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Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine

BACKGROUND: This study assessed the short and the long term safety of the 2009 AS03 adjuvanted monovalent pandemic vaccine through an active web-based electronic surveillance. We compared its safety profile to that of the seasonal trivalent inactivated influenza vaccine (TIV) for 2010–2011. METHODOL...

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Detalles Bibliográficos
Autores principales: De Serres, Gaston, Gariépy, Marie-Claude, Coleman, Brenda, Rouleau, Isabelle, McNeil, Shelly, Benoît, Mélanie, McGeer, Allison, Ambrose, Ardith, Needham, Judy, Bergeron, Chantal, Grenier, Cynthia, Sleigh, Kenna, Kallos, Arlene, Ouakki, Manale, Ouhoummane, Najwa, Stiver, Grant, Valiquette, Louis, McCarthy, Anne, Bettinger, Julie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389012/
https://www.ncbi.nlm.nih.gov/pubmed/22802929
http://dx.doi.org/10.1371/journal.pone.0038563
Descripción
Sumario:BACKGROUND: This study assessed the short and the long term safety of the 2009 AS03 adjuvanted monovalent pandemic vaccine through an active web-based electronic surveillance. We compared its safety profile to that of the seasonal trivalent inactivated influenza vaccine (TIV) for 2010–2011. METHODOLOGY/PRINCIPAL FINDINGS: Health care workers (HCW) vaccinated in 2009 with the pandemic vaccine (Arepanrix ® from GSK) or HCW vaccinated in 2010 with the 2010–2011 TIV were invited to participate in a web-based active surveillance of vaccine safety. They completed two surveys the day-8 survey covered the first 7 days post-vaccination and the day-29 survey covered events occurring 8 to 28 days after vaccination. Those who reported a problem were called by a nurse to obtain details. The main outcome was the occurrence of a new health problem or the worsening of an existing health condition that resulted in a medical consultation or work absenteeism. For the pandemic vaccine, a six-month follow-up for the occurrence of serious adverse events (SAE) was conducted. Among the 6242 HCW who received the pandemic vaccine, 440 (7%) reported 468 events compared to 328 of the 7645 HCW (4.3%) who reported 339 events after the seasonal vaccine. The 2009 pandemic vaccine was associated with significantly more local reactions than the 2010–2011 seasonal vaccine (1% vs. 0.03%, p<0.001). Paresthesia was reported by 7 HCW (0.1%) after the pandemic vaccine but by none after the seasonal vaccine. For the pandemic vaccine, no clustering of SAE was found in the 6 month follow-up. CONCLUSION: The 2009 pandemic vaccine seems to have a good safety profile, similar to the 2010–2011 TIV, with the exception of local reactions. This surveillance was adequately powered to identify AE associated with an excess risk ≥1 per 1000 vaccinations but is insufficient to detect rare AE. TRIAL REGISTRATION: ClinicalTrials.gov NCT01289418, NCT01318876