Annual vaccination of healthy adult (18-60 years) for 3 consecutive years. Classification code 10036897
Conditions
Interventions
Product Name: Intradermal Influenza Vaccine
Product Code: 333
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza vaccine (A/H3N2 strain)
Concen
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1) 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - 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. - To describe the anti-HA antibody persistence after the first injection (at Month 3 [M3], M6 and M12). - 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 | — |
Countries
Germany
Outcome results
None listed