Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
NCT ID: NCT00996853
Last Updated: 2018-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
9206 participants
OBSERVATIONAL
2009-10-31
2011-04-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total vaccinated cohort
The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Child in care
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Leicester, , United Kingdom
GSK Investigational Site
Lichfield, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom
GSK Investigational Site
Watford, Hertfordshire, United Kingdom
GSK Investigational Site
Canterbury, Kent, United Kingdom
GSK Investigational Site
Blackburn, Lancashire, United Kingdom
GSK Investigational Site
Wellingborough, Northamptonshire, United Kingdom
GSK Investigational Site
Bath, Somerset, United Kingdom
GSK Investigational Site
Frome, Somerset, United Kingdom
GSK Investigational Site
Addlestone,Surrey, , United Kingdom
GSK Investigational Site
Attleborough, Norfolk, , United Kingdom
GSK Investigational Site
Axbridge, Somerset, , United Kingdom
GSK Investigational Site
Baldock, Herts, , United Kingdom
GSK Investigational Site
Balham, London, , United Kingdom
GSK Investigational Site
Bath, Avon, , United Kingdom
GSK Investigational Site
Bath, Somerset, , United Kingdom
GSK Investigational Site
Bedwell Crescent, Stevenage, , United Kingdom
GSK Investigational Site
Blenheim Walk, Leeds, , United Kingdom
GSK Investigational Site
Botesdale, , United Kingdom
GSK Investigational Site
Boughton, King's Lynn, , United Kingdom
GSK Investigational Site
Bristol, Avon, , United Kingdom
GSK Investigational Site
Bromsgrove,Worcestershire, , United Kingdom
GSK Investigational Site
Chard, Somerset, , United Kingdom
GSK Investigational Site
Chesterfield, , United Kingdom
GSK Investigational Site
Colchester,Essex, , United Kingdom
GSK Investigational Site
Comberton,Cambridge, , United Kingdom
GSK Investigational Site
Darlington, Co. Durham, , United Kingdom
GSK Investigational Site
Devon, , United Kingdom
GSK Investigational Site
Didcot,Oxfordshire, , United Kingdom
GSK Investigational Site
Doncaster, , United Kingdom
GSK Investigational Site
Ecclesfield, , United Kingdom
GSK Investigational Site
Ellesmere Port,Cheshire, , United Kingdom
GSK Investigational Site
Escrick, York, , United Kingdom
GSK Investigational Site
Essex, , United Kingdom
GSK Investigational Site
Fleetwood, , United Kingdom
GSK Investigational Site
Gosport, , United Kingdom
GSK Investigational Site
Hanworth, Feltham, , United Kingdom
GSK Investigational Site
Harrogate, , United Kingdom
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Harwood, Bolton, , United Kingdom
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Hertfordshire, , United Kingdom
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High Kelling,Holt,Norfolk, , United Kingdom
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Honiton,Devon, , United Kingdom
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Hoyland, Barnsley, , United Kingdom
GSK Investigational Site
Hurstpierpoint, West Sussex, , United Kingdom
GSK Investigational Site
Kent, Sevenoaks, , United Kingdom
GSK Investigational Site
Langport, Somerset, , United Kingdom
GSK Investigational Site
Kettering,Kettering, , United Kingdom
GSK Investigational Site
Kippax,Leeds, , United Kingdom
GSK Investigational Site
Lambeth, London, , United Kingdom
GSK Investigational Site
Lancashire, , United Kingdom
GSK Investigational Site
Lancaster, , United Kingdom
GSK Investigational Site
Lutterworth, Leicestershire, , United Kingdom
GSK Investigational Site
Mossley, Ashton Under Lyne, , United Kingdom
GSK Investigational Site
Nantwich, Cheshire, , United Kingdom
GSK Investigational Site
Norwich, Norfolk, , United Kingdom
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Norwich, Norfolk, , United Kingdom
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Nottingham, , United Kingdom
GSK Investigational Site
Orton Goldhay, Peterborough, , United Kingdom
GSK Investigational Site
Oxfordshire, , United Kingdom
GSK Investigational Site
Paiginton, Devon, , United Kingdom
GSK Investigational Site
Radstock, Bath, , United Kingdom
GSK Investigational Site
Romsey, Hampshire, , United Kingdom
GSK Investigational Site
Rowlands Castle, , United Kingdom
GSK Investigational Site
Ruislip, , United Kingdom
GSK Investigational Site
Runcorn, Cheshire, , United Kingdom
GSK Investigational Site
Salisbury, Hampshire, , United Kingdom
GSK Investigational Site
Sedgefield, , United Kingdom
GSK Investigational Site
Shipston-on-Stour, Warwickshire, , United Kingdom
GSK Investigational Site
Somerset, , United Kingdom
GSK Investigational Site
Southbourne, Hampshire, , United Kingdom
GSK Investigational Site
Southsea, Hampshire, , United Kingdom
GSK Investigational Site
Stowmarket,Suffolk, , United Kingdom
GSK Investigational Site
Sunderland, , United Kingdom
GSK Investigational Site
Sway, Hampshire, , United Kingdom
GSK Investigational Site
Swindon, Wiltshire, , United Kingdom
GSK Investigational Site
Tadworth,Surrey, , United Kingdom
GSK Investigational Site
Tarporley,Cheshire, , United Kingdom
GSK Investigational Site
Thornbury, Bristol, , United Kingdom
GSK Investigational Site
Wandsford, Peterborough, , United Kingdom
GSK Investigational Site
Wantage, , United Kingdom
GSK Investigational Site
Wantage, Oxon, , United Kingdom
GSK Investigational Site
Western Approach,Plymouth, , United Kingdom
GSK Investigational Site
Westhoughton, Bolton, , United Kingdom
GSK Investigational Site
Wiltshire, Westbury, , United Kingdom
GSK Investigational Site
Wiltshire, , United Kingdom
GSK Investigational Site
Windemere,Cumbria, , United Kingdom
GSK Investigational Site
Wokingham, Berkshire, , United Kingdom
GSK Investigational Site
York, , United Kingdom
Countries
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References
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Nazareth I, Tavares F, Rosillon D, Haguinet F, Bauchau V. Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a prospective cohort study. BMJ Open. 2013 Feb 5;3(2):e001912. doi: 10.1136/bmjopen-2012-001912. Print 2013.
Tavares F, Nazareth I, Monegal JS, Kolte I, Verstraeten T, Bauchau V. Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: a prospective cohort study. Vaccine. 2011 Aug 26;29(37):6358-65. doi: 10.1016/j.vaccine.2011.04.114. Epub 2011 May 17.
Other Identifiers
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113585
Identifier Type: -
Identifier Source: org_study_id
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