Evidence map›Paper›PMID 30224199›Full record

Trial reportVaccine2018

Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal.

Aldiouma Diallo, John C Victor, Jodi Feser, Justin R Ortiz, Niranjan Kanesa-Thasan, Moussa Ndiaye, Bou Diarra, Sathie Cheikh, Djibril Diene, Tofene Ndiaye and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01819155 (Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 16% 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.

NCT01819155 phase2completednot on this map

Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal

TypeinterventionalSponsorPATHRan2013 to 2013Enrolled296ConditionsInfluenzaArmsAdjuvanted seasonal trivalent inactivated influenza vaccine, Seasonal trivalent inactivated influenza vaccine, Saline (bacteriostatic 0.9% sodium chloride for injection)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 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

14 authors at 6 institutions in 3 countries.

Aldiouma DialloUMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal. Electronic address: Aldiouma.Diallo@ird.fr.
John C VictorCenter for Vaccine Innovation and Access, PATH, Seattle, USA. Electronic address: jvictor@umich.edu.
Jodi FeserCenter for Vaccine Innovation and Access, PATH, Seattle, USA. Electronic address: jfeser@path.org.
Justin R OrtizCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: jortiz@som.umaryland.edu.
Niranjan Kanesa-ThasanKanesa, LLC, Cambridge, USA.
Moussa NdiayeUMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.
Bou DiarraSenegal Ministry of Health and Social Welfare, Dakar, Senegal.
Sathie CheikhUMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.
Djibril DieneUMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.
Tofene NdiayeUMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal. Electronic address: tofene.ndiaye@ird.fr.
Assane NdiayeUMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal.
Kathryn E LafondInfluenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, USA. Electronic address: gmj3@cdc.gov.
Marc-Alain WiddowsonDivision of Global Health Protection, CDC Kenya, Center for Global Health, Centers for Disease Control and Prevention, Nairobi, Kenya; Division of Global Health Protection, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, USA. Electronic address: zux5@cdc.gov.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: kneuzil@som.umaryland.edu.
Institut de Recherche pour le Développement · SNSeattle University · USUniversity of Maryland, Baltimore · USCenters for Disease Control and Prevention · KECenters for Disease Control and Prevention · USKaneka (United States) · US

Funding

Seasonal Influenza Vaccine Effectiveness in a Tropical Developing African CountryU01IP000476 · IP · PATH · PI VICTOR, JOHN CHRISTIAN · 2011 to 2014
$3.8M
NCIRD CDC HHS U01 IP000476
6 · The paper itself

Abstract

introductionEffective, programmatically suitable influenza vaccines are needed for low-resource countries. MATERIALS AND

methodsThis phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012-2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6-11, 12-35, and 36-71 months. All participants were vaccine-naïve and received two doses of study vaccine 4 weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events.

results296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6-11, 12-35, and 36-71 months receiving TIV had HI titers ≥1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6-11, 12-35, and 36-71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5-38.4 °C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo.

conclusionsBoth aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6-71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.

Indexed as

Immunogenicity, VaccineAdjuvants, ImmunologicAntibodies, ViralChild, PreschoolFemaleHemagglutination Inhibition TestsHumansInfantInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza, HumanInfluenza VaccinesMalePolysorbatesSenegalSqualeneAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesMF59 oil emulsionPolysorbatesSqualeneVaccines, InactivatedAfricaChildrenImmunogenicityInactivated Influenza vaccineMF59 adjuvantSafety

Identifiers

PMID30224199
PMCPMC6327321
OpenAlexW2890372220

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.