PMID- 31051279
OWN - NLM
STAT- MEDLINE
DCOM- 20191024
LR  - 20191024
IS  - 1878-3511 (Electronic)
IS  - 1201-9712 (Linking)
VI  - 85S
DP  - 2019 Aug
TI  - MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and 
      immunogenicity in young children at risk of influenza complications.
PG  - S18-S25
LID - S1201-9712(19)30194-8 [pii]
LID - 10.1016/j.ijid.2019.04.023 [doi]
AB  - OBJECTIVE: To assess the safety and immunogenicity of the MF59-adjuvanted 
      seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad) in children aged 
      6 months through 5 years who are at risk of influenza complications. METHODS: A 
      retrospective analysis was performed to examine unsolicited adverse events (AEs) 
      in an integrated dataset from six randomized clinical studies that compared aIIV3 
      with non-adjuvanted inactivated influenza vaccines (IIV3). The integrated safety 
      set comprised 10 784 children, of whom 373 (3%) were at risk of influenza 
      complications. RESULTS: The at-risk safety population comprised 373 children aged 
      6 months through 5 years: 179 received aIIV3 and 194 received non-adjuvanted IIV3 
      (128 subjects received a licensed IIV3). The most important risk factors were 
      respiratory system illnesses (62-70%) and infectious and parasitic diseases 
      (33-39%). During the treatment period, unsolicited AEs occurred in 54% of at-risk 
      children and 55% of healthy children who received aIIV3; of those receiving 
      licensed IIV3, 59% of at-risk and 62% of healthy subjects reported an unsolicited 
      AE. The most common AEs were infections, including upper respiratory tract 
      infection. Serious AEs (SAEs) were reported in <10% of at-risk subjects, and no 
      vaccine-related SAEs were observed. In the immunogenicity subset (involving 103 
      participants from one study), geometric mean titers (GMTs) were approximately 2- 
      to 3-fold higher with aIIV3 than with IIV3 for all three homologous strains 
      (A/H1N1, A/H3N2, and B). Seroconversion rates were high for both aIIV3 (79-96%) 
      and IIV3 (83-89%). CONCLUSIONS: In young children at risk of influenza 
      complications, aIIV3 was well-tolerated and had a safety profile that was 
      generally similar to that of non-adjuvanted IIV3. Similar to the not-at-risk 
      population, the immune response in at-risk subjects receiving aIIV3 was increased 
      over those receiving IIV3, suggesting aIIV3 is a valuable option in young 
      children at risk of influenza complications.
CI  - Copyright (c) 2019. Published by Elsevier Ltd.
FAU - Patel, Sanjay S
AU  - Patel SS
AD  - Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.
FAU - Bizjajeva, Svetlana
AU  - Bizjajeva S
AD  - Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.
FAU - Heijnen, Esther
AU  - Heijnen E
AD  - Seqirus Netherlands BV, Amsterdam, The Netherlands.
FAU - Oberye, Janine
AU  - Oberye J
AD  - Seqirus Netherlands BV, Amsterdam, The Netherlands. Electronic address: 
      janine.oberye@seqirus.com.
LA  - eng
PT  - Journal Article
DEP - 20190430
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  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Infant
MH  - Influenza A Virus, H1N1 Subtype/immunology
MH  - Influenza A Virus, H3N2 Subtype/immunology
MH  - Influenza Vaccines/*adverse effects/*immunology
MH  - Influenza, Human/complications/prevention & control
MH  - Male
MH  - *Polysorbates/adverse effects
MH  - Retrospective Studies
MH  - Seasons
MH  - Seroconversion
MH  - *Squalene/adverse effects
MH  - Vaccines, Inactivated/immunology
OTO - NOTNLM
OT  - Adjuvant
OT  - Children
OT  - Influenza
OT  - MF59
OT  - Risk of influenza complications
OT  - Vaccine
EDAT- 2019/05/06 06:00
MHDA- 2019/10/28 06:00
CRDT- 2019/05/04 06:00
PHST- 2019/02/16 00:00 [received]
PHST- 2019/04/22 00:00 [revised]
PHST- 2019/04/24 00:00 [accepted]
PHST- 2019/05/06 06:00 [pubmed]
PHST- 2019/10/28 06:00 [medline]
PHST- 2019/05/04 06:00 [entrez]
AID - S1201-9712(19)30194-8 [pii]
AID - 10.1016/j.ijid.2019.04.023 [doi]
PST - ppublish
SO  - Int J Infect Dis. 2019 Aug;85S:S18-S25. doi: 10.1016/j.ijid.2019.04.023. Epub 
      2019 Apr 30.