4 the following year to boost HI, antineuraminidase and neutralizing antibodies, even though the IIV4 strain composition partially changed.

Indexed as

Immunologic MemoryAntibodies, NeutralizingAntibodies, ViralChild, PreschoolDrug-Related Side Effects and Adverse ReactionsFemaleHemagglutination Inhibition TestsHumansInfantInfluenza, HumanInfluenza VaccinesMaleNeutralization TestsVaccines, InactivatedAntibodies, NeutralizingAntibodies, ViralInfluenza VaccinesVaccines, Inactivated

Identifiers

PMID30325891
PMCPMC6344072
OpenAlexW2895874893

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.