Immunogenicity of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with Intramuscular Vaccination with Vaxigrip® in Adults.
- Conditions
- Annual vaccination of healthy adult (18-60 years) for 3 consecutive years.Classification code 10036897
- Registration Number
- EUCTR2005-002401-23-BE
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 978
1) Aged 18 to 57 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
4) For a woman, inability to bear a child or negative urine pregnancy test at V01
5) For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least four weeks after the first vaccination
6) Addendum to the informed consent form signed and dated by the subject prior to vaccination at V05
7) Addendum to the informed consent form signed and dated by the subject prior to vaccination at V07
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) no
F.1.3.1 Number of subjects for this age range
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 (rectal equivalent temperature =38.0°C) on the day of inclusion
3) Breast-feeding
4) Participation in another clinical trial in the four weeks preceding the first trial vaccination
5) Planned participation in another clinical trial during the present trial period
6) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroid therapy
7) Chronic illness at a stage that could interfere with trial conduct or completion
8) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
9) Blood or blood-derived products received in the past three months
10) Any vaccination in the four weeks preceding the first trial vaccination
11) Vaccination planned in the four weeks following the first trial vaccination
12) Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
13) Thrombocytopenia or bleeding disorder contraindicating IM vaccination
14) 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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that the vaccine administered by the intradermal (ID) route with the new Becton Dickinson (BD) ID system (pre-filled ID system allowing a better ergonomic use) is at least as immunogenic as the administration of the vaccine by the intramuscular (IM) route after the first vaccination. ;Secondary Objective: - To describe the safety profile after each vaccine administration.<br>- To describe the effect of the repetition of ID injections and of the interchangeability of ID/IM and IM/ID injections on the safety profile.<br>- To describe the anti-HA antibody persistence after the first injection (at Month 3 [M3], M6 and M12).<br>- To describe the compliance of the immunogenicity of the ID study vaccine with the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) after the first injection. ;Primary end point(s): Anti-HA antibody titers for the three strains obtained on Day 21 (D21) after the first vaccination
- Secondary Outcome Measures
Name Time Method