Evidence map›Paper›PMID 32580919›Full record

Trial reportVaccine2020

A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children.

Krissy K Moehling, Richard K Zimmerman, Mary Patricia Nowalk, Chyongchiou Jeng Lin, Judith M Martin, John F Alcorn, Michael Susick, Ashley Burroughs, Crystal Holiday, Brendan Flannery and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03614975 (Immunologic Response to Influenza Vaccination in Children and Adolescents), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT03614975 phase4completednot on this map

Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines

TypeinterventionalSponsorRichard Zimmerman MDRan2018 to 2018Enrolled166ConditionsInfluenza, Human, Immune ResponseArmsFlucelvax inactivated influenza vaccine, Fluzone inactivated influenza vaccine
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. 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

11 authors at 2 institutions in 1 country.

Krissy K MoehlingDepartment of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Richard K ZimmermanDepartment of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Mary Patricia NowalkDepartment of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: tnowalk@pitt.edu.
Chyongchiou Jeng LinDepartment of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Judith M MartinDepartment of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA.
John F AlcornDepartment of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA; Department of Immunology, University of Pittsburgh, Pittsburgh, PA, USA.
Michael SusickDepartment of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Ashley BurroughsNational Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.
Crystal HolidayNational Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.
Brendan FlanneryNational Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.
Min Z LevineNational Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.
University of Pittsburgh · USCenters for Disease Control and Prevention · US

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR001857 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2016 to 2025
$129.3M
ACL HHS U01IP001035NCATS NIH HHS UL1 TR001857NCIRD CDC HHS U01 IP001035
6 · The paper itself

Abstract

backgroundCurrent influenza vaccine effectiveness (VE) improvement efforts focus on minimizing egg adaptation mutations during manufacture. This study compared immune response of two FDA-approved quadrivalent inactivated influenza vaccines in an unblinded randomized controlled trial.

methodsParticipants were 144 community dwelling, healthy children/adolescents aged 4-20 years, randomized 1:1 in blocks of 4 to a vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n = 85); or in egg medium (IIV4 [Fluzone ®]; n = 83). Blood was drawn at day 0 prevaccination and at day 28 (19-35 days) post vaccination. Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays against egg-based and cell-based A/H3N2 strains were conducted. The primary outcome measure was seroconversion (day 28/day 0 titer ratio ≥ 4 with day 28 titer ≥ 40). Secondary outcomes were elevated titers (day 28 HI titer ≥ 1:110), geometric mean titers (GMTs) and mean fold rise (MFR) in titers. Outcomes were compared for 74 ccIIV4 recipients and 70 IIV4 recipients, and for those vaccinated and unvaccinated the previous year. Only the HI and MN laboratory analysis team was blinded to group assignment.

resultsIn this racially diverse (81% non-white) group of children with a median age of 14 years, baseline demographics did not differ between vaccine groups. At day 0, half or more in each vaccine group had elevated HI or MN titers. Low seroconversion rates (14%-35%) were found; they did not differ between groups. Among 2018-19 ccIIV4 recipients, those unvaccinated in the previous season showed significantly higher MFR against A/H1N1 and A/H3N2 cell-grown virus than the previously vaccinated. Similar results were found for MFR against B/Victoria among 2018-2019 IIV4 recipients.

conclusionIn mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. CLINICAL TRIALS NO: NCT03614975.

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesAdolescentAdultAntibodies, ViralAntibody FormationChildChild, PreschoolHemagglutination Inhibition TestsHumansInfluenza A Virus, H3N2 SubtypeInfluenza B virusVaccines, InactivatedYoung AdultAntibodies, ViralInfluenza VaccinesVaccines, InactivatedAdolescentsChildrenImmunogenicityInfluenzaRCTVaccine

Identifiers

PMID32580919
PMCPMC7367053
OpenAlexW3036021947

What OpenQuestion holds

Textmetadata
LicenceTDM
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.