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 (Addigrip® 15µg) in subjects 65 years of age or older

• Conditions: prevention, vaccination against Influenza in subjects 65 years or older via intradermal route; MedDRA version: 9.1Level: LLTClassification code 10016794Term: Flu vaccination

• Registration Number: EUCTR2007-002861-11-BE
• Lead Sponsor: Sanofi Pasteur MSD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-25
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 790

Inclusion Criteria

Aged 65 years or older on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Febrile illness (oral temperature =37.5°C) on the day of inclusion
Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening adverse reaction to the study vaccine or a vaccine containing the same substances
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Unstable chronic illness (defined as illness requiring hospitalisation or a clinically significant change in medication in the past 12 weeks) at a stage that could interfere with study conduct or completion
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy, or radiation therapy in the past 6 months, or long-term systemic corticosteroids therapy given daily or on alternate days at =20 mg/day prednisone equivalent for 14 days or more
Any blood or blood-derived product (including immunoglobulins) in the past 3 months
Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with study procedures
Any vaccination in the past 4 weeks
Any vaccination planned in the 4 weeks following study vaccination
Any vaccination against influenza in the past 6 months (with the study vaccine or another vaccine)
Subjects who previously received a vaccination against influenza by intradermal route
Participation in another clinical study in the past 4 weeks
Planned participation in another clinical study during the present study period
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent or subject under guardianship, or subject in a social or sanitary establishment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified