Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Observational Study of Safety and Effectiveness Following Administration of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

Conditions
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Influenza A (H1N1)

Intervention / Treatment
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* Other: This is non-intervention observational study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 6-23 months<br> | Other: This is non-intervention observational study<br>* This is non-intervention observational study<br>|
| 2-8 years<br> | Other: This is non-intervention observational study<br>* This is non-intervention observational study<br>|
| 9-17 years<br> | Other: This is non-intervention observational study<br>* This is non-intervention observational study<br>|
| 18-44 years<br> | Other: This is non-intervention observational study<br>* This is non-intervention observational study<br>|
| 45-60 years<br> | Other: This is non-intervention observational study<br>* This is non-intervention observational study<br>|
| >60 years<br> | Other: This is non-intervention observational study<br>* This is non-intervention observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Swine Flu A (H1N1) vaccine, Adjuvanted flu egg derived, Novel influenza A (H1N1): a new flu virus of swine origin