Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total vaccinated cohort | The Total vaccinated cohort will include all subjects with at least one vaccine administration documented. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety follow up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medically-attended adverse events | Within one month after any dose |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | Cambridgeshire | CB3 9HS | United Kingdom | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23388195 | Background | 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. | |
| 21596080 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pregnancy outcomes | Within two months after vaccination (last menstrual period up to 45 days after any dose) |
| Watford |
| Hertfordshire |
| WD25 0EA |
| United Kingdom |
| GSK Investigational Site | Canterbury | Kent | CT1 3HX | United Kingdom |
| GSK Investigational Site | Blackburn | Lancashire | BB2 2ST | United Kingdom |
| GSK Investigational Site | Wellingborough | Northamptonshire | NN8 4RW | United Kingdom |
| GSK Investigational Site | Bath | Somerset | BA2 1NH | United Kingdom |
| GSK Investigational Site | Frome | Somerset | BA11 1EZ | United Kingdom |
| GSK Investigational Site | Addlestone,Surrey | KT15 2BH | United Kingdom |
| GSK Investigational Site | Attleborough, Norfolk | NR17 2AS | United Kingdom |
| GSK Investigational Site | Axbridge, Somerset | BS26 2BJ | United Kingdom |
| GSK Investigational Site | Baldock, Herts | SG7 6BP | United Kingdom |
| GSK Investigational Site | Balham, London | SW12 8WU | United Kingdom |
| GSK Investigational Site | Bath, Avon | BA2 4JT | United Kingdom |
| GSK Investigational Site | Bath, Somerset | BA2 4BY | United Kingdom |
| GSK Investigational Site | Bedwell Crescent, Stevenage | SG1 1LQ | United Kingdom |
| GSK Investigational Site | Blenheim Walk, Leeds | LS2 9AE | United Kingdom |
| GSK Investigational Site | Botesdale | IP22 1DW | United Kingdom |
| GSK Investigational Site | Boughton, King's Lynn | PE33 9AG | United Kingdom |
| GSK Investigational Site | Bristol, Avon | BS13 8LD | United Kingdom |
| GSK Investigational Site | Bromsgrove,Worcestershire | B61 8DT | United Kingdom |
| GSK Investigational Site | Chard, Somerset | TA20 1QF | United Kingdom |
| GSK Investigational Site | Chesterfield | S41 8NA | United Kingdom |
| GSK Investigational Site | Colchester,Essex | CO4 9YN | United Kingdom |
| GSK Investigational Site | Comberton,Cambridge | CB23 7DY | United Kingdom |
| GSK Investigational Site | Darlington, Co. Durham | DL3 8SQ | United Kingdom |
| GSK Investigational Site | Devon | EX9 6LS | United Kingdom |
| GSK Investigational Site | Didcot,Oxfordshire | OX11 7JH | United Kingdom |
| GSK Investigational Site | Doncaster | DN9 1EP | United Kingdom |
| GSK Investigational Site | Ecclesfield | S35 9XQ | United Kingdom |
| GSK Investigational Site | Ellesmere Port,Cheshire | CH66 2WW | United Kingdom |
| GSK Investigational Site | Escrick, York | YO19 6LE | United Kingdom |
| GSK Investigational Site | Essex | CO3 4LN | United Kingdom |
| GSK Investigational Site | Fleetwood | FY7 6HD | United Kingdom |
| GSK Investigational Site | Gosport | PO12 3AQ | United Kingdom |
| GSK Investigational Site | Hanworth, Feltham | TW13 6HD | United Kingdom |
| GSK Investigational Site | Harrogate | HG3 5AT | United Kingdom |
| GSK Investigational Site | Harwood, Bolton | BL2 3HQ | United Kingdom |
| GSK Investigational Site | Hertfordshire | SG6 4TS | United Kingdom |
| GSK Investigational Site | High Kelling,Holt,Norfolk | NR25 6QA | United Kingdom |
| GSK Investigational Site | Honiton,Devon | EX14 2NY | United Kingdom |
| GSK Investigational Site | Hoyland, Barnsley | S74 9AF | United Kingdom |
