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A phase IIb, controlled, randomised, multicenter, observer blinded study to demonstrate the lot-to-lot consistency of three consecutive production lots of low dose of influenza vaccine adjuvanted with...

Update Il y a 5 ans
Reference: EUCTR2006-001169-40

A phase IIb, controlled, randomised, multicenter, observer blinded study to demonstrate the lot-to-lot consistency of three consecutive production lots of low dose of influenza vaccine adjuvanted with AS03, and to evaluate the safety of low dose of influenza vaccine adjuvanted with AS03 compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly 60 years and older

Woman and Man

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Extract

•To demonstrate the lot-to-lot consistency of 3 lots of the low dose adjuvanted (AS03) influenza vaccine in terms of immunogenicity, 21 days after vaccination. •To assess the safety and reactogenicity in elderly subjects >60 years old vaccinated with low dose adjuvanted (AS03) influenza vaccine and Fluarix, during the entire study period.

Inclusion criteria

  • Immunization against influenza in male and female subjects aged 60 years and older

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