Immunogenicity of the Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly.

• Conditions: Vaccination of elderly subjects aged 60 years and over with inactivated, split-virion influenza vaccine administered by the intradermal route using Vaxigrip® as IM reference vaccine.

• Registration Number: EUCTR2006-002366-18-BE
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-27
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3655

Inclusion Criteria

1) Aged over 60 years on the day of inclusion
2) Informed Consent Form signed
3) Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

1) Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxynol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
2) Febrile illness (oral temperature = 37.5°C or rectal equivalent temperature = 38.0°C) on the day of inclusion
3) Participation in another clinical trial in the four weeks preceding the first trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
6) Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion
7) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
8) Blood or blood-derived products received in the past 3 months
9) Any vaccination in the 4 weeks preceding the first trial vaccination
10) Vaccination planned in the 4 weeks following the first trial vaccination
11) Previous vaccination against influenza (in the previous 6 months) with the trial vaccine or another vaccine
12) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Study & Design

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