Influenza
Conditions
Keywords
safety, Influenza, vaccine, reactogenicity, swine flu
Brief summary
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
Collaborator: Medicines and Healthcare products Regulatory Agency
Interventions
OTHERSafety follow up
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medically-attended adverse events | Within one month after any dose |
Secondary
| Measure | 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) |
Countries
United Kingdom
Outcome results
None listed