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

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Despite 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. Methods: This 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. Results: Data 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. Conclusions: Influenza 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 registration: EudraCT no. 2013-001231-51.
Original languageEnglish
Article number308
JournalBMC Infectious Diseases
Volume19
Issue number1
DOIs
Publication statusPublished - 4 Apr 2019

Cite this

el Guerche-Séblain, Clotilde ; Moureau, Annick ; Schiffler, Camille ; Dupuy, Martin ; Pepin, Stephanie ; Samson, Sandrine I. ; Vanhems, Philippe ; Schellevis, François. / 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. In: BMC Infectious Diseases. 2019 ; Vol. 19, No. 1.
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title = "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",
abstract = "Background: Despite 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. Methods: This 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. Results: Data 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. Conclusions: Influenza 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 registration: EudraCT no. 2013-001231-51.",
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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. / el Guerche-Séblain, Clotilde; Moureau, Annick; Schiffler, Camille; Dupuy, Martin; Pepin, Stephanie; Samson, Sandrine I.; Vanhems, Philippe; Schellevis, François.

In: BMC Infectious Diseases, Vol. 19, No. 1, 308, 04.04.2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - el Guerche-Séblain, Clotilde

AU - Moureau, Annick

AU - Schiffler, Camille

AU - Dupuy, Martin

AU - Pepin, Stephanie

AU - Samson, Sandrine I.

AU - Vanhems, Philippe

AU - Schellevis, François

PY - 2019/4/4

Y1 - 2019/4/4

N2 - Background: Despite 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. Methods: This 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. Results: Data 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. Conclusions: Influenza 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 registration: EudraCT no. 2013-001231-51.

AB - Background: Despite 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. Methods: This 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. Results: Data 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. Conclusions: Influenza 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 registration: EudraCT no. 2013-001231-51.

KW - Acute lower respiratory infection

KW - Acute otitis media

KW - Antibiotic use

KW - Children

KW - Clinical trial

KW - Epidemiology

KW - Fever

KW - Hospitalisation

KW - Influenza

KW - Pneumonia

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UR - https://www.ncbi.nlm.nih.gov/pubmed/30947693

U2 - 10.1186/s12879-019-3920-8

DO - 10.1186/s12879-019-3920-8

M3 - Article

VL - 19

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

SN - 1471-2334

IS - 1

M1 - 308

ER -