PMID- 22902681
OWN - NLM
STAT- MEDLINE
DCOM- 20130211
LR  - 20131121
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 30
IP  - 45
DP  - 2012 Oct 5
TI  - A prospective observational safety study on MF59((R)) adjuvanted cell 
      culture-derived vaccine, Celtura((R)) during the A/H1N1 (2009) influenza pandemic.
PG  - 6436-43
LID - S0264-410X(12)01171-1 [pii]
LID - 10.1016/j.vaccine.2012.08.005 [doi]
AB  - BACKGROUND: The present study was a prospective observational study to evaluate 
      the safety profile of Celtura((R)), a monovalent, cell culture-derived, inactivated 
      subunit influenza vaccine prepared from A/California/07/2009(H1N1) with the 
      adjuvant MF59((R)). Subjects were enrolled prospectively during the H1N1 2009 
      influenza pandemic at medical centres in Colombia, Chile, Switzerland, and 
      Germany during the period December 2009 to June 2010. METHODS: Subjects ages 18 
      and older were followed for the occurrence of adverse events (AEs) for six months 
      after vaccination. Adverse events of special interest (AESIs) were neuritis, 
      convulsion (seizure), anaphylaxis, encephalitis, vasculitis, Guillain-Barre 
      syndrome, demyelinating conditions, Bell's palsy, and laboratory-confirmed 
      vaccination failure. RESULTS: Overall, 7348 AEs were reported in 2296 of 3989 
      enrolled subjects (57.6%). Only two AEs were considered related to injection site 
      reactions. No laboratory-confirmed cases of influenza were reported. There were 
      108 medically confirmed serious adverse events (SAEs) reported among 73 subjects 
      with 6 such SAEs described as possibly or probably related to vaccination. Three 
      fatal cases were reported and assessed as not related to vaccination. Two AESIs 
      classified as convulsion were reported and assessed as not related to 
      vaccination. Both AESIs occurred well outside the pre-specified 7 day risk window 
      representing the likely timeframe of the occurrence of seizure following 
      vaccination. CONCLUSIONS: The results of this study support the overall good 
      safety profile of MF59 adjuvanted cell culture-derived influenza vaccine as 
      administered in adults during the 2009-2010 H1N1 influenza pandemic. No concern 
      is raised regarding the occurrence of AESIs.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Reynales, Humberto
AU  - Reynales H
AD  - Centro de Atencion e Investigacion Medica (CAIMED), Bogota, Colombia. 
      humberto.reynales@caimed.com
FAU - Astudillo, Pedro
AU  - Astudillo P
FAU - de Valliere, Serge
AU  - de Valliere S
FAU - Hatz, Christoph
AU  - Hatz C
FAU - Schlagenhauf, Patricia
AU  - Schlagenhauf P
FAU - Rath, Barbara
AU  - Rath B
FAU - Velentgas, Priscilla
AU  - Velentgas P
FAU - Farina, Ariel
AU  - Farina A
FAU - Sales-Carmona, Victor
AU  - Sales-Carmona V
FAU - Groth, Nicola
AU  - Groth N
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120815
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 7QWM220FJH (Squalene)
SB  - IM
MH  - Adjuvants, Immunologic/adverse effects/pharmacology
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Humans
MH  - Influenza A Virus, H1N1 Subtype
MH  - Influenza Vaccines/administration & dosage/*adverse effects/biosynthesis
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Polysorbates/adverse effects/pharmacology
MH  - *Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Squalene/adverse effects/pharmacology
MH  - Young Adult
EDAT- 2012/08/21 06:00
MHDA- 2013/02/12 06:00
CRDT- 2012/08/21 06:00
PHST- 2012/05/23 00:00 [received]
PHST- 2012/07/27 00:00 [revised]
PHST- 2012/08/02 00:00 [accepted]
PHST- 2012/08/21 06:00 [entrez]
PHST- 2012/08/21 06:00 [pubmed]
PHST- 2013/02/12 06:00 [medline]
AID - S0264-410X(12)01171-1 [pii]
AID - 10.1016/j.vaccine.2012.08.005 [doi]
PST - ppublish
SO  - Vaccine. 2012 Oct 5;30(45):6436-43. doi: 10.1016/j.vaccine.2012.08.005. Epub 2012 
      Aug 15.