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PLoS ONE. Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine
[Source: PLoS ONE, full text: (LINK). Abstract, edited.]
Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine
Gaston De Serres<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP><SUP>*</SUP>, Marie-Claude Gari?py<SUP>1</SUP>, Brenda Coleman<SUP>3</SUP>, Isabelle Rouleau<SUP>1</SUP>, Shelly McNeil<SUP>4</SUP>, M?lanie Beno?t<SUP>1</SUP>, Allison McGeer<SUP>3</SUP>, Ardith Ambrose<SUP>4</SUP>, Judy Needham<SUP>5</SUP>, Chantal Bergeron<SUP>6</SUP>, Cynthia Grenier<SUP>7</SUP>, Kenna Sleigh<SUP>8</SUP>, Arlene Kallos<SUP>5</SUP>, Manale Ouakki<SUP>2</SUP>, Najwa Ouhoummane<SUP>2</SUP>, Grant Stiver<SUP>8</SUP>, Louis Valiquette<SUP>7</SUP>, Anne McCarthy<SUP>6</SUP>, Julie Bettinger<SUP>5</SUP>, on behalf of the PHAC-CIHR influenza Research Network (PCIRN)
1 Centre de recherche du CHUQ-CHUL, Laval University, Quebec City, Quebec, Canada, 2 Institut national de sant? publique du Qu?bec (INSPQ), Quebec City, Quebec, Canada, 3 Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada, 4 Canadian Center for Vaccinology, Halifax, Nova Scotia, Canada, 5 Vaccine Evaluation Center, BC Children?s Hospital and the University of British Columbia, Vancouver, British Columbia, Canada, 6 The Ottawa General Hospital, Ottawa, Ontario, Canada, 7 Universit? de Sherbrooke, Sherbrooke, Quebec, Canada, 8 University of British Columbia, Vancouver, British Columbia, Canada
Abstract
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
Citation: De Serres G, Gari?py M-C, Coleman B, Rouleau I, McNeil S, et al. (2012) Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine. PLoS ONE 7(7): e38563. doi:10.1371/journal.pone.0038563
Editor: Benjamin J. Cowling, University of Hong Kong, Hong Kong
Received: February 2, 2012; Accepted: May 9, 2012; Published: July 3, 2012
Copyright: ? 2012 De Serres et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was funded by the Public Health Agency of Canada (PHAC)/Canada Institutes for Health Research (CIHR) Influenza Research network (PCIRN) and by GlaxoSmithKline (GSK) Canada. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have read the journal?s policy and have the following conflicts: Gaston De Serres has received research grant from GSK, Sanofi Pasteur. Shelly McNeil has research grants from GSK, Pfizer, and Sanofi and participated in clinical trials for GSK, Sanofi, Pfizer, Merck, Novartis. She has received speaking fees/honoraria from Merck, GsK and Pfizer. M?lanie Beno?t owned Janssen-ortho stocks and/or stock options and was an employee of Janssen-ortho (Johnson and Johnson) until 2009. Louis Valiquette has served on advisory boards for Abbott and Wyeth, and has received compensation to conduct clinical trials involving antibacterials from Genzyme, Wyeth, Merck, Pfizer, BioCryst, and Optimer. The other authors have declared that no competing interests exist. This does not alter the authors? adherence to all the PLoS ONE policies on sharing data and materials.
* E-mail: gaston.deserres@ssss.gouv.qc.ca
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Gaston De Serres<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP><SUP>*</SUP>, Marie-Claude Gari?py<SUP>1</SUP>, Brenda Coleman<SUP>3</SUP>, Isabelle Rouleau<SUP>1</SUP>, Shelly McNeil<SUP>4</SUP>, M?lanie Beno?t<SUP>1</SUP>, Allison McGeer<SUP>3</SUP>, Ardith Ambrose<SUP>4</SUP>, Judy Needham<SUP>5</SUP>, Chantal Bergeron<SUP>6</SUP>, Cynthia Grenier<SUP>7</SUP>, Kenna Sleigh<SUP>8</SUP>, Arlene Kallos<SUP>5</SUP>, Manale Ouakki<SUP>2</SUP>, Najwa Ouhoummane<SUP>2</SUP>, Grant Stiver<SUP>8</SUP>, Louis Valiquette<SUP>7</SUP>, Anne McCarthy<SUP>6</SUP>, Julie Bettinger<SUP>5</SUP>, on behalf of the PHAC-CIHR influenza Research Network (PCIRN)
1 Centre de recherche du CHUQ-CHUL, Laval University, Quebec City, Quebec, Canada, 2 Institut national de sant? publique du Qu?bec (INSPQ), Quebec City, Quebec, Canada, 3 Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada, 4 Canadian Center for Vaccinology, Halifax, Nova Scotia, Canada, 5 Vaccine Evaluation Center, BC Children?s Hospital and the University of British Columbia, Vancouver, British Columbia, Canada, 6 The Ottawa General Hospital, Ottawa, Ontario, Canada, 7 Universit? de Sherbrooke, Sherbrooke, Quebec, Canada, 8 University of British Columbia, Vancouver, British Columbia, Canada
Abstract
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
Citation: De Serres G, Gari?py M-C, Coleman B, Rouleau I, McNeil S, et al. (2012) Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine. PLoS ONE 7(7): e38563. doi:10.1371/journal.pone.0038563
Editor: Benjamin J. Cowling, University of Hong Kong, Hong Kong
Received: February 2, 2012; Accepted: May 9, 2012; Published: July 3, 2012
Copyright: ? 2012 De Serres et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was funded by the Public Health Agency of Canada (PHAC)/Canada Institutes for Health Research (CIHR) Influenza Research network (PCIRN) and by GlaxoSmithKline (GSK) Canada. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have read the journal?s policy and have the following conflicts: Gaston De Serres has received research grant from GSK, Sanofi Pasteur. Shelly McNeil has research grants from GSK, Pfizer, and Sanofi and participated in clinical trials for GSK, Sanofi, Pfizer, Merck, Novartis. She has received speaking fees/honoraria from Merck, GsK and Pfizer. M?lanie Beno?t owned Janssen-ortho stocks and/or stock options and was an employee of Janssen-ortho (Johnson and Johnson) until 2009. Louis Valiquette has served on advisory boards for Abbott and Wyeth, and has received compensation to conduct clinical trials involving antibacterials from Genzyme, Wyeth, Merck, Pfizer, BioCryst, and Optimer. The other authors have declared that no competing interests exist. This does not alter the authors? adherence to all the PLoS ONE policies on sharing data and materials.
* E-mail: gaston.deserres@ssss.gouv.qc.ca