PMID- 19903213
OWN - NLM
STAT- MEDLINE
DCOM- 20100107
LR  - 20211020
IS  - 1750-2659 (Electronic)
IS  - 1750-2640 (Print)
IS  - 1750-2640 (Linking)
VI  - 3
IP  - 6
DP  - 2009 Nov
TI  - Safety and immunogenicity of an inactivated thimerosal-free influenza vaccine in 
      infants and children.
PG  - 315-25
LID - 10.1111/j.1750-2659.2009.00108.x [doi]
AB  - OBJECTIVE: Few prospective studies of inactivated split virion influenza vaccine 
      have been conducted in infants and children. Our objective was to evaluate the 
      safety, reactogenicity and immunogenicity of a thimerosal-free inactivated 
      influenza vaccine (Fluvax; CSL Limited, Parkville, Australia) in children aged 6 
      months to <9 years. METHODS: A prospective, open-label, phase III clinical trial 
      was conducted in 298 healthy children previously unvaccinated with influenza, 
      commencing in the Southern Hemisphere 2005 autumn. Participants were divided into 
      two groups (Group A: > or =6 months to <3 years; Group B: > or =3 years to <9 
      years), and received two doses of the 2005 vaccine, and one dose of the 2006 
      vaccine one year later (Group A: 0.25 ml per dose; Group B: 0.5 ml per dose). 
      Vaccine safety and reactogenicity was evaluated for 30 days after each dose. 
      Immunogenicity was assessed using hemagglutination inhibition and single radial 
      hemolysis assays. RESULTS: There were no withdrawals due to adverse events (AEs). 
      The majority of solicited local and systemic AEs were of mild severity. A maximum 
      intensity of severe was reported for injection site pain and fever by only 3.0% 
      and 3.4% of participants, respectively. The vaccine was immunogenic for all 
      antigens, with > or =95% of both younger and older children achieving 
      seroprotection after dose 2. CONCLUSIONS: This thimerosal-free inactivated 
      influenza vaccine had a favorable safety profile and was immunogenic in children 
      aged > or =6 months and <9 years. Primary and booster vaccination produced 
      consistently immunogenic responses including in children under 3 years of age 
      receiving 0.25 ml doses of vaccine.
FAU - Nolan, Terry
AU  - Nolan T
AD  - Vaccine and Immunisation Research Group at the Murdoch Children's Research 
      Institute and the Melbourne School of Population Health, University of Melbourne, 
      Victoria 3010, Australia. t.nolan@unimelb.edu.au
FAU - Richmond, Peter C
AU  - Richmond PC
FAU - McVernon, Jodie
AU  - McVernon J
FAU - Skeljo, Maryanne V
AU  - Skeljo MV
FAU - Hartel, Gunter F
AU  - Hartel GF
FAU - Bennet, Jillian
AU  - Bennet J
FAU - Basser, Russell L
AU  - Basser RL
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Influenza Other Respir Viruses
JT  - Influenza and other respiratory viruses
JID - 101304007
RN  - 0 (Antibodies, Viral)
RN  - 0 (Excipients)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
RN  - 2225PI3MOV (Thimerosal)
SB  - IM
MH  - Antibodies, Viral/blood
MH  - Australia
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Excipients/pharmacology
MH  - Female
MH  - Fever/chemically induced
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Immunization, Secondary
MH  - Infant
MH  - Influenza Vaccines/*adverse effects/*immunology
MH  - Influenza, Human/*prevention & control
MH  - Male
MH  - Pain/chemically induced
MH  - Thimerosal/pharmacology
MH  - Vaccines, Inactivated/adverse effects/immunology
PMC - PMC4941394
EDAT- 2009/11/12 06:00
MHDA- 2010/01/08 06:00
PMCR- 2009/11/01
CRDT- 2009/11/12 06:00
PHST- 2009/11/12 06:00 [entrez]
PHST- 2009/11/12 06:00 [pubmed]
PHST- 2010/01/08 06:00 [medline]
PHST- 2009/11/01 00:00 [pmc-release]
AID - IRV108 [pii]
AID - 10.1111/j.1750-2659.2009.00108.x [doi]
PST - ppublish
SO  - Influenza Other Respir Viruses. 2009 Nov;3(6):315-25. doi: 
      10.1111/j.1750-2659.2009.00108.x.