title: Using surveillance data to estimate pandemic vaccine effectiveness against laboratory confirmed influenza A(H1N1)2009 infection: two case-control studies, Spain, season 2009-2010.
abstract: BACKGROUND
  Physicians of the Spanish Influenza Sentinel Surveillance System report and systematically swab patients attended to their practices for influenza-like illness (ILI). Within the surveillance system, some Spanish regions also participated in an observational study aiming at estimating influenza vaccine effectiveness (cycEVA study). During the season 2009-2010, we estimated pandemic influenza vaccine effectiveness using both the influenza surveillance data and the cycEVA study.
  
  
  METHODS
  We conducted two case-control studies using the test-negative design, between weeks 48/2009 and 8/2010 of the pandemic season. The surveillance-based study included all swabbed patients in the sentinel surveillance system. The cycEVA study included swabbed patients from seven Spanish regions. Cases were laboratory-confirmed pandemic influenza A(H1N1)2009. Controls were ILI patients testing negative for any type of influenza. Variables collected in both studies included demographic data, vaccination status, laboratory results, chronic conditions, and pregnancy. Additionally, cycEVA questionnaire collected data on previous influenza vaccination, smoking, functional status, hospitalisations, visits to the general practitioners, and obesity. We used logistic regression to calculate adjusted odds ratios (OR), computing pandemic influenza vaccine effectiveness as (1-OR)*100.
  
  
  RESULTS
  We included 331 cases and 995 controls in the surveillance-based study and 85 cases and 351 controls in the cycEVA study. We detected nine (2.7%) and two (2.4%) vaccine failures in the surveillance-based and cycEVA studies, respectively. Adjusting for variables collected in surveillance database and swabbing month, pandemic influenza vaccine effectiveness was 62% (95% confidence interval (CI): -5; 87). The cycEVA vaccine effectiveness was 64% (95%CI: -225; 96) when adjusting for common variables with the surveillance system and 75% (95%CI: -293; 98) adjusting for all variables collected.
  
  
  CONCLUSIONS
  Point estimates of the pandemic influenza vaccine effectiveness suggested a protective effect of the pandemic vaccine against laboratory-confirmed influenza A(H1N1)2009 in the season 2009-2010. Both studies were limited by the low vaccine coverage and the late start of the vaccination campaign. Routine influenza surveillance provides reliable estimates and could be used for influenza vaccine effectiveness studies in future seasons taken into account the surveillance system limitations.
authors: Institute of Health Carlos III, National Centre of Epidemiology, c/Monforte de Lemos no,5, 28029 Madrid, Spain. csavulescu@isciii.es
authors: Camelia
authors: C
authors: Savulescu
authors: Silvia
authors: S
authors: Jiménez-Jorge
authors: Salvador
authors: S
authors: de Mateo
authors: Francisco
authors: F
authors: Pozo
authors: Inmaculada
authors: I
authors: Casas
authors: Pilar Pérez
authors: PP
authors: Breña
authors: Antonia
authors: A
authors: Galmés
authors: Juana M
authors: JM
authors: Vanrell
authors: Carolina
authors: C
authors: Rodriguez
authors: Tomas
authors: T
authors: Vega
authors: Ana
authors: A
authors: Martinez
authors: Nuria
authors: N
authors: Torner
authors: Julián M
authors: JM
authors: Ramos
authors: Maria C
authors: MC
authors: Serrano
authors: Jesús
authors: J
authors: Castilla
authors: Manuel García
authors: MG
authors: Cenoz
authors: Jone M
authors: JM
authors: Altzibar
authors: Jose M
authors: JM
authors: Arteagoitia
authors: Carmen
authors: C
authors: Quiñones
authors: Milagros
authors: M
authors: Perucha
authors: Amparo
authors: A
authors: Larrauri
mesh_terms: D000293:Adolescent; D000328:Adult; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology / Q000302:isolation & purification*; D007252:Influenza Vaccines / Q000627:therapeutic use*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011159:Population Surveillance; D013030:Spain / Q000453:epidemiology; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines