PMID- 19673652
OWN - NLM
STAT- MEDLINE
DCOM- 20091006
LR  - 20090818
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 200
IP  - 6
DP  - 2009 Sep 15
TI  - Subunit influenza vaccines produced from cell culture or in embryonated chicken 
      eggs: comparison of safety, reactogenicity, and immunogenicity.
PG  - 849-57
LID - 10.1086/605506 [doi]
AB  - BACKGROUND: This study assessed the safety, reactogenicity, and immunogenicity of 
      an injectable cell culture-derived influenza vaccine (CCIV), compared with those 
      of an injectable egg-based trivalent inactivated influenza vaccine (TIV). 
      METHODS: Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) 
      to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines 
      were assessed on the basis of solicited indicators and other adverse events (AEs) 
      within 7 days of vaccination. All serious AEs and those AEs resulting in 
      withdrawal were recorded throughout the study. Antibody titers were determined by 
      the hemagglutination inhibition assay, using egg- and cell-derived antigens. 
      Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) 
      geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and 
      seroconversion rates. RESULTS: There was no clinically relevant difference 
      between the safety and reactogenicity profiles of the 2 vaccines. The 
      immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the 
      basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, 
      seroprotection rates, and seroconversion rates were comparable between the 2 
      vaccines. CONCLUSIONS: The safety, reactogenicity, and immunogenicity of the CCIV 
      and the egg-based TIV are comparable.
FAU - Reisinger, Keith S
AU  - Reisinger KS
AD  - Primary Physician's Research, Pittsburgh, PA, USA.
FAU - Block, Stanley L
AU  - Block SL
FAU - Izu, Allen
AU  - Izu A
FAU - Groth, Nicola
AU  - Groth N
FAU - Holmes, Sandra J
AU  - Holmes SJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Subunit)
SB  - IM
CIN - J Infect Dis. 2009 Sep 15;200(6):835-7. PMID: 19673653
MH  - Adolescent
MH  - Adult
MH  - Animals
MH  - Antibodies, Viral/biosynthesis/blood
MH  - Chick Embryo
MH  - Dogs
MH  - Female
MH  - Humans
MH  - Influenza A Virus, H1N1 Subtype/*immunology
MH  - Influenza A Virus, H3N2 Subtype/*immunology
MH  - Influenza B virus/*immunology
MH  - Influenza Vaccines/*adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Vaccines, Subunit/adverse effects/immunology
MH  - Young Adult
EDAT- 2009/08/14 09:00
MHDA- 2009/10/07 06:00
CRDT- 2009/08/14 09:00
PHST- 2009/08/14 09:00 [entrez]
PHST- 2009/08/14 09:00 [pubmed]
PHST- 2009/10/07 06:00 [medline]
AID - 10.1086/605506 [doi]
PST - ppublish
SO  - J Infect Dis. 2009 Sep 15;200(6):849-57. doi: 10.1086/605506.