PMID- 32404782
OWN - NLM
STAT- MEDLINE
DCOM- 20210715
LR  - 20221005
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Print)
IS  - 0891-3668 (Linking)
VI  - 39
IP  - 8
DP  - 2020 Aug
TI  - Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza 
      Vaccine in Young Children at High Risk of Influenza-associated Complications: A 
      Phase III, Randomized, Observer-blind, Multicenter Clinical Trial.
PG  - e185-e191
LID - 10.1097/INF.0000000000002727 [doi]
AB  - BACKGROUND: Vaccination against seasonal influenza is recommended for all 
      children with a history of medical conditions placing them at increased risk of 
      influenza-associated complications. The immunogenicity and efficacy of 
      conventional influenza vaccines among young children are suboptimal; one strategy 
      to enhance these is adjuvantation. We present immunogenicity and safety data for 
      an MF59-adjuvanted quadrivalent influenza vaccine (aIIV4) in healthy children and 
      those at a high risk of influenza-associated complications, based on the results 
      of a recently completed phase III study. METHODS: Children 6 months to 5 years of 
      age (N = 10,644) were enrolled. The study was conducted across northern 
      hemisphere seasons 2013-2014 and 2014-2015. Subjects received either aIIV4 or a 
      nonadjuvanted comparator influenza vaccine. Antibody responses were assessed by 
      hemagglutination inhibition assay against vaccine and heterologous strains. 
      Long-term antibody persistence was assessed (ClinicalTrials.gov: NCT01964989). 
      RESULTS: aIIV4 induced significantly higher antibody titers than nonadjuvanted 
      vaccine in high-risk subjects. aIIV4 antibody responses were of similar magnitude 
      in high-risk and healthy subjects. Incidence of solicited local and systemic 
      adverse events (AEs) was slightly higher in aIIV4 than nonadjuvanted vaccinees, 
      in both the healthy and high-risk groups. Incidence of unsolicited AEs, serious 
      AEs and AEs of special interest were similar for adjuvanted and nonadjuvanted 
      vaccinees in the healthy and high-risk groups. CONCLUSION: aIIV4 was more 
      immunogenic than nonadjuvanted vaccine in both the healthy and high-risk study 
      groups. The reactogenicity and safety profiles of aIIV4 and the nonadjuvanted 
      vaccine were acceptable and similar in 6-month- to 5-year-old high-risk and 
      healthy children.
FAU - Esposito, Susanna
AU  - Esposito S
AD  - From the Pediatric Clinic, Department of Surgical and Biomedical Sciences, 
      Universita degli Studi di Perugia, Perugia, Italy.
FAU - Fling, John
AU  - Fling J
AD  - Department of Pediatrics, Health Science Center, University of North Texas, Fort 
      Worth, TX.
FAU - Chokephaibulkit, Kulkanya
AU  - Chokephaibulkit K
AD  - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - de Bruijn, Marianne
AU  - de Bruijn M
AD  - Seqirus Netherlands B.V., Amsterdam, The Netherlands.
FAU - Oberye, Janine
AU  - Oberye J
AD  - Seqirus Netherlands B.V., Amsterdam, The Netherlands.
FAU - Zhang, Bin
AU  - Zhang B
AD  - Seqirus USA Inc., Cambridge, MA.
FAU - Vossen, Jeanique
AU  - Vossen J
AD  - Seqirus Netherlands B.V., Amsterdam, The Netherlands.
FAU - Heijnen, Esther
AU  - Heijnen E
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Smolenov, Igor
AU  - Smolenov I
AD  - Seqirus USA Inc., Cambridge, MA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01964989
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 7QWM220FJH (Squalene)
SB  - IM
MH  - Adjuvants, Immunologic/*administration & dosage
MH  - Antibodies, Viral/*blood
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - Infant
MH  - Influenza A Virus, H1N1 Subtype/immunology
MH  - Influenza Vaccines/administration & dosage/*immunology
MH  - Influenza, Human/complications/*prevention & control
MH  - Male
MH  - Polysorbates/*administration & dosage
MH  - Risk Factors
MH  - Seasons
MH  - Squalene/*administration & dosage/immunology
PMC - PMC7360101
COIS- M.d.B., J.O., B.Z., J.V. and I.S. are all currently permanent employees of the 
      Seqirus group of companies. E.H. was a permanent employee of Novartis Vaccines 
      B.V. at the time of the study. The other authors have no conflicts of interest to 
      disclose.
EDAT- 2020/05/15 06:00
MHDA- 2021/07/16 06:00
PMCR- 2020/07/14
CRDT- 2020/05/15 06:00
PHST- 2020/05/15 06:00 [pubmed]
PHST- 2021/07/16 06:00 [medline]
PHST- 2020/05/15 06:00 [entrez]
PHST- 2020/07/14 00:00 [pmc-release]
AID - 00006454-202008000-00024 [pii]
AID - 10.1097/INF.0000000000002727 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2020 Aug;39(8):e185-e191. doi: 
      10.1097/INF.0000000000002727.