Evidence map›Paper›PMID 27746224›Full record

Trial reportThe Lancet. Global health2016

Efficacy of a Russian-backbone live attenuated influenza vaccine among children in Senegal: a randomised, double-blind, placebo-controlled trial.

John C Victor, Kristen D C Lewis, Aldiouma Diallo, Mbayame N Niang, Bou Diarra, Ndongo Dia, Justin R Ortiz, Marc-Alain Widdowson, Jodi Feser, Rebecca Hoagland and 3 more

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

Trial report in The Lancet. Global health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01854632 (A Randomized, Double-Blind, Placebo-Controlled Trial of the Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
9.8field-weighted citation impact, top 1% 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.

NCT01854632 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Trial of the Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

TypeinterventionalSponsorPATHRan2013 to 2013Enrolled1,761ConditionsInfluenzaArmsSIIL Live Attenuated Influenza Vaccine, Matched placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Review
  17. Iron, Hepcidin, and Immunity.Advances in experimental medicine and biology · 2025
    Review
  18. Review
  19. Live Attenuated Cold-Adapted Influenza Vaccines.Cold Spring Harbor perspectives in medicine · 2021
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

John C VictorPATH, Seattle, WA, USA. Electronic address: cvictor@path.org.
Kristen D C LewisPATH, Seattle, WA, USA.
Aldiouma DialloMixed Research Unit 198, Institut de Recherche Pour le Développement, Dakar, Senegal.
Mbayame N NiangSenegal National Influenza Center, Institut Pasteur de Dakar, Dakar, Senegal.
Bou DiarraMixed Research Unit 198, Institut de Recherche Pour le Développement, Dakar, Senegal.
Ndongo DiaSenegal National Influenza Center, Institut Pasteur de Dakar, Dakar, Senegal.
Justin R OrtizPATH, Seattle, WA, USA; Departments of Global Health and Medicine, University of Washington, Seattle, WA, USA.
Marc-Alain WiddowsonInfluenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jodi FeserPATH, Seattle, WA, USA.
Rebecca HoaglandCota Enterprises Inc, McLouth, KS, USA.
Shannon L EmeryInfluenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Kathryn E LafondInfluenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Kathleen M NeuzilCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.
Program for Appropriate Technology in Health · USInstitut de Recherche pour le Développement · SNInstitut Pasteur de Dakar · SNNational Center for Immunization and Respiratory Diseases · USCenters for Disease Control and Prevention · USUniversity of Maryland, Baltimore · USUniversity of Washington · 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

backgroundLive attenuated influenza vaccines have been shown to significantly reduce influenza in diverse populations of children, but no efficacy studies have been done in resource-poor tropical settings. In Senegal, we assessed the efficacy and safety of a live attenuated influenza vaccine based on Russian-derived master donor viruses and licensed as a single dose.

methodsIn this double-blind, placebo-controlled, parallel group, single-centre trial done near Niakhar, Senegal, generally healthy children aged 2-5 years were randomly allocated (2:1) to receive a single intranasal dose of masked trivalent live attenuated influenza vaccine or placebo. The allocation sequence was computer-generated by PATH with block sizes of three. The manufacturer provided vaccine and placebo in coded vials to preserve blinding. Participants were monitored through the predictable influenza season in Senegal for adverse events and signs and symptoms of influenza using weekly home visits and surveillance in clinics. The primary outcome was symptomatic laboratory-confirmed influenza caused by any strain and occurring from 15 days post-vaccination to the end of the study. The primary analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT01854632.

findingsBetween May 23, and July 1, 2013, 1761 children were randomly assigned, 1174 to receive live attenuated influenza vaccine and 587 to receive placebo. The per-protocol set included 1173 vaccinees and 584 placebo recipients followed up to Dec 20, 2013. Symptomatic influenza was laboratory-confirmed in 210 (18%) of 1173 recipients of live attenuated influenza vaccine and 105 (18%) of placebo recipients, giving a vaccine efficacy of 0·0% (95% CI -26·4 to 20·9). Adverse events were balanced between the study groups. Two girls who had received live attenuated influenza vaccine died, one due to anasarca 12 days postvaccination and one due to malnutrition 70 days postvaccination.

interpretationLive attenuated influenza vaccine was well tolerated in young children in Senegal, but did not provide protection against influenza. Further study in such populations, which might experience extended periods of influenza circulation, is warranted.

fundingUS Centers for Disease Control and Prevention and Bill & Melinda Gates Foundation.

Indexed as

Administration, IntranasalChild, PreschoolDouble-Blind MethodFemaleHumansInfantInfluenza, HumanInfluenza VaccinesMaleSenegalVaccinationVaccines, AttenuatedInfluenza VaccinesVaccines, Attenuated

Identifiers

PMID27746224
PMCPMC5118222
OpenAlexW2530113419

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.