| GSK Investigational Site | Hurstpierpoint, West Sussex | BN6 9UQ | United Kingdom |
| GSK Investigational Site | Kent, Sevenoaks | TN13 3NT | United Kingdom |
| GSK Investigational Site | Kettering,Kettering | NN14 1SN | United Kingdom |
| GSK Investigational Site | Kippax,Leeds | LS25 7JN | United Kingdom |
| GSK Investigational Site | Lambeth, London | SW16 5LS | United Kingdom |
| GSK Investigational Site | Lancashire | BL1 6AP | United Kingdom |
| GSK Investigational Site | Lancaster | LA1 1RP | United Kingdom |
| GSK Investigational Site | Langport, Somerset | TA10 9RH | United Kingdom |
| GSK Investigational Site | Leicester | LE4 0UZ | United Kingdom |
| GSK Investigational Site | Lichfield | WS13 6JL | United Kingdom |
| GSK Investigational Site | London | NW3 1NR | United Kingdom |
| GSK Investigational Site | London | SE11 6SP | United Kingdom |
| GSK Investigational Site | London | W11 1PA | United Kingdom |
| GSK Investigational Site | Lutterworth, Leicestershire | LE17 4EB | United Kingdom |
| GSK Investigational Site | Mossley, Ashton Under Lyne | OL5 0HE | United Kingdom |
| GSK Investigational Site | Nantwich, Cheshire | CW5 5NX | United Kingdom |
| GSK Investigational Site | Norwich, Norfolk | NR12 8DU | United Kingdom |
| GSK Investigational Site | Norwich, Norfolk | NR3 2HW | United Kingdom |
| GSK Investigational Site | Nottingham | NG7 2QW | United Kingdom |
| GSK Investigational Site | Orton Goldhay, Peterborough | PE2 5GP | United Kingdom |
| GSK Investigational Site | Oxfordshire | OX12 9BN | United Kingdom |
| GSK Investigational Site | Paiginton, Devon | TQ3 3TB | United Kingdom |
| GSK Investigational Site | Radstock, Bath | BA3 2UH | United Kingdom |
| GSK Investigational Site | Romsey, Hampshire | SO517QN | United Kingdom |
| GSK Investigational Site | Rowlands Castle | PO9 6BN | United Kingdom |
| GSK Investigational Site | Ruislip | HA4 6ER | United Kingdom |
| GSK Investigational Site | Runcorn, Cheshire | WA7 1AB | United Kingdom |
| GSK Investigational Site | Salisbury, Hampshire | SP1 1DX | United Kingdom |
| GSK Investigational Site | Sedgefield | TS21 3BN | United Kingdom |
| GSK Investigational Site | Shipston-on-Stour, Warwickshire | CV36 4BQ | United Kingdom |
| GSK Investigational Site | Somerset | TA18 8BX | United Kingdom |
| GSK Investigational Site | Southbourne, Hampshire | PO10 8JH | United Kingdom |
| GSK Investigational Site | Southsea, Hampshire | P05 3ND | United Kingdom |
| GSK Investigational Site | Stowmarket,Suffolk | IP14 1NL | United Kingdom |
| GSK Investigational Site | Sunderland | SR3 4HG | United Kingdom |
| GSK Investigational Site | Sway, Hampshire | S041 6BA | United Kingdom |
| GSK Investigational Site | Swindon, Wiltshire | SN25 1QQ | United Kingdom |
| GSK Investigational Site | Tadworth,Surrey | KT20 5JE | United Kingdom |
| GSK Investigational Site | Tarporley,Cheshire | CW6 0BE | United Kingdom |
| GSK Investigational Site | Thornbury, Bristol | BS35 1DP | United Kingdom |
| GSK Investigational Site | Wandsford, Peterborough | PE8 6PL | United Kingdom |
| GSK Investigational Site | Wantage | OX12 9BN | United Kingdom |
| GSK Investigational Site | Wantage, Oxon | OX12 9BN | United Kingdom |
| GSK Investigational Site | Western Approach,Plymouth | PL1 5AJ | United Kingdom |
| GSK Investigational Site | Westhoughton, Bolton | BL5 3UB | United Kingdom |
| GSK Investigational Site | Wiltshire, Westbury | BA13 3JD | United Kingdom |
| GSK Investigational Site | Wiltshire | SN10 4AQ | United Kingdom |
| GSK Investigational Site | Windemere,Cumbria | LA23 2EG | United Kingdom |
| GSK Investigational Site | Wokingham, Berkshire | RG41 3DR | United Kingdom |
| GSK Investigational Site | York | YO24 4HD | United Kingdom |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided