PMID- 19666152
OWN - NLM
STAT- MEDLINE
DCOM- 20091105
LR  - 20090928
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 27
IP  - 43
DP  - 2009 Oct 9
TI  - A novel mammalian cell-culture technique for consistent production of a 
      well-tolerated and immunogenic trivalent subunit influenza vaccine.
PG  - 6022-9
LID - 10.1016/j.vaccine.2009.07.083 [doi]
AB  - Conventional influenza vaccine production methods have limitations due to their 
      reliance on chicken eggs. We evaluated whether a mammalian cell-culture system 
      could reliably produce an influenza vaccine with favourable tolerability and 
      immunogenicity profiles. Adult subjects (n=1200; 18-60 years of age) were 
      randomized (2:2:2:1) to receive either one of three lots of a 
      cell-culture-derived influenza vaccine (CCIV) or an egg-based trivalent 
      inactivated influenza vaccine (TIV). Safety and reactogenicity were assessed 
      using solicited indicators for 7 days post-vaccination, all other adverse events 
      (AEs) were recorded for 21 days post-vaccination, and all serious AEs and AEs 
      necessitating a physician's visit, and/or resulting in subject's withdrawal from 
      the study, were collected for up to 6 months post-vaccination. Antibody titres 
      were measured by haemagglutination inhibition (HI) assay using egg-based viral 
      antigens. All three lots of CCIV had similar safety and tolerability profiles, 
      analogous to those of the TIV. Lot-to-lot consistency was statistically 
      demonstrated through bioequivalence for immunogenicity. Antibody titres assessed 
      at 6 months demonstrated good persistence. This Phase III trial is the first to 
      demonstrate lot-to-lot bioequivalence of a CCIV and persistence of immunogenicity 
      in comparison with a TIV.
FAU - Ambrozaitis, Arvydas
AU  - Ambrozaitis A
AD  - Vilnius University, Vilnius, Lithuania.
FAU - Groth, Nicola
AU  - Groth N
FAU - Bugarini, Roberto
AU  - Bugarini R
FAU - Sparacio, Vittoria
AU  - Sparacio V
FAU - Podda, Audino
AU  - Podda A
FAU - Lattanzi, Maria
AU  - Lattanzi M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090808
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral/blood/immunology
MH  - Cell Culture Techniques/*methods
MH  - Female
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Influenza Vaccines/adverse effects/biosynthesis/*immunology
MH  - Influenza, Human/immunology/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Quality Control
MH  - Vaccines, Inactivated/immunology
MH  - Young Adult
EDAT- 2009/08/12 09:00
MHDA- 2009/11/06 06:00
CRDT- 2009/08/12 09:00
PHST- 2009/03/24 00:00 [received]
PHST- 2009/07/16 00:00 [revised]
PHST- 2009/07/22 00:00 [accepted]
PHST- 2009/08/12 09:00 [entrez]
PHST- 2009/08/12 09:00 [pubmed]
PHST- 2009/11/06 06:00 [medline]
AID - S0264-410X(09)01117-7 [pii]
AID - 10.1016/j.vaccine.2009.07.083 [doi]
PST - ppublish
SO  - Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 
      Aug 8.