Publication:
Vaccine for prevention of mild and moderate-to-severe influenza in children

Issued Date

2013-01-01

Resource Type

Article

ISSN

15334406
00284793

DOI

10.1056/NEJMoa1215817

Other identifier(s)

2-s2.0-84890902002

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

New England Journal of Medicine. Vol.369, No.26 (2013), 2481-2491

Suggested Citation

Varsha K. Jain, Luis Rivera, Khalequ Zaman, Roberto A. Espos, Chukiat Sirivichayakul, Beatriz P. Quiambao, Doris M. Rivera-Medina, Pirunghul Kerdpanich, Mehmet Ceyhan, Ener C. Dinleyici, Alejandro Cravioto, Mohammed Yunus, Pornthep Chanthavanich, Kriengsak Limkittikul, Zafer Kurugol, Emre Alhan, Adrian Caplanusi, Serge Durviaux, Philippe Boutet, Opokua Ofori-Anyinam, Vijayalakshmi Chandrasekaran, Ghassan Dbaibo, Bruce L. Innis Vaccine for prevention of mild and moderate-to-severe influenza in children. New England Journal of Medicine. Vol.369, No.26 (2013), 2481-2491. doi:10.1056/NEJMoa1215817 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/32698

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Title

Vaccine for prevention of mild and moderate-to-severe influenza in children

Author(s)

Varsha K. Jain
 Luis Rivera
 Khalequ Zaman
 Roberto A. Espos
 Chukiat Sirivichayakul
 Beatriz P. Quiambao
 Doris M. Rivera-Medina
 Pirunghul Kerdpanich
 Mehmet Ceyhan
 Ener C. Dinleyici
 Alejandro Cravioto
 Mohammed Yunus
 Pornthep Chanthavanich
 Kriengsak Limkittikul
 Zafer Kurugol
 Emre Alhan
 Adrian Caplanusi
 Serge Durviaux
 Philippe Boutet
 Opokua Ofori-Anyinam
 Vijayalakshmi Chandrasekaran
 Ghassan Dbaibo
 Bruce L. Innis

Other Contributor(s)

GlaxoSmithKline, USA
 Hospital Maternidad Nuestra Señora de la Altagracia
 International Centre for Diarrhoeal Disease Research Bangladesh
 De La Salle Health Sciences Institute
 Gokila
 Mahidol University
 Royal Thai Army
 Organización para el Desarrollo y la Investigación Salud en Honduras (ODISH)
 Hacettepe Universitesi
 Eskisehir Osmangazi Universitesi Tip Fakultesi
 Ege University Medical School
 Cukurova Universitesi
 GlaxoSmithKline Pharmaceuticals SA
 American University of Beirut Medical Center

Abstract

BACKGROUND: Commonly used trivalent vaccines contain one influenza B virus lineage and may be ineffective against viruses of the other B lineage. We evaluated the efficacy of a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages. METHODS: In this multinational, phase 3, observer-blinded study, we randomly assigned children 3 to 8 years of age, in a 1:1 ratio, to receive the QIV or a hepatitis A vaccine (control). The primary end point was influenza A or B confirmed by real-time polymerase chain reaction (rt-PCR). Secondary end points were rt-PCR-confirmed, moderate-to-severe influenza and rt-PCR-positive, culture-confirmed influenza. The vaccine efficacy and the effect of vaccination on daily activities and utilization of health care resources were assessed in the total vaccinated cohort (2584 children in each group) and the per-protocol cohort (2379 children in the QIV group and 2398 in the control group). RESULTS: In the total vaccinated cohort, 62 children in the QIV group (2.40%) and 148 in the control group (5.73%) had rt-PCR-confirmed influenza, representing a QIV efficacy of 59.3% (95% confidence interval [CI], 45.2 to 69.7), with efficacy against culturecon-firmed influenza of 59.1% (97.5% CI, 41.2 to 71.5). For moderate-to-severe rt-PCR-confirmed influenza, the attack rate was 0.62% (16 cases) in the QIV group and 2.36% (61 cases) in the control group, representing a QIV efficacy of 74.2% (97.5% CI, 51.5 to 86.2). In the per-protocol cohort, the QIV efficacy was 55.4% (95% CI, 39.1 to 67.3), and the efficacy against culture-confirmed influenza 55.9% (97.5% CI, 35.4 to 69.9); the efficacy among children with moderate-to-severe influenza was 73.1% (97.5% CI, 47.1 to 86.3). The QIV was associated with reduced risks of a body temperature above 39°C and lower respiratory tract illness, as compared with the control vaccine, in the per-protocol cohort (relative risk, 0.29 [95% CI, 0.16 to 0.56] and 0.20 [95% CI, 0.04 to 0.92], respectively). The QIV was immunogenic against all four strains. Serious adverse events occurred in 36 children in the QIV group (1.4%) and in 24 children in the control group (0.9%). CONCLUSIONS: The QIV was efficacious in preventing influenza in children. Copyright © 2013 Massachusetts Medical Society.

Keyword(s)

Medicine

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https://repository.li.mahidol.ac.th/handle/20.500.14594/32698

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