Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated either with an Inactivated Influenza Vaccine Administered via the Intradermal Route or an Inactivated Influenza Vaccine Administered via the Intramuscular Route

Phase 1

• Conditions: Vaccination of adult subjects aged 18 to 40 years and elderly subjects aged 60 to 85 years with an inactivated, split-virion influenza vaccine administered via the intradermal route using Vaxigrip® as IM reference vaccine

• Registration Number: EUCTR2007-002104-18-FR
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-23
• Study Completion: 2008-05-05
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1) Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
2) Provision of a signed informed consent
3) Able to attend all scheduled visits and comply with all trial procedures
4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination
5) Entitlement to national social security

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) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
2) Breast-feeding woman
3) Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) Known or suspected 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) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
10) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
11) Planned receipt of any vaccine in the 4 weeks following the trial vaccination
12) Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
13) Previous vaccination against Influenza in the previous 6 months
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
15) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
16) Febrile illness (oral temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Study & Design

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