patients withAge >= 60 years MedDRA version: 12.0 Level: LLT Classification code 10016790 Term: Flu
Conditions
Interventions
Trade Name: VAXIGRIP
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Influenza vaccines
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 15-
Produ
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years [at the date of study enrollment] 2. Written informed consent 3. Capability to present to all scheduled visits and follow all the procedures of the study 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
Exclusion criteria: 1. Known anaphylactic hypersensitivity reactions to egg proteins (eggs or egg products), chicken proteins, or any other component of the vaccine including traces (formaldehyde, octoxinol 9 (Triton X-100) and neomycin). 2. Acute febrile illness (axillary temperature  37.5C) at enrollment time. 3. Partecipation in another clinical trial within the previous 4 weeks. 4. Planned participation in another clinical trial in the same period of this study. 5. Current alcohol abuse or addiction to drugs that might interfere with the capability of the subject to follow the procedures of the study. 6. Previous influenza vaccination (within 6 months) with the same formulations upon study or other formulations. 7. Subject deprived of his liberty by administrative order or tribunal, or requiring emergency aid or hospitalized without his consent. 8. Any clinical condition which, in the opinion of the investigator, might interfere with conduction or completion of the study. 9. Subject with any condition which, in the opinion of the investigator, might interfere with the assessment of the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: On field assessment of the safety and the tolerability of a new influenza vaccine, Intanza Sanofi Pasteur, in a cohort of subjects >= 60 years. Assessment of the immunogenicity and ability of intradermal influenza vaccine to elicit an effective antibody response against circulating viruses presenting different antigenic pattern respect to that of vaccine strains. Assessment of the acceptability of the new vaccine Intanza by the users. Assessment of the compliance with vaccination with the new preparation Intanza by the physicians.;Secondary Objective: None;Primary end point(s): On field assessment of the safety and the tolerability of a new influenza vaccine, Intanza Sanofi Pasteur, in a cohort of subjects ≥ 60 years. Assessment of the immunogenicity and ability of intradermal influenza vaccine to elicit an effective antibody response against circulating viruses presenting different antigenic pattern respect to that of vaccine strains. Assessment of the acceptability of the new vaccine Intanza by the users. Assessment of the compliance with vaccination with the new preparation Intanza by the physicians. | — |
Countries
Italy
Outcome results
None listed