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.
Collaborator: Medicines and Healthcare products Regulatory Agency
Study Type
OBSERVATIONAL
Enrollment
9,206
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.
Medically-attended adverse events
Time frame: Within one month after any dose
Adverse events solicited to assess reactogenicity
Time frame: Within seven days after any dose
Serious adverse events and adverse events of special interest
Time frame: Within six months after the second vaccine dose or within a maximum of eight months after the first dose
Pregnancy outcomes
Time frame: Within two months after vaccination (last menstrual period up to 45 days after any dose)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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