Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom

NCT00996853 | Completed

• 1 other identifier: 113585
• Study Type: observational
• Target: 9,206
• Locations: 1 country
• Sites: 91

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.

Conditions

Influenza

Keywords

safety; Influenza; vaccine; reactogenicity; swine flu

Outcome Measures

Primary Outcomes (1)

• Medically-attended adverse events

  Within one month after any dose

Secondary Outcomes (3)

• 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

• Pregnancy outcomes

  Within two months after vaccination (last menstrual period up to 45 days after any dose)

Study Arms (1)

Total vaccinated cohort

The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.

Other: Safety follow up

Interventions

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.

Total vaccinated cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
• Child in care

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (91)

GSK Investigational Site

Cambridge, Cambridgeshire, CB3 9HS, United Kingdom

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GSK Investigational Site

Watford, Hertfordshire, WD25 0EA, United Kingdom

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Canterbury, Kent, CT1 3HX, United Kingdom

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Blackburn, Lancashire, BB2 2ST, United Kingdom

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Wellingborough, Northamptonshire, NN8 4RW, United Kingdom

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Bath, Somerset, BA2 1NH, United Kingdom

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Frome, Somerset, BA11 1EZ, United Kingdom

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Addlestone,Surrey, KT15 2BH, United Kingdom

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Attleborough, Norfolk, NR17 2AS, United Kingdom

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Axbridge, Somerset, BS26 2BJ, United Kingdom

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Baldock, Herts, SG7 6BP, United Kingdom

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Balham, London, SW12 8WU, United Kingdom

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Bath, Avon, BA2 4JT, United Kingdom

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Bath, Somerset, BA2 4BY, United Kingdom

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Bedwell Crescent, Stevenage, SG1 1LQ, United Kingdom

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Blenheim Walk, Leeds, LS2 9AE, United Kingdom

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Botesdale, IP22 1DW, United Kingdom

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Boughton, King's Lynn, PE33 9AG, United Kingdom

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Bristol, Avon, BS13 8LD, United Kingdom

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Bromsgrove,Worcestershire, B61 8DT, United Kingdom

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Chard, Somerset, TA20 1QF, United Kingdom

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Chesterfield, S41 8NA, United Kingdom

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Colchester,Essex, CO4 9YN, United Kingdom

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Comberton,Cambridge, CB23 7DY, United Kingdom

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Darlington, Co. Durham, DL3 8SQ, United Kingdom

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Devon, EX9 6LS, United Kingdom

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Didcot,Oxfordshire, OX11 7JH, United Kingdom

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Doncaster, DN9 1EP, United Kingdom

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Ecclesfield, S35 9XQ, United Kingdom

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Ellesmere Port,Cheshire, CH66 2WW, United Kingdom

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Escrick, York, YO19 6LE, United Kingdom

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Essex, CO3 4LN, United Kingdom

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Fleetwood, FY7 6HD, United Kingdom

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Gosport, PO12 3AQ, United Kingdom

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Hanworth, Feltham, TW13 6HD, United Kingdom

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Harrogate, HG3 5AT, United Kingdom

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Harwood, Bolton, BL2 3HQ, United Kingdom

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Hertfordshire, SG6 4TS, United Kingdom

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High Kelling,Holt,Norfolk, NR25 6QA, United Kingdom

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Honiton,Devon, EX14 2NY, United Kingdom

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Hoyland, Barnsley, S74 9AF, United Kingdom

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Hurstpierpoint, West Sussex, BN6 9UQ, United Kingdom

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Kent, Sevenoaks, TN13 3NT, United Kingdom

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Kettering,Kettering, NN14 1SN, United Kingdom

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Kippax,Leeds, LS25 7JN, United Kingdom

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Lambeth, London, SW16 5LS, United Kingdom

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Lancashire, BL1 6AP, United Kingdom

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Lancaster, LA1 1RP, United Kingdom

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Langport, Somerset, TA10 9RH, United Kingdom

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Leicester, LE4 0UZ, United Kingdom

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Lichfield, WS13 6JL, United Kingdom

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London, NW3 1NR, United Kingdom

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London, SE11 6SP, United Kingdom

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London, W11 1PA, United Kingdom

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Lutterworth, Leicestershire, LE17 4EB, United Kingdom

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Mossley, Ashton Under Lyne, OL5 0HE, United Kingdom

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Nantwich, Cheshire, CW5 5NX, United Kingdom

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Norwich, Norfolk, NR12 8DU, United Kingdom

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Norwich, Norfolk, NR3 2HW, United Kingdom

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Nottingham, NG7 2QW, United Kingdom

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Orton Goldhay, Peterborough, PE2 5GP, United Kingdom

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Oxfordshire, OX12 9BN, United Kingdom

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Paiginton, Devon, TQ3 3TB, United Kingdom

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Radstock, Bath, BA3 2UH, United Kingdom

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Romsey, Hampshire, SO517QN, United Kingdom

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Rowlands Castle, PO9 6BN, United Kingdom

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Ruislip, HA4 6ER, United Kingdom

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Runcorn, Cheshire, WA7 1AB, United Kingdom

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Salisbury, Hampshire, SP1 1DX, United Kingdom

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Sedgefield, TS21 3BN, United Kingdom

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Shipston-on-Stour, Warwickshire, CV36 4BQ, United Kingdom

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Somerset, TA18 8BX, United Kingdom

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Southbourne, Hampshire, PO10 8JH, United Kingdom

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Southsea, Hampshire, P05 3ND, United Kingdom

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Stowmarket,Suffolk, IP14 1NL, United Kingdom

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Sunderland, SR3 4HG, United Kingdom

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Sway, Hampshire, S041 6BA, United Kingdom

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Swindon, Wiltshire, SN25 1QQ, United Kingdom

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Tadworth,Surrey, KT20 5JE, United Kingdom

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Tarporley,Cheshire, CW6 0BE, United Kingdom

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Thornbury, Bristol, BS35 1DP, United Kingdom

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Wandsford, Peterborough, PE8 6PL, United Kingdom

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Wantage, OX12 9BN, United Kingdom

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Wantage, Oxon, OX12 9BN, United Kingdom

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Western Approach,Plymouth, PL1 5AJ, United Kingdom

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Westhoughton, Bolton, BL5 3UB, United Kingdom

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Wiltshire, Westbury, BA13 3JD, United Kingdom

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Wiltshire, SN10 4AQ, United Kingdom

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Windemere,Cumbria, LA23 2EG, United Kingdom

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Wokingham, Berkshire, RG41 3DR, United Kingdom

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GSK Investigational Site

York, YO24 4HD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23388195 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.

  PMID: 21596080 BACKGROUND

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: October 31, 2009
• Primary Completion: October 20, 2010
• Study Completion: April 6, 2011
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

GB (91)