Evidence map›Paper›PMID 23856331›Full record

Trial reportVaccine2013

Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: an observer-blind, randomized trial.

William H Yang, Marc Dionne, Michael Kyle, Naresh Aggarwal, Ping Li, Miguel Madariaga, Olivier Godeaux, David W Vaughn

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00979602 (A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
3.3field-weighted citation impact, top 8% 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.

NCT00979602 phase3completednot on this map

A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2011Enrolled4,048ConditionsInfluenzaArmsGSK2340274A, GSK2340273A
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 38 citations in OpenAlex.

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  20. Adjuvanted influenza vaccines.Human vaccines & immunotherapeutics · 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 4 institutions in 2 countries.

William H YangAllergy and Asthma Research Center and University of Ottawa Medical School, Ottawa, ON, Canada. wyang@yangmedicine.com
Marc Dionne
Michael Kyle
Naresh Aggarwal
Ping Li
Miguel Madariaga
Olivier Godeaux
David W Vaughn
GlaxoSmithKline (United States) · USCentre hospitalier universitaire de Québec · CARadiant Research (United States) · USUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study (NCT00979602) evaluated the immunogenicity and relative protective efficacy of one dose of influenza A(H1N1)pdm09 vaccine with or without AS03 (an α-tocopherol oil-in-water emulsion based Adjuvant System).

methodsFour thousands and forty-eight healthy adults aged ≥ 18 years were randomized (1:1) to receive one dose of either the adjuvanted split virion (3.75 μg hemagglutinin antigen [HA]/AS03) or non-adjuvanted (15 μg HA) vaccine. Hemagglutination inhibition [HI] antibody response was evaluated before vaccination and at Days 21, 42 and 182 (Month 6). Safety of the study vaccines was evaluated during the entire study duration.

resultsAt Day 21, both study vaccines induced HI immune responses meeting the US regulatory criteria in subjects 18-64 years (seroprotection rate [SPR]: 98.0% [97.1-98.6]; seroconversion rate [SCR]: 89.7% [88.0-91.2] in the AS03-adjuvanted group; SPR: 91.4% [89.9-92.8]; SCR: 74.6% [72.3-76.9] in the non-adjuvanted group) and >64 years of age (SPR: 86.0% [82.5-89.0]; SCR: 75.3% [71.1-79.2] in the AS03-adjuvanted group; SPR: 69.1% [64.6-73.3]; SCR: 56.7% [52.0-61.3] in the non-adjuvanted group). The AS03-adjuvanted vaccine induced higher HI geometric mean titers than the non-adjuvanted vaccine at all time points. At Month 6, only subjects 18-64 years of age from both vaccine groups still met the US regulatory criteria (SPR: 82.1% [80.0-84.1]; SCR: 62.3% [59.6-64.8] in the AS03-adjuvanted group; SPR: 75.3% [72.9-77.5]; SCR: 53.7% [51.0-56.4] in the non-adjuvanted group). Protective efficacy was not evaluated due to low number of RT-qPCR-confirmed A(H1N1)pdm09 influenza cases. Through Month 12, 216 serious adverse events (in 157 subjects: 84 in the AS03-adjuvanted and 73 in the non-adjuvanted group) and 12 potentially immune mediated diseases (5 in the AS03-adjuvanted and 7 in the non-adjuvanted group) were reported.

conclusionA single dose of either adjuvanted or non-adjuvanted influenza A(H1N1)pdm09 vaccine induced protective HI antibody levels against the A/California/7/2009 strain that persisted through Month 6 in the 18-64 years population.

Indexed as

Adjuvants, ImmunologicAdolescentAdultalpha-TocopherolAntibodies, ViralAntibody FormationDrug CombinationsHemagglutination Inhibition TestsHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesMiddle AgedPolysorbatesSqualeneVaccinationAdjuvants, Immunologicalpha-TocopherolAntibodies, ViralAS03 adjuvantDrug CombinationsInfluenza VaccinesPolysorbatesSqualeneaccording to protocolAdjuvantATPBARDABiomedical Advanced Research and Development AuthorityBMIbody mass indexCBERCenter for Biologics Evaluation & ResearchCHMPCICommittee for Medicinal Products for Human Useconfidence intervalgeometric mean fold risegeometric mean titerGMFRGMTH1N1HAhemagglutination inhibitionhemagglutininHHSHIILIsInfluenzaInfluenza-Like-IllnessesPandemicpIMDspotential immune mediated diseasesrespiratory viral panelRVPSAEsSCRSDserious adverse eventsseroconversion rateseroprotection rateSPRstandard deviationtotal vaccinated cohortTVCUnited States Department of Health and Human ServicesVaccinevaccine effectiveness improvementVEIWHOWorld Health Organization

Identifiers

PMID23856331
PMCPMC7115432
OpenAlexW2076757133

What OpenQuestion holds

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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.