Effectiveness of Pandemic H1N1 Vaccine Against Influenza-Related Hospitalization in Children

Author:

Gilca Rodica123,Deceuninck Geneviève2,De Serres Gaston123,Boulianne Nicole12,Sauvageau Chantal123,Quach Caroline4,Boucher François D.56,Skowronski Danuta M.78

Affiliation:

1. Institut National de Santé Publique du Québec, Quebec City, Quebec, Canada;

2. Public Health Research Unit, Quebec University Hospital Centre, Quebec City, Quebec, Canada;

3. Department of Social and Preventive Medicine, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada;

4. Infectious Diseases Division, Department of Pediatrics, The Montreal Children's Hospital, McGill University, Montreal, Quebec, Canada;

5. Department of Paediatrics, Quebec University Hospital Centre, Quebec City, Quebec, Canada;

6. Department of Pediatrics, Faculty of Medicine, Laval University, Quebec City, Quebec, Canada;

7. Epidemiology Services, British Columbia BC Centre for Disease Control, Vancouver, British Columbia, Canada; and

8. School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada

Abstract

OBJECTIVE: Young children are generally considered immunologically naive with respect to influenza exposure opportunities; thus, a 2-dose schedule is recommended when a child is first immunized with conventional influenza vaccine lacking adjuvant. We estimated the effectiveness of a single pediatric dose of AS03-adjuvanted vaccine against hospitalization for confirmed pandemic influenza A/H1N1 (pH1N1) infection in children aged 6 months to 9 years during the fall 2009 vaccination campaign. METHODS: In a matched case-control design, case subjects were children hospitalized for pH1N1 infection in the Fall of 2009, in Quebec, Canada. Controls were nonhospitalized children, matched by age and region of residence. Vaccination status in case subjects and controls was ascertained in relation to the case subject's date of illness onset. Vaccine effectiveness was estimated through conditional logistic regression. RESULTS: The overall effectiveness of a single pediatric dose of vaccine administered ≥14 days before illness onset was 85% (95% confidence interval [CI]: 61% to 94%), varying according to age category but with wide and overlapping CIs: 92% (95% CI: 51% to 99%) in 6–23 month-old children, 89% (95% CI: 34% to 98%) in 2–4 year-olds, and 79% (95% CI: −31% to 96%) in 5–9 year-olds. Overall vaccine effectiveness for immunization ≥10 days before illness onset was slightly lower at 80% (95% CI: 60% to 90%), with similar variation according to age. CONCLUSION: In children aged 6 months to 9 years, a single pediatric dose of the AS03-adjuvanted pH1N1 vaccine was highly protective against hospitalization beginning at 10 and 14 days after vaccination.

Publisher

American Academy of Pediatrics (AAP)

Subject

Pediatrics, Perinatology and Child Health

Reference23 articles.

1. Health Canada. Summary Basis of Decision (SBD) for AREPANRIX H1N1. Available at: www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/sbd-smd/phase1-decision/drug-med/sbd_smd_2010_arepanrix_h1n1_132070-eng.pdf. Accessed April 20, 2011

2. Health Canada. Product information leaflet Arepanrix H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine—Version 4 approved 20 April 2010. Available at: www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/interimorders-arretesurgence/prodinfo_vaccin-eng.php. Accessed April 20, 2011

3. GlaxoSmithKline Inc. A study to evaluate the safety and immunogenicity of A/California/7/2009 (H1N1)v-like vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age. Available at: http://download.gsk-clinicalstudyregister.com/files/3d226ebd-7b95-4336-bb27-12dc16b231b9. Accessed April 20, 2011

4. GlaxoSmithKline Inc. Safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 6 to 35 months. Available at: http://gsk.sylogent.com/files/27868.pdf. Accessed April 20, 2011

5. Sauvageau C, Gilca V. Avis complémentaire concernant la vaccination contre le virus pandémique influenza A (H1N1) 2009 pour les enfants de 6 mois à 9 ans. Québec, Canada: Institut national de santé publique du Québec; 2009. Available at: http://www.inspq.qc.ca/pdf/publications/1025_AvisVaccH1N1Enfants6-9Ans.pdf. Accessed April 20, 2011

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