Influenza Clinical Trial
Official title:
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
n/a
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