Effectiveness of pandemic and seasonal influenza vaccines in preventing laboratory-confirmed influenza in adults: a clinical cohort study during epidemic seasons 2009-2010 and 2010-2011 in Finland

Ritva K Syrjänen, Jukka Jokinen, Thedi Ziegler, Jonas Sundman, Mika Lahdenkari, Ilkka Julkunen, Terhi M Kilpi, Ritva K Syrjänen, Jukka Jokinen, Thedi Ziegler, Jonas Sundman, Mika Lahdenkari, Ilkka Julkunen, Terhi M Kilpi

Abstract

Background: One dose of pandemic influenza vaccine Pandemrix (GlaxoSmithKline) was offered to the entire population of Finland in 2009-10. We conducted a prospective clinical cohort study to determine the vaccine effectiveness in preventing febrile laboratory-confirmed influenza infection during the influenza season 2009-10 and continued the study in 2010-11.

Methods: In total, 3,518 community dwelling adults aged 18-75 years living in Tampere city were enrolled. The participants were not assigned to any vaccination regimen, but they could participate in the study regardless of their vaccination status or intention to be vaccinated with the pandemic or seasonal influenza vaccine. They were asked to report if they received Pandemrix in 2009-10 and/or trivalent influenza vaccine in 2010-11. Vaccinations were verified from medical records. The participants were instructed to report all acute symptoms of respiratory tract infection with fever (at least 38°C) and pneumonias to the study staff. Nasal and oral swabs were obtained within 5-7 days after symptom onset and influenza-specific RNA was identified by reverse transcription polymerase chain reaction.

Results: In 2009-10, the estimated vaccine effectiveness was 81% (95%CI 30-97). However, the vaccine effectiveness could not be estimated reliably, because only persons in prioritized groups were vaccinated before/during the first pandemic wave and many participants were enrolled when they already had the symptoms of A(H1N1)pdm09 influenza infection. In 2010-11, 2,276 participants continued the follow-up. The vaccine effectiveness, adjusted for potential confounding factors was 81% (95%CI 41-96) for Pandemrix only and 88% (95%CI 63-97) for either Pandemrix or trivalent influenza vaccine 2010-11 or both, respectively.

Conclusion: Vaccination with an AS03-adjuvanted pandemic vaccine in 2009-10 was still effective in preventing A(H1N1)pdm09 influenza during the following epidemic season in 2010-11.

Trial registration: ClinicalTrials.gov NCT01024725. NCT01206114.

Conflict of interest statement

Competing Interests: THL has received research support from GlaxoSmithKline Biologicals and Pfizer for a pneumococcal vaccine trial and other pneumococcal studies, not related to this study. T. Kilpi has acted as a principal investigator and R. Syrjänen, J. Jokinen and J. Sundman have acted as co-investigators in these studies but not received any personal payments. J. Jokinen is a member of Independent Data Monitoring Committee for Dengue vaccine trial of Sanofi Pasteur. None of the authors have any financial interest in the vaccines or manufacturers discussed in this article apart from those disclosed. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Figure 1. Schematic representation of timing of…
Figure 1. Schematic representation of timing of epidemics, study follow-up and vaccinations.
Time course of influenza epidemics in Finland according to the National Infectious Disease Registry (NIDR) and the follow-up of study participants during the epidemic seasons 2009–10 (panel A) and 2010–11 (panel B). Note differences in scales. The main circulating influenza A virus during both epidemic seasons was A(H1N1)pdm09; in 2009–10 only sporadic H3N2 and few influenza B virus findings were observed and during 2010–11>95% of the influenza A strains were A(H1N1)pdm09. The figure shows the vaccination times of the study participants with Pandemrix and seasonal trivalent influenza vaccine (TIV) in 2010–11. The national prioritization order for pandemic vaccination (here shown for adults) in 2009–10 was determined on medical grounds.
Figure 2. Flow chart of data selection.
Figure 2. Flow chart of data selection.
The figure illustrates the exclusion and inclusion of participants for the analysis of the effectiveness of pandemic and seasonal influenza vaccines in preventing laboratory-confirmed influenza in Finnish adults: a clinical cohort study. A, the study during the epidemic season 2009–10. Invitation letters were sent home and distributed to pregnant women at maternity clinics and to healthcare professionals at their work place. In addition, announcements were published in newspapers. Of the 3,464 participants followed and vaccination status known during 2009–10, 2,731 were enrolled after the first epidemic peak in 2009. Of the 32 subjects without contacts 2009–2010, 22 had failed to receive text messages or phone calls. They were contacted after the follow-up and invited to the follow-up 2010–11. B, the study during the epidemic season 2010–11.

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