Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine

An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older

Primary objective:

* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

• Immunogenicity

  • To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
  • To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects

• Safety

  - To describe the safety profile after vaccination in each group

• Acceptability

  • To describe the pain at the injection site
  • To describe the comfort of the injection

Inclusion Criteria:

• Aged 65 years or older on the day of inclusion

Exclusion Criteria:

• Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
• Unstable chronic illness
• Congenital or acquired immunodeficiency,
• Any blood or blood-derived product in the past 3 months
• Current abuse of alcohol or drug addiction
• Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
• Any vaccination against influenza in the past 6 months
• Subjects who previously received a vaccination against influenza by intradermal route