PMID- 30904674
OWN - NLM
STAT- MEDLINE
DCOM- 20191024
LR  - 20191024
IS  - 1878-3511 (Electronic)
IS  - 1201-9712 (Linking)
VI  - 85S
DP  - 2019 Aug
TI  - Cumulative clinical experience with MF59-adjuvanted trivalent seasonal influenza 
      vaccine in young children and adults 65 years of age and older.
PG  - S10-S17
LID - S1201-9712(19)30149-3 [pii]
LID - 10.1016/j.ijid.2019.03.020 [doi]
AB  - OBJECTIVE: To assess the long-term safety of MF59-adjuvanted trivalent influenza 
      vaccine (aIIV3; Fluad) in adults >/=65 years of age. METHODS: Data from 36 primary 
      vaccination and 7 re-vaccination Phase I through III trials were analyzed; 7532 
      subjects received aIIV3 and 5198 subjects a nonadjuvanted trivalent inactivated 
      influenza vaccine (IIV3). These trials were evaluated in 2 data poolings: 
      first-dose randomized controlled trials (FD-RCT) and revaccination trials. 
      Spontaneously reported adverse events (AEs) from post-marketing surveillance were 
      also analyzed. RESULTS: The percentages of subjects reporting AEs following 
      vaccination were similar between aIIV3 and IIV3: 24.8% for aIIV3 vs 26.7% for 
      IIV3 (relative risk [RR] 0.94; 95% confidence interval [CI] 0.87-1.01). The 
      percentage of subjects with serious AEs was 6.7% for aIIV3 vs 7.0% for IIV3 (RR 
      0.95; 95% CI 0.82-1.09). Percentages of subjects with AEs leading to withdrawal, 
      hospitalizations, adverse events of special interest (AESIs), and deaths between 
      vaccination groups were similar. There was no signal of disproportionality for 
      AESIs associated with aIIV3 compared to IIV3 in the post-marketing database. 
      CONCLUSIONS: This integrated safety analysis demonstrates an acceptable safety 
      profile for aIIV3 in adults >/=65 years of age.
CI  - Copyright (c) 2019. Published by Elsevier Ltd.
FAU - Lindert, Kelly
AU  - Lindert K
AD  - Novartis Vaccines & Diagnostics, Cambridge, MA, USA.
FAU - Leav, Brett
AU  - Leav B
AD  - Seqirus Inc., Cambridge, MA, USA. Electronic address: brett.leav@seqirus.com.
FAU - Heijnen, Esther
AU  - Heijnen E
AD  - Seqirus Inc., Amsterdam, The Netherlands.
FAU - Barrett, Julia
AU  - Barrett J
AD  - Biologics Consulting, Alexandria, VA, USA.
FAU - Nicolay, Uwe
AU  - Nicolay U
AD  - Novartis Vaccines & Diagnostics, GmbH Marburg, Germany.
LA  - eng
PT  - Journal Article
DEP - 20190320
PL  - Canada
TA  - Int J Infect Dis
JT  - International journal of infectious diseases : IJID : official publication of the 
      International Society for Infectious Diseases
JID - 9610933
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 0 (Vaccines, Inactivated)
RN  - 7QWM220FJH (Squalene)
SB  - IM
MH  - Adjuvants, Immunologic/*adverse effects
MH  - Aged
MH  - Child, Preschool
MH  - Clinical Trials as Topic
MH  - Female
MH  - Hospitalization
MH  - Humans
MH  - Immunization, Secondary
MH  - Influenza Vaccines/*adverse effects
MH  - Influenza, Human/prevention & control
MH  - Male
MH  - Mortality
MH  - Polysorbates/*adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Seasons
MH  - Squalene/*adverse effects
MH  - Vaccines, Inactivated/adverse effects
OTO - NOTNLM
OT  - Adjuvant
OT  - Elderly
OT  - Influenza
OT  - MF59
OT  - Safety
OT  - Vaccine
EDAT- 2019/03/25 06:00
MHDA- 2019/10/28 06:00
CRDT- 2019/03/25 06:00
PHST- 2019/02/16 00:00 [received]
PHST- 2019/03/12 00:00 [revised]
PHST- 2019/03/14 00:00 [accepted]
PHST- 2019/03/25 06:00 [pubmed]
PHST- 2019/10/28 06:00 [medline]
PHST- 2019/03/25 06:00 [entrez]
AID - S1201-9712(19)30149-3 [pii]
AID - 10.1016/j.ijid.2019.03.020 [doi]
PST - ppublish
SO  - Int J Infect Dis. 2019 Aug;85S:S10-S17. doi: 10.1016/j.ijid.2019.03.020. Epub 
      2019 Mar 20.