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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Flu-ID 15μg

Biological: Inactivated adjuvanted Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00554333

FID01C

Details and patient eligibility

About

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

Enrollment

795 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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