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...

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Published in:	The Pediatric infectious disease journal Vol. 38; no. 8; pp. 866 - 872
Main Authors:	Danier, Jasur, Rivera, Luis, Claeys, Carine, Dbaibo, Ghassan, Jain, Varsha K, Kosalaraksa, Pope, Woo, Wayne, Yanni, Emad, Zaman, Khalequ, Acosta, Beatriz, Amanullah, Arshad, Ariza, Miguel, Luisa Arroba Basanta, Maria, Bavdekar, Ashish, Carmona, Alfonso, Cousin, Luis, Diaz, Adolfo, Diez-Domingo, Javier, Cagri Dinleyici, Ener, Faust, Saul N, Garcia-Sicilia, Jose, Gomez-Go, Grace D, Antionette Gonzales, Liza, Hacimustafaoglu, Mustafa, Hughes, Stephen M, Izu, Allen, Jackowska, Teresa, Kant, Shashi, Lucero, Marilla, Mares Bermudez, Josep, Martinón-Torres, Federico, Montellano, May, Prymula, Roman, Puthanakit, Thanyawee, Ruzkova, Renata, Sadowska-Krawczenko, Iwona, Soni, Jyoti, Szymanski, Henryk, Ulied, Angels, Schuind, Anne, Innis, Bruce L
Format:	Journal Article
Language:	English
Published:	United States Copyright Wolters Kluwer Health, Inc. All rights reserved 01-08-2019
Subjects:	Child, Preschool Female Hospitalization Humans Infant Influenza Vaccines - administration & dosage Influenza Vaccines - immunology Influenza, Human - diagnosis Influenza, Human - epidemiology Influenza, Human - prevention & control Male Odds Ratio Prevalence Proportional Hazards Models Public Health Surveillance Severity of Illness Index Symptom Assessment Vaccination Vaccines, Inactivated - administration & dosage Vaccines, Inactivated - immunology
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Summary:	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 ratio0.59 (95% confidence intervals0.44−0.77)]. Furthermore, fever >39°C was 46% less frequent following vaccination with IIV4 than with control [crude odds ratio0.54 (95% confidence intervals0.39−0.75)] 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.
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ISSN:	0891-3668 1532-0987
DOI:	10.1097/INF.0000000000002387