PMID- 34960214
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211231
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 9
IP  - 12
DP  - 2021 Dec 11
TI  - Analyses of Safety Profile and Homologous Antibody Responses to a Mammalian 
      Cell-Based, MF59-Adjuvanted, A/H5N1, Pandemic Influenza Vaccine across Four Phase 
      II/III Clinical Trials in Healthy Children, Adults, and Older Adults.
LID - 10.3390/vaccines9121468 [doi]
LID - 1468
AB  - Modern cell culture-based technology eliminates vaccine manufactures reliance on 
      embryonated chicken eggs, which may become compromised during an avian influenza 
      pandemic. Four studies (total N = 6230) assessed the immunogenicity and safety of 
      mammalian cell-based, MF59((R))-adjuvanted, A/H5N1 vaccine (aH5N1c; AUDENZ) as two 
      doses administered on Days 1 and 22 in children (NCT01776554), adults 
      (NCT01776541; NCT02839330), and older adults (NCT01766921; NCT02839330). 
      Immunogenicity of formulations at 7.5 mug and 3.75 mug antigen per dose were 
      assessed by hemagglutination inhibition and microneutralization assays on Days 1, 
      22, 43, and 183 or 387. Solicited local and systemic adverse events (AEs) were 
      recorded for 7 days after each vaccination. Unsolicited AEs were collected for 21 
      days after each vaccination, and serious and other selected AEs were recorded for 
      one year. Antibody responses after two 7.5 mug doses met CBER licensure criteria 
      in all age groups. Overall, an age-related response was evident, with the highest 
      responses observed in children <3 years old. In children, antibody titers met 
      seroconversion criteria 12 months after vaccination. MF59 allowed for antigen 
      dose sparing. Solicited AEs were mild to moderate in nature, of short duration, 
      and less frequent after the second dose than the first, demonstrating a favorable 
      risk-benefit profile.
FAU - Versage, Eve
AU  - Versage E
AD  - Seqirus USA Inc., Cambridge, MA 02139, USA.
FAU - van Twuijver, Esther
AU  - van Twuijver E
AUID- ORCID: 0000-0001-6493-3393
AD  - Seqirus Netherlands B.V., 1105 BJ Amsterdam, The Netherlands.
FAU - Jansen, Wim
AU  - Jansen W
AD  - Seqirus Netherlands B.V., 1105 BJ Amsterdam, The Netherlands.
FAU - Theeuwes, Ad
AU  - Theeuwes A
AD  - Seqirus Netherlands B.V., 1105 BJ Amsterdam, The Netherlands.
FAU - Sawlwin, Daphne
AU  - Sawlwin D
AD  - Seqirus Pty Ltd., Melbourne 3052, Australia.
FAU - Hohenboken, Matthew
AU  - Hohenboken M
AD  - Seqirus USA Inc., Cambridge, MA 02139, USA.
LA  - eng
PT  - Journal Article
DEP - 20211211
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC8704792
OTO - NOTNLM
OT  - H5N1
OT  - MF59
OT  - adjuvant
OT  - cell culture
OT  - influenza
OT  - pandemic
OT  - vaccine
COIS- Authors E.V., E.v.T., W.J., A.T., D.S. and M.H. are employees of the Seqirus 
      group of companies.
EDAT- 2021/12/29 06:00
MHDA- 2021/12/29 06:01
PMCR- 2021/12/11
CRDT- 2021/12/28 01:06
PHST- 2021/09/07 00:00 [received]
PHST- 2021/11/16 00:00 [revised]
PHST- 2021/12/07 00:00 [accepted]
PHST- 2021/12/28 01:06 [entrez]
PHST- 2021/12/29 06:00 [pubmed]
PHST- 2021/12/29 06:01 [medline]
PHST- 2021/12/11 00:00 [pmc-release]
AID - vaccines9121468 [pii]
AID - vaccines-09-01468 [pii]
AID - 10.3390/vaccines9121468 [doi]
PST - epublish
SO  - Vaccines (Basel). 2021 Dec 11;9(12):1468. doi: 10.3390/vaccines9121468.