Last updated: 11/03/2018 15:20:39
Post-Authorization Safety Study of GSK Biologicals’ pandemic influenza vaccine (H1N1) in the United KingdomH1N1 PASS UK
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals’ pandemic influenza vaccine (GSK2340272A) in the United Kingdom (UK)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Medically-attended adverse events
Timeframe: Within one month after any dose
Secondary outcomes:
Adverse events solicited to assess reactogenicity
Timeframe: Within seven days after any dose
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
Pregnancy outcomes
Timeframe: Within two months after vaccination (last menstrual period up to 45 days after any dose)
Interventions:
Other: Safety follow up
Enrollment:
9206
Observational study model:
Cohort
Primary completion date:
2010-20-10
Time perspective:
Prospective
Clinical publications:
Nazareth I et al. (2013) Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a prospective cohort study. BMJ Open. 3(2). pii: e001912. doi: 10.1136/bmjopen-2012-001912.
Tavares F et al. (2011) 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. 29(37):6358-6365.
Nazareth I et al. (2013) Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a prospective cohort study. BMJ Open. 3(2).
Medical condition
Influenza
Product
GSK2340272A, GSK2647158A
Collaborators
Not applicable
Study date(s)
October 2009 to April 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Yes
- 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
- Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
- Child in care
Inclusion and exclusion criteria
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
Written informed consent, and assent where appropriate, obtained from the subject/from the subject’s parent(s)/ Legally Acceptable Representative(s) (LAR).
Exclusion criteria:
- Child in care
Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
Trial location(s)
Location
GSK Investigational Site
Ellesmere Port,Cheshire, United Kingdom, CH66 2WW
Status
Study Complete
Location
GSK Investigational Site
Frome, Somerset, United Kingdom, BA11 1EZ
Status
Study Complete
Location
GSK Investigational Site
Radstock, Bath, United Kingdom, BA3 2UH
Status
Study Complete
Location
GSK Investigational Site
Canterbury, Kent, United Kingdom, CT1 3HX
Status
Study Complete
Location
GSK Investigational Site
Wandsford, Peterborough, United Kingdom, PE8 6PL
Status
Study Complete
Location
GSK Investigational Site
High Kelling,Holt,Norfolk, United Kingdom, NR25 6QA
Status
Study Complete
Location
GSK Investigational Site
Wantage, Oxon, United Kingdom, OX12 9BN
Status
Study Complete
Location
GSK Investigational Site
Watford, Hertfordshire, United Kingdom, WD25 0EA
Status
Study Complete
Location
GSK Investigational Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
Status
Study Complete
Location
GSK Investigational Site
Mossley, Ashton under Lyne, United Kingdom, OL5 0HE
Status
Study Complete
Location
GSK Investigational Site
Lambeth, London, United Kingdom, SW16 5LS
Status
Study Complete
Location
GSK Investigational Site
Hertfordshire, United Kingdom, SG6 4TS
Status
Study Complete
Location
GSK Investigational Site
Hanworth, Feltham, United Kingdom, TW13 6HD
Status
Study Complete
Location
GSK Investigational Site
Hoyland, Barnsley, United Kingdom, S74 9AF
Status
Study Complete
Location
GSK Investigational Site
Southsea, Hampshire, United Kingdom, P05 3ND
Status
Study Complete
Location
GSK Investigational Site
Colchester,Essex, United Kingdom, CO4 9YN
Status
Study Complete
Location
GSK Investigational Site
Southbourne, Hampshire, United Kingdom, PO10 8JH
Status
Study Complete
Location
GSK Investigational Site
Sway, Hampshire, United Kingdom, S041 6BA
Status
Study Complete
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB3 9HS
Status
Study Complete
Location
GSK Investigational Site
Baldock, Herts, United Kingdom, SG7 6BP
Status
Study Complete
Location
GSK Investigational Site
Salisbury, Hampshire, United Kingdom, SP1 1DX
Status
Study Complete
Location
GSK Investigational Site
Paiginton, Devon, United Kingdom, TQ3 3TB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tadworth,Surrey, United Kingdom, KT20 5JE
Status
Study Complete
Location
GSK Investigational Site
Honiton,Devon, United Kingdom, EX14 2NY
Status
Study Complete
Location
