Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom

Study Overview
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Brief Summary
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The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation of safety data. This study is a commitment to the European Medicines Agency (EMEA), as part of GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza vaccination.

Detailed Description
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Collaborator: Medicines and Healthcare products Regulatory Agency

Official Title
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Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)

Conditions
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Influenza

Intervention / Treatment
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* Other: Safety follow up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent, and assent where appropriate, obtained from the subject/from the subject's parent(s)/ Legally Acceptable Representative(s) (LAR). A male or female subject vaccinated with a first dose of GSK Biologicals' H1N1 pandemic influenza vaccine shortly (<24h) before being recruited in the study, and within a GP practice participating in the study and where the subject is registered. Subjects who the Investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol Exclusion Criteria: Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment. Child in care
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 |
| --- | --- |
| Total vaccinated cohort<br>The Total vaccinated cohort will include all subjects with at least one vaccine administration documented. | Other: Safety follow up<br>* Collection of reactogenicity data from diary cards, reporting of medically-attended adverse events, reporting of serious adverse events and adverse events of special interest, reporting of pregnancy outcomes and fatalities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medically-attended adverse events |  | Within one month after any dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events solicited to assess reactogenicity |  | Within seven days after any dose | 
| Serious adverse events and adverse events of special interest |  | Within six months after the second vaccine dose or within a maximum of eight months after the first dose | 
| Pregnancy outcomes |  | Within two months after vaccination (last menstrual period up to 45 days after any dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, Influenza, vaccine, reactogenicity, swine flu