PMID- 17724151
OWN - NLM
STAT- MEDLINE
DCOM- 20080115
LR  - 20181113
IS  - 0066-4804 (Print)
IS  - 1098-6596 (Electronic)
IS  - 0066-4804 (Linking)
VI  - 51
IP  - 11
DP  - 2007 Nov
TI  - Comparative immunogenicities of frozen and refrigerated formulations of live 
      attenuated influenza vaccine in healthy subjects.
PG  - 4001-8
AB  - The frozen version of live attenuated influenza vaccine (LAIV; FluMist) was 
      compared with a newly licensed, refrigerated formulation, the cold-adapted 
      influenza vaccine, trivalent (CAIV-T), for their immunogenicity, safety, and 
      tolerability in healthy subjects 5 to 49 years of age. Eligible subjects were 
      randomized 1:1 to receive CAIV-T or frozen LAIV. Subjects 5 to 8 years of age 
      received two doses of vaccine 46 to 60 days apart; subjects 9 to 49 years of age 
      received one dose of vaccine. Equivalent immunogenicities were defined as serum 
      hemagglutination inhibition (HAI) geometric mean titer (GMT) ratios >0.5 and <2.0 
      for each of the three vaccine-specific strains. A total of 376 subjects 5 to 8 
      years of age and 566 subjects 9 to 49 years of age were evaluable. 
      Postvaccination HAI GMT ratios were equivalent for CAIV-T and LAIV. The GMT 
      ratios of CAIV-T/LAIV for the H1N1, H3N2, and B strains were 1.24, 1.02, and 
      1.00, respectively, for the 5- to 8-year-old age group and 1.14, 1.12, and 0.96, 
      respectively, for the 9- to 49-year-old age group. Seroresponse/seroconversion 
      rates (fourfold or greater rise) were similar in both age groups for each of the 
      three vaccine strains. Within 28 days, the most frequent reactogenicity event in 
      the CAIV-T and LAIV groups was runny nose/nasal congestion, which occurred at 
      higher rates after dose 1 (44% and 42%, respectively) than after dose 2 (41% and 
      29%, respectively) in the 5- to 8-year-old group. Otherwise, the rates of adverse 
      events (AEs) were similar between the treatment groups and the two age cohorts, 
      with no serious AEs related to the study vaccines. The immunogenicities, 
      reactogenicity events, and AEs were comparable for refrigerated CAIV-T and frozen 
      LAIV.
FAU - Block, Stan L
AU  - Block SL
AD  - Kentucky Pediatric Research, 201 S. 5th St., Bardstown, KY 40004-1142, USA. 
      slblock@pol.net
FAU - Reisinger, Keith S
AU  - Reisinger KS
FAU - Hultquist, Micki
AU  - Hultquist M
FAU - Walker, Robert E
AU  - Walker RE
CN  - CAIV-T Study Group
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 - 20070827
PL  - United States
TA  - Antimicrob Agents Chemother
JT  - Antimicrobial agents and chemotherapy
JID - 0315061
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Cold Temperature
MH  - Double-Blind Method
MH  - Female
MH  - Freezing
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Immunization Schedule
MH  - Influenza Vaccines/administration & dosage/adverse effects/*immunology
MH  - Male
MH  - Middle Aged
MH  - Vaccination/adverse effects/methods
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/*immunology
PMC - PMC2151446
EDAT- 2007/08/29 09:00
MHDA- 2008/01/16 09:00
PMCR- 2008/03/01
CRDT- 2007/08/29 09:00
PHST- 2007/08/29 09:00 [pubmed]
PHST- 2008/01/16 09:00 [medline]
PHST- 2007/08/29 09:00 [entrez]
PHST- 2008/03/01 00:00 [pmc-release]
AID - AAC.00517-07 [pii]
AID - 0517-07 [pii]
AID - 10.1128/AAC.00517-07 [doi]
PST - ppublish
SO  - Antimicrob Agents Chemother. 2007 Nov;51(11):4001-8. doi: 10.1128/AAC.00517-07. 
      Epub 2007 Aug 27.