PMID- 26809939 OWN - NLM STAT- MEDLINE DCOM- 20171026 LR - 20181113 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 12 IP - 4 DP - 2016 Apr 2 TI - Tolerability of 2 doses of pandemic influenza vaccine (Focetria(R)) and of a prior dose of seasonal 2009-2010 influenza vaccination in the Netherlands. PG - 1027-32 LID - 10.1080/21645515.2015.1120394 [doi] AB - In the Netherlands, people indicated for seasonal influenza vaccination are divided in 3 risk groups, i.e. those less than 60 y (y) with comorbidity and those 60 y and over with and without comorbidity. Those risk groups were also eligible for pandemic vaccination during the 2009 influenza A(H1N1) pandemic. We assessed tolerability of seasonal influenza vaccination and 2 doses of pandemic influenza A(H1N1) vaccine, adjuvanted with MF-59, administered 2 and 5 weeks after seasonal 2009-2010 vaccination among adults. Vaccinees were asked to return questionnaires on local and systemic adverse events (AEs) after each of 3 consecutive vaccinations given at the office of their General Practitioner. Sex- and risk group-specific AE-frequencies were calculated. Generalized Linear Mixed Model with seasonal vaccination as reference was used to calculate odds ratios (ORs) for AEs of the 2 pandemic doses. 5553 questionnaires (3251 vaccinees) were returned. Vaccinees reported any local AE after seasonal vaccination and both pandemic doses in 34%, 23%, and 18%, respectively. These percentages were 29%, 25%, and 16% for any systemic AE. Men reported fewer local and systemic AEs then women (p<0.0001). The risk of local (OR range 0.34-0.63) and systemic (OR range 0.39-0.99) AEs (overall, stratified by risk group and by sex) was lower after both pandemic doses compared to seasonal vaccination. This decreased risk was more pronounced after the second pandemic dose than after the first. Therefore, we conclude that MF59-adjuvanted pandemic vaccine given after seasonal vaccination was well tolerated. FAU - van der Maas, N A T AU - van der Maas NA AD - a Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) , Bilthoven , the Netherlands. FAU - Godefrooij, S AU - Godefrooij S AD - a Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) , Bilthoven , the Netherlands. AD - b Department of Health Science, VU University Amsterdam , Amsterdam , the Netherlands. FAU - Vermeer-de Bondt, P E AU - Vermeer-de Bondt PE AD - a Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) , Bilthoven , the Netherlands. FAU - de Melker, H E AU - de Melker HE AD - a Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) , Bilthoven , the Netherlands. FAU - Kemmeren, J AU - Kemmeren J AD - a Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM) , Bilthoven , the Netherlands. LA - eng PT - Journal Article DEP - 20160125 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (Adjuvants, Immunologic) RN - 0 (Antibodies, Viral) RN - 0 (Influenza Vaccines) RN - 0 (focetria) SB - IM MH - Adjuvants, Immunologic MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Viral/blood MH - Female MH - Hemagglutination Inhibition Tests MH - Humans MH - Immunization Schedule MH - Influenza A Virus, H1N1 Subtype/immunology MH - Influenza Vaccines/administration & dosage/*adverse effects MH - Influenza, Human/epidemiology/*prevention & control/virology MH - Linear Models MH - Male MH - Middle Aged MH - Netherlands/epidemiology MH - Pandemics/*prevention & control MH - Seasons MH - Surveys and Questionnaires MH - Vaccination MH - Young Adult PMC - PMC4962940 OTO - NOTNLM OT - adverse event following immunization OT - influenza OT - pandemic OT - seasonal OT - tolerability OT - vaccination EDAT- 2016/01/27 06:00 MHDA- 2017/10/27 06:00 PMCR- 2017/01/25 CRDT- 2016/01/27 06:00 PHST- 2016/01/27 06:00 [entrez] PHST- 2016/01/27 06:00 [pubmed] PHST- 2017/10/27 06:00 [medline] PHST- 2017/01/25 00:00 [pmc-release] AID - 1120394 [pii] AID - 10.1080/21645515.2015.1120394 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2016 Apr 2;12(4):1027-32. doi: 10.1080/21645515.2015.1120394. Epub 2016 Jan 25.