PMID- 25483467
OWN - NLM
STAT- MEDLINE
DCOM- 20150914
LR  - 20240326
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 10
IP  - 10
DP  - 2014
TI  - Safety of AS03-adjuvanted inactivated split virion A(H1N1)pdm09 and H5N1 
      influenza virus vaccines administered to adults: pooled analysis of 28 clinical 
      trials.
PG  - 2942-57
LID - 10.4161/21645515.2014.972149 [doi]
AB  - Clinical trials have shown that AS03-adjuvanted H5N1 and A(H1N1)pdm09 vaccines 
      are highly immunogenic, although with an increased reactogenicity profile 
      relative to non-adjuvanted vaccines in terms of the incidence of common injection 
      site and systemic adverse events (AEs). We evaluated pooled safety data from 
      22,521 adults who had received an AS03-adjuvanted H5N1 or A(H1N1)pdm09 influenza 
      or control vaccine with the purpose to identify medically-attended AEs (MAEs), 
      including subsets of serious AEs (SAEs), potentially immune-mediated diseases 
      (pIMDs), and AEs of special interest (AESI), and to explore a potential 
      association of these AEs with the administration of an AS03-adjuvanted influenza 
      vaccine. For participants who had received an AS03-adjuvanted vaccine, the 
      relative risks (RRs) for experiencing a MAE or a SAE compared to control group 
      (participants who had received a non-adjuvanted vaccine or saline placebo) were 
      1.0 (95% confidence interval [CI]: 0.9; 1.1) and 1.1 (95% CI: 0.9; 1.4), 
      respectively. The overall RRs for experiencing an AESI or a pIMD (AS03-adjuvanted 
      vaccine/control) were 1.2 (95% CI: 0.9; 1.6) and 1.7 (95% CI: 0.8; 3.8), 
      respectively. Thirty-8 participants in the AS03-adjuvanted vaccine group had a 
      pIMD reported after vaccine administration, yielding an incidence rate (IR) of 
      351.9 (95% CI: 249.1; 483.1) per 100,000 person-years. The estimated IRs in the 
      AS03-adjuvanted vaccine group were greater than the literature reported rates 
      for: facial paresis/VIIth nerve paralysis, celiac disease, thrombocytopenia and 
      ulcerative colitis. These results do not support an association between 
      AS03-adjuvanted H5N1 and A(H1N1)pdm09 vaccines and the AEs collected in the 
      trials included in the analysis.
FAU - Vaughn, David W
AU  - Vaughn DW
AD  - a GlaxoSmithKline Vaccines ; Rixensart , Belgium.
FAU - Seifert, Harry
AU  - Seifert H
FAU - Hepburn, Anne
AU  - Hepburn A
FAU - Dewe, Walthere
AU  - Dewe W
FAU - Li, Ping
AU  - Li P
FAU - Drame, Mamadou
AU  - Drame M
FAU - Cohet, Catherine
AU  - Cohet C
FAU - Innis, Bruce L
AU  - Innis BL
FAU - Fries, Louis F
AU  - Fries LF
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20141121
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Drug Combinations)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Polysorbates)
RN  - 7QWM220FJH (Squalene)
RN  - A7YT618XBV (AS03 adjuvant)
RN  - H4N855PNZ1 (alpha-Tocopherol)
SB  - IM
MH  - Adjuvants, Immunologic/*adverse effects/therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral/immunology
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Influenza A Virus, H1N1 Subtype/*immunology
MH  - Influenza A Virus, H5N1 Subtype/*immunology
MH  - Influenza Vaccines/adverse effects/*therapeutic use
MH  - Influenza, Human/immunology/prevention & control/virology
MH  - Male
MH  - Middle Aged
MH  - Polysorbates/*adverse effects/therapeutic use
MH  - Risk
MH  - Squalene/*adverse effects/therapeutic use
MH  - Vaccination
MH  - Young Adult
MH  - alpha-Tocopherol/*adverse effects/therapeutic use
PMC - PMC5443104
OTO - NOTNLM
OT  - AE
OT  - Center for Biologics Evaluation and Research; CHMP
OT  - Committee for Medicinal Products for Human Use; MedDRA
OT  - Good Clinical Practice; CBER
OT  - Medical Dictionary for Regulatory Activities; PT
OT  - adverse event of special interest; MAE
OT  - adverse event; pIMD
OT  - confidence interval; RR
OT  - incidence rate; GCP
OT  - medically-attended adverse event; SAE
OT  - new onset chronic disease; CI
OT  - potential immune-mediated disease; AESI
OT  - preferred term
OT  - relative risk; SD
OT  - safety, potential immune-mediated disease, A(H1N1)pdm09 vaccine, H5N1 vaccine, 
      influenza A(H5N1), pandemic influenza A(H1N1), pooled analysis
OT  - serious adverse event; NOCD
OT  - standard deviation; IR
EDAT- 2014/12/09 06:00
MHDA- 2015/09/15 06:00
PMCR- 2014/11/21
CRDT- 2014/12/09 06:00
PHST- 2014/12/09 06:00 [entrez]
PHST- 2014/12/09 06:00 [pubmed]
PHST- 2015/09/15 06:00 [medline]
PHST- 2014/11/21 00:00 [pmc-release]
AID - 972149 [pii]
AID - 10.4161/21645515.2014.972149 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2014;10(10):2942-57. doi: 10.4161/21645515.2014.972149. 
      Epub 2014 Nov 21.