PMID- 21534891
OWN - NLM
STAT- MEDLINE
DCOM- 20111207
LR  - 20131121
IS  - 1651-1980 (Electronic)
IS  - 0036-5548 (Linking)
VI  - 43
IP  - 9
DP  - 2011 Sep
TI  - Explorations of clinical trials and pharmacovigilance databases of 
      MF59(R)-adjuvanted influenza vaccines for associated cases of narcolepsy.
PG  - 702-6
LID - 10.3109/00365548.2011.580777 [doi]
AB  - BACKGROUND: A potential association between the new onset of narcolepsy 
      accompanied by cataplexy - a putative autoimmune disorder, and vaccination with 
      an AS03-adjuvanted A(H1N1) pandemic influenza vaccine is under investigation. We 
      sought cases of narcolepsy from the pharmacovigilance database of a pandemic 
      vaccine adjuvanted with another emulsion adjuvant, MF59((R)), and a pooled clinical 
      trials database of MF59-adjuvanted and non-adjuvanted influenza vaccine 
      recipients. METHODS: Using 6 narrowly restrictive and 24 broad sleep 
      disturbance-related MedDRA preferred search terms (PT), we analysed spontaneous 
      adverse events (AEs) reports received through July 31, 2010 and adjudicated 
      suspected cases with onset 1 week-3 months after vaccination, against 
      standardized clinical criteria defining narcolepsy. A pooled clinical trials 
      database of 115 trials comprising 79,004 subjects receiving various 
      MF59-adjuvanted and non-adjuvanted influenza vaccines in controlled and 
      uncontrolled trials was analysed for cases with a narrow PT that had onset 1 week 
      after vaccination. RESULTS: Five thousand three hundred and five spontaneous AE 
      reports were received from an estimated 23.26 million MF59-adjuvanted pandemic 
      vaccine doses that had been administered. No case meeting the clinical definition 
      of narcolepsy was discovered. In the pooled database of controlled clinical 
      trials, no cases were discovered using the narrow PT, and rates and adjusted odds 
      ratio for broad search terms for all temporal windows showed no significant 
      difference between subjects receiving MF59-adjuvanted or non-adjuvanted vaccine. 
      CONCLUSIONS: No case of narcolepsy and no evidence of an increased risk of 
      sleep-related AEs were discovered in recipients of MF59-adjuvanted A(H1N1) 
      pandemic and other MF59-adjuvanted influenza vaccine.
FAU - Tsai, Theodore F
AU  - Tsai TF
AD  - Novartis Vaccines and Diagnostics Inc., 350 Massachusetts Avenue, Cambridge, MA 
      02139, USA. theodore.tsai@novartis.com
FAU - Crucitti, Antonio
AU  - Crucitti A
FAU - Nacci, Pantaleo
AU  - Nacci P
FAU - Nicolay, Uwe
AU  - Nicolay U
FAU - Della Cioppa, Giovanni
AU  - Della Cioppa G
FAU - Ferguson, John
AU  - Ferguson J
FAU - Clemens, Ralf
AU  - Clemens R
LA  - eng
PT  - Journal Article
DEP - 20110502
PL  - England
TA  - Scand J Infect Dis
JT  - Scandinavian journal of infectious diseases
JID - 0215333
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 7QWM220FJH (Squalene)
SB  - IM
CIN - Scand J Infect Dis. 2011 Dec;43(11-12):993. PMID: 21851329
MH  - Adjuvants, Immunologic/administration & dosage/*adverse effects
MH  - Humans
MH  - Influenza Vaccines/administration & dosage/*adverse effects
MH  - Narcolepsy/*chemically induced/*epidemiology/etiology
MH  - Polysorbates/administration & dosage
MH  - Squalene/administration & dosage
EDAT- 2011/05/04 06:00
MHDA- 2011/12/13 00:00
CRDT- 2011/05/04 06:00
PHST- 2011/05/04 06:00 [entrez]
PHST- 2011/05/04 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - 10.3109/00365548.2011.580777 [doi]
PST - ppublish
SO  - Scand J Infect Dis. 2011 Sep;43(9):702-6. doi: 10.3109/00365548.2011.580777. Epub 
      2011 May 2.