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Clinical Trial
. 2019 Apr 4;19(1):308.
doi: 10.1186/s12879-019-3920-8.

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  1 , Annick Moureau  2 , Camille Schiffler  3 , Martin Dupuy  4 , Stephanie Pepin  5 , Sandrine I Samson  6 , Philippe Vanhems  7 , François Schellevis  8   9
Affiliations
Clinical Trial

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 et al. BMC Infect Dis. .

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 .

Keywords: Acute lower respiratory infection; Acute otitis media; Antibiotic use; Children; Clinical trial; Epidemiology; Fever; Hospitalisation; Influenza; Pneumonia.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the independent ethics committee or institutional review board for each study site (full details provided in Additional File 3) and was conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. Written informed consent was provided by the parents or legal representatives of all children participating in this trial.

Consent for publication

Not applicable.

Competing interests

C.E.S., A.M., C.S., M.D., S.P., and S.S. are employees of Sanofi Pasteur. F.S. and P.V. declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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