PMID- 28925801
OWN - NLM
STAT- MEDLINE
DCOM- 20190104
LR  - 20240315
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 2
DP  - 2018 Feb 1
TI  - MF59-adjuvanted influenza vaccine (FLUAD(R)) elicits higher immune responses than a 
      non-adjuvanted influenza vaccine (Fluzone(R)): A randomized, multicenter, Phase III 
      pediatric trial in Mexico.
PG  - 386-395
LID - 10.1080/21645515.2017.1373227 [doi]
AB  - The poor immune response elicited by trivalent influenza vaccines (TIVs) in 
      children can be enhanced by the addition of adjuvants. This observer-blind, 
      randomized Phase III trial assessed the immunogenicity and safety of the 
      MF59-adjuvanted trivalent influenza vaccine FLUAD(R) (aTIV) and a non-adjuvanted 
      TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during 
      the 2014-2015 season. The primary objectives were to assess the non-inferiority 
      of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV 
      and TIV. Seroconversion was one of several secondary objectives. In total, 287 
      children were enrolled. The non-inferiority criteria for GMTs and seroconversion 
      were met for aTIV for all 3 vaccine strains. Lower bounds of the 95% confidence 
      intervals for all 3 aTIV:TIV vaccine ratios were >2, showing that the 
      immunogenicity of aTIV was superior to that of TIV for all 3 strains. Solicited 
      adverse events (AEs) were experienced more frequently with aTIV than TIV by 
      younger children (aged 6 to <36 months), but were more frequent with TIV than 
      aTIV in older children (aged 36 to <72 months) who had been vaccinated 
      previously. More unsolicited AEs were associated with aTIV than the TIV. All AEs 
      were of mild or moderate severity. No deaths, serious AEs, or AEs leading to 
      premature withdrawal were reported. Overall, aTIV was highly immunogenic and was 
      well tolerated in healthy children 6 to <72 months of age. These results indicate 
      that aTIV may be a beneficial addition to national pediatric vaccination 
      programs.
FAU - Cruz-Valdez, Aurelio
AU  - Cruz-Valdez A
AD  - a Center of Investigation of Public Health, National Institute of Public Health , 
      Cuernavaca , Morelos , Mexico.
FAU - Valdez-Zapata, Gabriel
AU  - Valdez-Zapata G
AD  - b Department of Pediatric Investigation , UNAMIS , Merida , Yucatan , Mexico.
FAU - Patel, Sanjay S
AU  - Patel SS
AD  - c Influenza Vaccines Development, Novartis Influenza Vaccines , Cambridge , MA , 
      USA.
FAU - Castelli, Flavia V
AU  - Castelli FV
AD  - d Vaccines R&D, GSK , Bs.As. , Argentina.
FAU - Garcia, Marcia G
AU  - Garcia MG
AD  - e Vaccines R&D, GSK , Mexico City , Mexico.
FAU - Jansen, Wim T
AU  - Jansen WT
AD  - f Department of BioStatistics GSK , Amsterdam , The Netherlands.
FAU - Arora, Ashwani Kumar
AU  - Arora AK
AD  - g Clinical Development, Novartis Vaccines , Siena , Italy.
FAU - Heijnen, Esther
AU  - Heijnen E
AD  - h Seasonal Influenza Vaccines, Seqirus , Amsterdam , The Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT02255279
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180103
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Indoles)
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF 592)
RN  - 0 (Sulfonylurea Compounds)
SB  - IM
MH  - Adjuvants, Immunologic
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Indoles/*pharmacology
MH  - Infant
MH  - Influenza A Virus, H1N1 Subtype/immunology
MH  - Influenza A Virus, H3N2 Subtype/immunology
MH  - Influenza B virus/immunology
MH  - Influenza Vaccines/administration & dosage/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Mexico/epidemiology
MH  - Sulfonylurea Compounds/*pharmacology
PMC - PMC5806633
OTO - NOTNLM
OT  - MF59
OT  - adjuvant
OT  - immunogenicity
OT  - influenza
OT  - safety
OT  - trivalent influenza vaccine
EDAT- 2017/09/20 06:00
MHDA- 2019/01/05 06:00
PMCR- 2018/01/03
CRDT- 2017/09/20 06:00
PHST- 2017/09/20 06:00 [pubmed]
PHST- 2019/01/05 06:00 [medline]
PHST- 2017/09/20 06:00 [entrez]
PHST- 2018/01/03 00:00 [pmc-release]
AID - 1373227 [pii]
AID - 10.1080/21645515.2017.1373227 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018 Feb 1;14(2):386-395. doi: 
      10.1080/21645515.2017.1373227. Epub 2018 Jan 3.