Observational Safety 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 is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

Official Title
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A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Focetria

Conditions
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Pandemic Influenza A (H1N1), A New Flu Virus of Swine Origin

Intervention / Treatment
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* Other: Non-intervention observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age in accordance with the approved product label of the country where the study is conducted Subjects will be vaccinated with Focetria®, independently of this study. Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact Exclusion Criteria: • Received any prior H1N1 vaccination

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 |
| --- | --- |
| Group 1: 6-23 months<br> | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|
| Group 2: 2-8 years<br> | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|
| Group 3: 9-17 years<br> | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|
| Group 4: 18-44 years<br> | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|
| Group 5: 45-60 years<br> | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|
| Group: >60 years<br> | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects. |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pandemic influenza A (H1N1) vaccine, Adjuvanted