Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
Completed
- Conditions
- Influenza A (H1N1)
- Interventions
- Other: This is non-intervention observational study
- Registration Number
- NCT01101074
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135469
Inclusion Criteria
- Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.
Exclusion Criteria
- Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
- Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description >60 years This is non-intervention observational study - 6-23 months This is non-intervention observational study - 2-8 years This is non-intervention observational study - 9-17 years This is non-intervention observational study - 18-44 years This is non-intervention observational study - 45-60 years This is non-intervention observational study -
- Primary Outcome Measures
Name Time Method Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects Within 3 weeks and 6 weeks after vaccine administration
- Secondary Outcome Measures
Name Time Method The occurrence of hospitalization within 6 weeks and 2 years after vaccination in a cohort of subjects vaccinated sw unvaccinated subjects, with Flu Egg Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine 2 years