Influenza Clinical Trial
— H1N1 PASS UKOfficial title:
Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)
| Verified date | January 2018 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 9206 |
| Est. completion date | April 6, 2011 |
| Est. primary completion date | October 20, 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | Somerset |
| 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 | Blackburn | Lancashire |
| 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 | Cambridge | Cambridgeshire |
| United Kingdom | GSK Investigational Site | Canterbury | Kent |
| 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 | Frome | Somerset |
| United Kingdom | GSK Investigational Site | Gosport | |
| United Kingdom | GSK Investigational Site | Hanworth, Feltham | |
| United Kingdom | GSK Investigational Site | Harrogate | |
| United Kingdom | GSK Investigational Site | Harwood, Bolton | |
| United Kingdom | GSK Investigational Site | Hertfordshire | |
| United Kingdom | GSK Investigational Site | High Kelling,Holt,Norfolk | |
| United Kingdom | GSK Investigational Site | Honiton,Devon | |
| United Kingdom | GSK Investigational Site | Hoyland, Barnsley | |
| United Kingdom | GSK Investigational Site | Hurstpierpoint, West Sussex | |
| United Kingdom | GSK Investigational Site | Kent, Sevenoaks | |
| 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 | Langport, Somerset | |
| United Kingdom | 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 | 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 | GSK Investigational Site | Norwich, Norfolk | |
| United Kingdom | GSK Investigational Site | 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 | Watford | Hertfordshire |
| United Kingdom | GSK Investigational Site | Wellingborough | Northamptonshire |
| United Kingdom | GSK Investigational Site | Western Approach,Plymouth | |
| United Kingdom | GSK Investigational Site | Westhoughton, Bolton | |
| United Kingdom | GSK Investigational Site | Wiltshire | |
| United Kingdom | GSK Investigational Site | Wiltshire, Westbury | |
| United Kingdom | GSK Investigational Site | Windemere,Cumbria | |
| United Kingdom | GSK Investigational Site | Wokingham, Berkshire | |
| United Kingdom | GSK Investigational Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United Kingdom,
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). pii: e001912. doi: 10.1136/bmjopen-2012-001912. Print 2013. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Medically-attended adverse events | Within one month after any dose | ||
| Secondary | Adverse events solicited to assess reactogenicity | Within seven days after any dose | ||
| Secondary | 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 | ||
| Secondary | Pregnancy outcomes | Within two months after vaccination (last menstrual period up to 45 days after any dose) |
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