Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults

Study Overview
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Brief Summary
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This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring. Primary objective: To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups. Secondary objective: To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.

Detailed Description
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All participants will be vaccinated with study vaccines (1 or 2 doses) at the start of the study and will be monitored for safety for up to 6 months after the last vaccination.

Official Title
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Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations

Conditions
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Influenza, Swine-Origin A/H1N1 Influenza Virus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged 2 months and above on the day of inclusion Having received HUMENZA or PANENZA Provision of the Contact Order Form (COF) signed by the participant or the participant's parent(s)/guardians(s) Participant or the participant's parent(s)/legal representative(s) are able to attend all scheduled visits and to comply with all study procedures Exclusion Criteria : Participant previously vaccinated with another A/H1N1 pandemic vaccine

Ages Eligible for Study
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Minimum Age: 2 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 |
| --- | --- |
| HUMENZA Vaccine Group<br>Participants vaccinated with HUMENZA according to the recommendations provided in the product leaflet and local recommendations. | |
| PANENZA Vaccine Group<br>Participants vaccinated with PANENZA according to the recommendations provided in the product leaflet and local recommendations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines. |  | 21 days post-vaccination and entire study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HUMENZA, PANENZA, Influenza, Swine-Origin Influenza A H1N1 Virus, Influenza virus vaccines