GSK Investigational Site
Blackburn, Lancashire, United Kingdom, BB2 2ST
Status
Study Complete
Location
GSK Investigational Site
Langport, Somerset, United Kingdom, TA10 9RH
Status
Study Complete
Location
GSK Investigational Site
Swindon, Wiltshire, United Kingdom, SN25 1QQ
Status
Study Complete
Location
GSK Investigational Site
Westhoughton, Bolton, United Kingdom, BL5 3UB
Status
Study Complete
Location
GSK Investigational Site
Blenheim Walk, Leeds, United Kingdom, LS2 9AE
Status
Study Complete
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA2 1NH
Status
Study Complete
Location
GSK Investigational Site
Kippax,Leeds, United Kingdom, LS25 7JN
Status
Study Complete
Location
GSK Investigational Site
Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
Status
Study Complete
Location
GSK Investigational Site
Rowlands Castle, United Kingdom, PO9 6BN
Status
Study Complete
Location
GSK Investigational Site
Runcorn, Cheshire, United Kingdom, WA7 1AB
Status
Study Complete
Location
GSK Investigational Site
Lutterworth, Leicestershire, United Kingdom, LE17 4EB
Status
Study Complete
Location
GSK Investigational Site
Addlestone,Surrey, United Kingdom, KT15 2BH
Status
Study Complete
Location
GSK Investigational Site
Kettering,Kettering, United Kingdom, NN14 1SN
Status
Study Complete
Location
GSK Investigational Site
Tarporley,Cheshire, United Kingdom, CW6 0BE
Status
Study Complete
Location
GSK Investigational Site
Bromsgrove,Worcestershire, United Kingdom, B61 8DT
Status
Study Complete
Location
GSK Investigational Site
Kent, Sevenoaks, United Kingdom, TN13 3NT
Status
Study Complete
Location
GSK Investigational Site
Comberton,Cambridge, United Kingdom, CB23 7DY
Status
Study Complete
Location
GSK Investigational Site
Norwich, Norfolk, United Kingdom, NR12 8DU
Status
Study Complete
Location
GSK Investigational Site
Nantwich, Cheshire, United Kingdom, CW5 5NX
Status
Study Complete
Location
GSK Investigational Site
Boughton, King’s Lynn, United Kingdom, PE33 9AG
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA2 4BY
Status
Study Complete
Location
GSK Investigational Site
Attleborough, Norfolk, United Kingdom, NR17 2AS
Status
Study Complete
Location
GSK Investigational Site
Romsey, Hampshire, United Kingdom, SO517QN
Status
Study Complete
Location
GSK Investigational Site
Chard, Somerset, United Kingdom, TA20 1QF
Status
Study Complete
Location
GSK Investigational Site
Norwich, Norfolk, United Kingdom, NR3 2HW
Status
Study Complete
Location
GSK Investigational Site
Orton Goldhay, Peterborough, United Kingdom, PE2 5GP
Status
Study Complete
Location
GSK Investigational Site
Western Approach,Plymouth, United Kingdom, PL1 5AJ
Status
Study Complete
Location
GSK Investigational Site
Ecclesfield, United Kingdom, S35 9XQ
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bristol, Avon, United Kingdom, BS13 8LD
Status
Study Complete
Location
GSK Investigational Site
Darlington, Co. Durham, United Kingdom, DL3 8SQ
Status
Study Complete
Location
GSK Investigational Site
Harwood, Bolton, United Kingdom, BL2 3HQ
Status
Study Complete
Location
GSK Investigational Site
Wokingham, Berkshire, United Kingdom, RG41 3DR
Status
Study Complete
Location
GSK Investigational Site
Shipston-on-Stour, Warwickshire, United Kingdom, CV36 4BQ
Status
Study Complete
Location
GSK Investigational Site
Windemere,Cumbria, United Kingdom, LA23 2EG
Status
Study Complete
Location
GSK Investigational Site
Wiltshire, Westbury, United Kingdom, BA13 3JD
Status
Study Complete
Location
GSK Investigational Site
Escrick, York, United Kingdom, YO19 6LE
Status
Study Complete
Location
GSK Investigational Site
Stowmarket,Suffolk, United Kingdom, IP14 1NL
Status
Study Complete
Location
GSK Investigational Site
Bedwell Crescent, Stevenage, United Kingdom, SG1 1LQ
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hurstpierpoint, West Sussex, United Kingdom, BN6 9UQ
Status
Study Complete
Location
GSK Investigational Site
Didcot,Oxfordshire, United Kingdom, OX11 7JH
Status
Study Complete
Location
GSK Investigational Site
Thornbury, Bristol, United Kingdom, BS35 1DP
Status
Study Complete
Location
GSK Investigational Site
Balham, London, United Kingdom, SW12 8WU
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-20-10
Actual study completion date
2011-06-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website