An observational study in Influenza, sponsored by GlaxoSmithKline. Completed at 91 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2018-01-16.
Sponsored by GlaxoSmithKline · Observational
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
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 9,206 is above the median of 300 across 305 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population studied will include individuals in priority groups currently considered for H1N1 pandemic vaccination. Subjects not pertaining to these priority groups can also be enrolled.
Exclusion Criteria:
The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.
Other: Safety 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.
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 study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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