Evidence map›Paper›PMID 30947693›Full record

Trial reportBMC infectious diseases2019

Epidemiology and burden of influenza in healthy children aged 6 to 35 months: analysis of data from the placebo arm of a phase III efficacy trial.

Clotilde El Guerche-Séblain, Annick Moureau, Camille Schiffler, Martin Dupuy, Stephanie Pepin, Sandrine I Samson, Philippe Vanhems, François Schellevis

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.4field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

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  11. Influenza A and B in a cohort of outpatient children and adolescent with influenza like-illness during two consecutive influenza seasons.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases
    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

8 authors at 3 institutions in 2 countries.

Clotilde El Guerche-SéblainGlobal Vaccine and Epidemiology Department, Sanofi Pasteur, Lyon, France. Clotilde.ElGuercheSeblain@sanofi.com.ORCID http://orcid.org/0000-0003-0196-4357
Annick MoureauGlobal Clinical Biostatistics Department, Sanofi Pasteur, Marcy l'Étoile, France.
Camille SchifflerGlobal HEOR Department, Sanofi Pasteur, Lyon, France.
Martin DupuyGlobal Biostatistics Department, Sanofi Pasteur, Marcy l'Étoile, France.
Stephanie PepinGlobal Clinical Sciences, Sanofi Pasteur, Marcy l'Étoile, France.
Sandrine I SamsonGlobal Medical Affairs, Sanofi Pasteur, Lyon, France.
Philippe VanhemsEpidemiology and International Health Team, Emergent Pathogens Laboratory, Fondation Mérieux, International Center for Research in Infectiology, National Institute of Health and Medical Research, U1111, National Center of Scientific Research, Mixed Scientific Unit 5308, École Nationale Supérieure de Lyon, Université Claude Bernard Lyon 1, Lyon, France.
François SchellevisNetherlands Institute for Health Services Research, Utrecht, The Netherlands.
Sanofi (France) · FRNetherlands Institute for Health Services Research · NLUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite World Health Organization recommendations, in many countries young children are not targeted for influenza vaccination. To help inform influenza vaccination policy, we examined the occurrence and burden of influenza in healthy children aged 6 to 35 months using data from a recent phase III placebo-controlled influenza vaccine trial conducted in countries in the Northern and Southern Hemispheres.

methodsThis was an analysis of data from participants included in the placebo arm of a phase III clinical trial in healthy children aged 6 to 35 months (EudraCT no. 2013-001231-51). Included children had never been vaccinated for influenza and were observed for one influenza season. Outcome measures included the occurrence of influenza-like illness (ILI), laboratory-confirmed influenza, virus types/subtypes, severe symptoms and complications of confirmed influenza, and healthcare use associated with confirmed influenza.

resultsData from 2210 participants were analysed. ILI was reported for 811 participants (36.7%). Of these, 255 participants (31.4%) had 263 virologically confirmed episodes of influenza. The overall influenza attack rate was 11.5%. The most common influenza virus detected was A(H3N2) (40.7%), followed by B/Yamagata (23.6%), A(H1N1) (18.6%), and B/Victoria (8.0%). Grade 3 fever was reported in 24.3% of confirmed episodes, acute lower respiratory infection in 8.7%, acute otitis media in 6.1%, and pneumonia in 1.9%. In most influenza episodes (93.2%), antipyretics, analgesics, or non-steroidal anti-inflammatory drugs were taken. Antibiotics were prescribed for 41.4% of influenza episodes. More than half of the influenza episodes (57.0%) resulted in outpatient visits. Influenza resulted in overnight hospitalisation in 1.1% of episodes.

conclusionsInfluenza is associated with a significant burden of disease in healthy children. This analysis also revealed that antibiotics continue to be frequently used for young children with influenza.

trial registrationEudraCT no. 2013-001231-51 .

Indexed as

Outcome Assessment, Health CareAnti-Bacterial AgentsAntipyreticsChild, PreschoolCost of IllnessFemaleHumansInfantInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza, HumanInfluenza VaccinesMalePlacebo EffectRespiratory Tract InfectionsRNA, ViralAnti-Bacterial AgentsAntipyreticsInfluenza VaccinesRNA, ViralAcute lower respiratory infectionAcute otitis mediaAntibiotic useChildrenClinical trialEpidemiologyFeverHospitalisationInfluenzaPneumonia

Identifiers

PMID30947693
PMCPMC6449994
OpenAlexW2944731372

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.