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Clinical presentation of influenza in children 6 to 35 months of age: findings from a randomized clinical trial of inactivated quadrivalent influenza vaccine

Clinical presentation of influenza in children 6 to 35 months of age: findings from a randomized clinical trial of inactivated quadrivalent influenza vaccine
Clinical presentation of influenza in children 6 to 35 months of age: findings from a randomized clinical trial of inactivated quadrivalent influenza vaccine
Background: In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6–35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes. Methods: This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011–2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018). Results: 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44−0.77)]. Furthermore, fever >39°C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39−0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case. Conclusions: In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.
0891-3668
866–872
Danier, J.
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Dbaibo, G.
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Acosta, B.
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Hughes, S.M.
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Izu, A.
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Jackowska, T.
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Lucero, M.
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Montellano, M.
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Danier, J.
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Rivera, L.
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Claeys, C
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Dbaibo, G.
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Kosalarksa, P.
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Zaman, K.
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Acosta, B.
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Amanullah, A.
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Diaz, L.
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Hughes, S.M.
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Izu, A.
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Jackowska, T.
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Kant, S.
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Lucero, M.
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Mares Bermudez, J.
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Martinon-Torres, F.
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Montellano, M.
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Prymula, R.
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Puthanakit, T.
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Ruzkova, R.
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Sadowska-Krawczenko, I.
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Soni, J
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Szymanski, H.
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Ulied, A.
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Schuind, A.
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Danier, J., Rivera, L., Claeys, C, Dbaibo, G., Jain, V.K., Kosalarksa, P., Woo, W., Yanni, E., Zaman, K., Acosta, B., Amanullah, A., Ariza, M., Arroba Basanta, M.L., Bavdekar, Ashish, Carmona, A., Cousin, L., Diaz, L., Diez-Domingo, J, Dinleyici, E.C., Faust, S., Garcia-Sicilia, J., Gomez-Go, G.D., Gonzales, M.L.A., Hacimustafaoglu, M., Hughes, S.M., Izu, A., Jackowska, T., Kant, S., Lucero, M., Mares Bermudez, J., Martinon-Torres, F., Montellano, M., Prymula, R., Puthanakit, T., Ruzkova, R., Sadowska-Krawczenko, I., Soni, J, Szymanski, H., Ulied, A. and Schuind, A. (2019) Clinical presentation of influenza in children 6 to 35 months of age: findings from a randomized clinical trial of inactivated quadrivalent influenza vaccine. Pediatric Infectious Disease Journal, 38 (8), 866–872. (doi:10.1097/INF.0000000000002387).

Record type: Article

Abstract

Background: In an exploratory analysis of an inactivated quadrivalent influenza vaccine (IIV4) trial in children 6–35 months without risk factors for influenza, we evaluated clinical presentation of influenza illness and vaccine impact on health outcomes. Methods: This phase III trial was conducted in 13 geographically diverse countries across 5 influenza seasons (2011–2014). Children were randomized 1:1 to IIV4 or control. Active surveillance was performed for influenza-like episodes (ILE); influenza was confirmed by reverse transcription polymerase chain reaction (RT-PCR). The total vaccinated cohort was evaluated (N = 12,018). Results: 5702 children experienced ≥1 ILE; 356 (IIV4 group) and 693 (control group) children had RT-PCR-confirmed influenza. Prevalence of ILE was similar in RT-PCR-positive and RT-PCR-negative cases regardless of vaccination. Breakthrough influenza illness was attenuated in children vaccinated with IIV4; moderate-to-severe illness was 41% less likely to be reported in the IIV4 group than the control group [crude odds ratio: 0.59 (95% confidence intervals: 0.44−0.77)]. Furthermore, fever >39°C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio: 0.54 (95% confidence intervals: 0.39−0.75)] in children with breakthrough illness. Health outcome analysis showed that, each year, IIV4 would prevent 54 influenza cases per 1000 children and 19 children would need to be vaccinated to prevent 1 new influenza case. Conclusions: In addition to preventing influenza in 50% of participants, IIV4 attenuated illness severity and disease burden in children who had a breakthrough influenza episode despite vaccination.

Text
D-QIV-004 clin pres_resubmitted version 2 - Accepted Manuscript
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Accepted/In Press date: 12 April 2019
Published date: August 2019

Identifiers

Local EPrints ID: 430640
URI: http://eprints.soton.ac.uk/id/eprint/430640
ISSN: 0891-3668
PURE UUID: eecc75cc-e987-4cad-bef1-3202dd974640
ORCID for S. Faust: ORCID iD orcid.org/0000-0003-3410-7642

Catalogue record

Date deposited: 07 May 2019 16:30
Last modified: 22 Nov 2021 07:21

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Contributors

Author: J. Danier
Author: L. Rivera
Author: C Claeys
Author: G. Dbaibo
Author: V.K. Jain
Author: P. Kosalarksa
Author: W. Woo
Author: E. Yanni
Author: K. Zaman
Author: B. Acosta
Author: A. Amanullah
Author: M. Ariza
Author: M.L. Arroba Basanta
Author: Ashish Bavdekar
Author: A. Carmona
Author: L. Cousin
Author: L. Diaz
Author: J Diez-Domingo
Author: E.C. Dinleyici
Author: S. Faust ORCID iD
Author: J. Garcia-Sicilia
Author: G.D. Gomez-Go
Author: M.L.A. Gonzales
Author: M. Hacimustafaoglu
Author: S.M. Hughes
Author: A. Izu
Author: T. Jackowska
Author: S. Kant
Author: M. Lucero
Author: J. Mares Bermudez
Author: F. Martinon-Torres
Author: M. Montellano
Author: R. Prymula
Author: T. Puthanakit
Author: R. Ruzkova
Author: I. Sadowska-Krawczenko
Author: J Soni
Author: H. Szymanski
Author: A. Ulied
Author: A. Schuind

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