Clinical trial NCT00996853: Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
Official title: Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: safety
Influenza
vaccine
reactogenicity
swine flu
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 9206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Medically-attended adverse events
timeFrame: Within one month after any dose
Secondary outcomes:
measure: Adverse events solicited to assess reactogenicity
timeFrame: Within seven days after any dose
measure: Serious adverse events and adverse events of special interest
timeFrame: Within six months after the second vaccine dose or within a maximum of eight months after the first dose
measure: Pregnancy outcomes
timeFrame: Within two months after vaccination (last menstrual period up to 45 days after any dose)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Watford
country: United Kingdom
facility: GSK Investigational Site
state: Hertfordshire
city: Canterbury
country: United Kingdom
facility: GSK Investigational Site
state: Kent
city: Blackburn
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Wellingborough
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
city: Bath
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Frome
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Addlestone,Surrey
country: United Kingdom
facility: GSK Investigational Site
city: Attleborough, Norfolk
country: United Kingdom
facility: GSK Investigational Site
city: Axbridge, Somerset
country: United Kingdom
facility: GSK Investigational Site
city: Baldock, Herts
country: United Kingdom
facility: GSK Investigational Site
city: Balham, London
country: United Kingdom
facility: GSK Investigational Site
city: Bath, Avon
country: United Kingdom
facility: GSK Investigational Site
city: Bath, Somerset
country: United Kingdom
facility: GSK Investigational Site
city: Bedwell Crescent, Stevenage
country: United Kingdom
facility: GSK Investigational Site
city: Blenheim Walk, Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Botesdale
country: United Kingdom
facility: GSK Investigational Site
city: Boughton, King's Lynn
country: United Kingdom
facility: GSK Investigational Site
city: Bristol, Avon
country: United Kingdom
facility: GSK Investigational Site
city: Bromsgrove,Worcestershire
country: United Kingdom
facility: GSK Investigational Site
city: Chard, Somerset
country: United Kingdom
facility: GSK Investigational Site
city: Chesterfield
country: United Kingdom
facility: GSK Investigational Site
city: Colchester,Essex
country: United Kingdom
facility: GSK Investigational Site
city: Comberton,Cambridge
country: United Kingdom
facility: GSK Investigational Site
city: Darlington, Co. Durham
country: United Kingdom
facility: GSK Investigational Site
city: Devon
country: United Kingdom
facility: GSK Investigational Site
city: Didcot,Oxfordshire
country: United Kingdom
facility: GSK Investigational Site
city: Doncaster
country: United Kingdom
facility: GSK Investigational Site
city: Ecclesfield
country: United Kingdom
facility: GSK Investigational Site
city: Ellesmere Port,Cheshire
country: United Kingdom
facility: GSK Investigational Site
city: Escrick, York
country: United Kingdom
facility: GSK Investigational Site
city: Essex
country: United Kingdom
facility: GSK Investigational Site
city: Fleetwood
country: United Kingdom
facility: GSK Investigational Site
city: Gosport
country: United Kingdom
facility: GSK Investigational Site
city: Hanworth, Feltham
country: United Kingdom
facility: GSK Investigational Site
city: Harrogate
country: United Kingdom
facility: GSK Investigational Site
city: Harwood, Bolton
country: United Kingdom
facility: GSK Investigational Site
city: Hertfordshire
country: United Kingdom
facility: GSK Investigational Site
city: High Kelling,Holt,Norfolk
country: United Kingdom
facility: GSK Investigational Site
city: Honiton,Devon
country: United Kingdom
facility: GSK Investigational Site
city: Hoyland, Barnsley
country: United Kingdom
facility: GSK Investigational Site
city: Hurstpierpoint, West Sussex
country: United Kingdom
facility: GSK Investigational Site
city: Kent, Sevenoaks
country: United Kingdom
facility: GSK Investigational Site
city: Kettering,Kettering
country: United Kingdom
facility: GSK Investigational Site
city: Kippax,Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Lambeth, London
country: United Kingdom
facility: GSK Investigational Site
city: Lancashire
country: United Kingdom
facility: GSK Investigational Site
city: Lancaster
country: United Kingdom
facility: GSK Investigational Site
city: Langport, Somerset
country: United Kingdom
facility: GSK Investigational Site
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
city: Lichfield
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Lutterworth, Leicestershire
country: United Kingdom
facility: GSK Investigational Site
city: Mossley, Ashton Under Lyne
country: United Kingdom
facility: GSK Investigational Site
city: Nantwich, Cheshire
country: United Kingdom
facility: GSK Investigational Site
city: Norwich, Norfolk
country: United Kingdom
facility: GSK Investigational Site
city: Norwich, Norfolk
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
city: Orton Goldhay, Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: Oxfordshire
country: United Kingdom
facility: GSK Investigational Site
city: Paiginton, Devon
country: United Kingdom
facility: GSK Investigational Site
city: Radstock, Bath
country: United Kingdom
facility: GSK Investigational Site
city: Romsey, Hampshire
country: United Kingdom
facility: GSK Investigational Site
city: Rowlands Castle
country: United Kingdom
facility: GSK Investigational Site
city: Ruislip
country: United Kingdom
facility: GSK Investigational Site
city: Runcorn, Cheshire
country: United Kingdom
facility: GSK Investigational Site
city: Salisbury, Hampshire
country: United Kingdom
facility: GSK Investigational Site
city: Sedgefield
country: United Kingdom
facility: GSK Investigational Site
city: Shipston-on-Stour, Warwickshire
country: United Kingdom
facility: GSK Investigational Site
city: Somerset
country: United Kingdom
facility: GSK Investigational Site
city: Southbourne, Hampshire
country: United Kingdom
facility: GSK Investigational Site
city: Southsea, Hampshire
country: United Kingdom
facility: GSK Investigational Site
city: Stowmarket,Suffolk
country: United Kingdom
facility: GSK Investigational Site
city: Sunderland
country: United Kingdom
facility: GSK Investigational Site
city: Sway, Hampshire
country: United Kingdom
facility: GSK Investigational Site
city: Swindon, Wiltshire
country: United Kingdom
facility: GSK Investigational Site
city: Tadworth,Surrey
country: United Kingdom
facility: GSK Investigational Site
city: Tarporley,Cheshire
country: United Kingdom
facility: GSK Investigational Site
city: Thornbury, Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Wandsford, Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: Wantage, Oxon
country: United Kingdom
facility: GSK Investigational Site
city: Wantage
country: United Kingdom
facility: GSK Investigational Site
city: Western Approach,Plymouth
country: United Kingdom
facility: GSK Investigational Site
city: Westhoughton, Bolton
country: United Kingdom
facility: GSK Investigational Site
city: Wiltshire, Westbury
country: United Kingdom
facility: GSK Investigational Site
city: Wiltshire
country: United Kingdom
facility: GSK Investigational Site
city: Windemere,Cumbria
country: United Kingdom
facility: GSK Investigational Site
city: Wokingham, Berkshire
country: United Kingdom
facility: GSK Investigational Site
city: York
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
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.