Evidence map›Paper›PMID 23061976›Full record

Trial reportInfluenza and other respiratory viruses2013

Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study*.

Eric A Sheldon, Robert Jeanfreau, Joseph A Sliman, Supoat Charenkavanich, Matthew D Rousculp, Filip Dubovsky, Raburn M Mallory

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Influenza and other respiratory viruses, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00952705 (A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 Years of Age), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 43% 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.

NCT00952705 phase3completednot on this map

A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 Years of Age

TypeinterventionalSponsorMedImmune LLCRan2009 to 2010Enrolled1,800ConditionsHealthy or Stable Underlying Chronic Medical ConditionArmsQ/LAIV-BFS (MEDI8662), FluMist/B/Yamagata, FluMist/B/Victoria
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
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  8. Review
  9. Review
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

7 authors at 5 institutions in 2 countries.

Eric A SheldonRheumatology and Internal Medicine, Miami Research Associates, Miami, FL, USAInternal Medicine, Benchmark Research, Metairie, LA, USAVanda Pharmaceuticals, Inc., Washington, DC, USAi3Statprobe, Clarksburg, MD, USAComparative Effectiveness Research, GlaxoSmithKline, Research Triangle Park, NC, USAClinical Development, MedImmune, LLC, Gaithersburg, MD, USA.
Robert Jeanfreau
Joseph A Sliman
Supoat Charenkavanich
Matthew D Rousculp
Filip Dubovsky
Raburn M Mallory
Altimmune (United States) · USResearch Triangle Park Foundation · USBenchmark Research (United States) · USMinistry of Food Agriculture and Livestock · TRVanda Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfluenza B strains from two distinct lineages (Yamagata and Victoria) have cocirculated over recent years. Current seasonal vaccines contain a single B lineage resulting in frequent mismatches between the vaccine strain and the circulating strain. An Ann Arbor strain quadrivalent live attenuated influenza vaccine (Q/LAIV) containing B strains from both lineages is being developed to address this issue.

objectivesThe goal of this study was to evaluate whether Q/LAIV administered intranasally as a single dose to a single nostril, using a blow-fill-seal (BFS) delivery system had a similar immunogenicity and safety profile compared with the licensed trivalent vaccine delivered using the Accuspray device. PATIENTS/

methodsAdults aged 18-49 years were randomized to receive one intranasal dose of Q/LAIV delivered using a BFS device (Q/LAIV-BFS; n=1202) or one of two trivalent live attenuated influenza vaccines (T/LAIV) containing one of the corresponding B strains (total T/LAIV, n=598). Primary endpoints were the post-vaccination strain-specific serum hemagglutination inhibition antibody geometric mean titers for each strain. Secondary immunogenicity endpoints, safety, and acceptability of the BFS device were also assessed.

resultsQ/LAIV was immunogenically non-inferior to T/LAIV for all four influenza strains. Secondary immunogenicity outcomes were consistent with the primary endpoint. Solicited symptoms and AEs were comparable in both groups. Subjects considered the BFS device to be acceptable.

conclusionsImmune responses to vaccination with Ann Arbor strain Q/LAIV-BFS were non-inferior to those with T/LAIV. Q/LAIV may confer broader protection against seasonal influenza B by targeting both major influenza B lineages.

Indexed as

Administration, IntranasalAdolescentAdultAntibodies, ViralFemaleHemagglutination Inhibition TestsHumansInfluenza VaccinesMaleMiddle AgedVaccinationVaccines, AttenuatedVictoriaYoung AdultAntibodies, ViralInfluenza VaccinesVaccines, AttenuatedImmunogenicityintranasal drug administrationlive attenuated influenza vaccinequadrivalent

Identifiers

PMID23061976
PMCPMC4634268
OpenAlexW1487638205

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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.