Evidence map›Paper›PMID 27609809›Full record

Trial reportThe Journal of infectious diseases2016

Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults.

Anuradha Madan, Nathan Segall, Murdo Ferguson, Louise Frenette, Robin Kroll, Damien Friel, Jyoti Soni, Ping Li, Bruce L Innis, Anne Schuind

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01999842 (An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
5.0field-weighted citation impact, top 4% 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.

NCT01999842 phase1completednot on this map

An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2015Enrolled424ConditionsInfluenzaArmsInvestigational H7N9 vaccine GSK3206641A, Investigational H7N9 vaccine GSK3206640A, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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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

10 authors at 8 institutions in 5 countries.

Anuradha MadanGSK, Collegeville.
Nathan SegallClinical Research Atlanta, Stockbridge, Georgia.
Murdo FergusonColchester Research Group, Truro, Nova Scotia.
Louise FrenetteQT Research, Sherbrooke, Quebec, Canada.
Robin KrollSeattle Women's: Health, Research, Gynecology, University of Washington, Seattle.
Damien FrielGSK Vaccines, Wavre, Belgium.
Jyoti SoniGSK Pharmaceuticals, Bangalore, India.
Ping LiGSK Vaccines, King of Prussia, Pennsylvania.
Bruce L InnisGSK Vaccines, King of Prussia, Pennsylvania.
Anne SchuindGSK Vaccines, King of Prussia, Pennsylvania.
GlaxoSmithKline (United States) · USClinical Research Atlanta · USGlaxoSmithKline (Belgium) · BEGlaxosmithkline (Finland) · FIGlaxoSmithKline (India) · INQ & T Research · CASeattle University · USSterling Research Group (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlmost 700 cases of human infection with avian influenza A/H7N9 have been reported since 2013. Pandemic preparedness strategies include H7N9 vaccine development.

methodsWe evaluated an inactivated H7N9 vaccine in an observer-blind study in healthy adults aged 18-64 years. Participants (420) were randomized to receive 1 of 4 AS03-adjuvanted vaccines (low or medium dose of hemagglutinin with AS03

resultsAll adjuvanted vaccines met regulatory acceptance criteria. In groups receiving adjuvanted formulations, seroconversion rates were ≥85.7%, seroprotection rates ≥91.1%, and geometric mean titers ≥92.9% versus 23.2%, 28.6%, and 17.2 for the nonadjuvanted vaccine. The AS03 adjuvant enhanced immune response at antigen-sparing doses. Injection site pain occurred more frequently with adjuvanted vaccines (in ≤98.3% of vaccinees) than with the nonadjuvanted vaccine (40.7%) or placebo (20.0%). None of the 20 serious adverse events reported were related to vaccination.

conclusionsTwo doses of AS03-adjuvanted H7N9 vaccine were well tolerated and induced a robust antibody response at antigen-sparing doses in healthy adults. CLINICAL TRIALS REGISTRATION: NCT01999842.

Indexed as

Adjuvants, ImmunologicAdolescentAdultalpha-TocopherolAntibodies, ViralDrug CombinationsDrug-Related Side Effects and Adverse ReactionsFemaleHealthy VolunteersHumansImmunization ScheduleInfluenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedAdjuvants, Immunologicalpha-TocopherolAntibodies, ViralAS03 adjuvantDrug CombinationsInfluenza VaccinesPlacebosPolysorbatesSqualeneVaccines, Inactivatedadjuvant systemantigen sparingAS03H7N9influenzapandemicvaccine

Identifiers

PMID27609809
PMCPMC5144728
OpenAlexW2513393629

What OpenQuestion holds

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LicenceCC BY
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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.