- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00996853
Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom (H1N1 PASS UK)
Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)
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.
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Addlestone,Surrey, Royaume-Uni, KT15 2BH
- GSK Investigational Site
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Attleborough, Norfolk, Royaume-Uni, NR17 2AS
- GSK Investigational Site
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Axbridge, Somerset, Royaume-Uni, BS26 2BJ
- GSK Investigational Site
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Baldock, Herts, Royaume-Uni, SG7 6BP
- GSK Investigational Site
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Balham, London, Royaume-Uni, SW12 8WU
- GSK Investigational Site
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Bath, Avon, Royaume-Uni, BA2 4JT
- GSK Investigational Site
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Bath, Somerset, Royaume-Uni, BA2 4BY
- GSK Investigational Site
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Bedwell Crescent, Stevenage, Royaume-Uni, SG1 1LQ
- GSK Investigational Site
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Blenheim Walk, Leeds, Royaume-Uni, LS2 9AE
- GSK Investigational Site
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Botesdale, Royaume-Uni, IP22 1DW
- GSK Investigational Site
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Boughton, King's Lynn, Royaume-Uni, PE33 9AG
- GSK Investigational Site
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Bristol, Avon, Royaume-Uni, BS13 8LD
- GSK Investigational Site
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Bromsgrove,Worcestershire, Royaume-Uni, B61 8DT
- GSK Investigational Site
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Chard, Somerset, Royaume-Uni, TA20 1QF
- GSK Investigational Site
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Chesterfield, Royaume-Uni, S41 8NA
- GSK Investigational Site
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Colchester,Essex, Royaume-Uni, CO4 9YN
- GSK Investigational Site
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Comberton,Cambridge, Royaume-Uni, CB23 7DY
- GSK Investigational Site
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Darlington, Co. Durham, Royaume-Uni, DL3 8SQ
- GSK Investigational Site
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Devon, Royaume-Uni, EX9 6LS
- GSK Investigational Site
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Didcot,Oxfordshire, Royaume-Uni, OX11 7JH
- GSK Investigational Site
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Doncaster, Royaume-Uni, DN9 1EP
- GSK Investigational Site
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Ecclesfield, Royaume-Uni, S35 9XQ
- GSK Investigational Site
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Ellesmere Port,Cheshire, Royaume-Uni, CH66 2WW
- GSK Investigational Site
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Escrick, York, Royaume-Uni, YO19 6LE
- GSK Investigational Site
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Essex, Royaume-Uni, CO3 4LN
- GSK Investigational Site
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Fleetwood, Royaume-Uni, FY7 6HD
- GSK Investigational Site
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Gosport, Royaume-Uni, PO12 3AQ
- GSK Investigational Site
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Hanworth, Feltham, Royaume-Uni, TW13 6HD
- GSK Investigational Site
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Harrogate, Royaume-Uni, HG3 5AT
- GSK Investigational Site
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Harwood, Bolton, Royaume-Uni, BL2 3HQ
- GSK Investigational Site
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Hertfordshire, Royaume-Uni, SG6 4TS
- GSK Investigational Site
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High Kelling,Holt,Norfolk, Royaume-Uni, NR25 6QA
- GSK Investigational Site
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Honiton,Devon, Royaume-Uni, EX14 2NY
- GSK Investigational Site
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Hoyland, Barnsley, Royaume-Uni, S74 9AF
- GSK Investigational Site
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Hurstpierpoint, West Sussex, Royaume-Uni, BN6 9UQ
- GSK Investigational Site
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Kent, Sevenoaks, Royaume-Uni, TN13 3NT
- GSK Investigational Site
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Kettering,Kettering, Royaume-Uni, NN14 1SN
- GSK Investigational Site
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Kippax,Leeds, Royaume-Uni, LS25 7JN
- GSK Investigational Site
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Lambeth, London, Royaume-Uni, SW16 5LS
- GSK Investigational Site
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Lancashire, Royaume-Uni, BL1 6AP
- GSK Investigational Site
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Lancaster, Royaume-Uni, LA1 1RP
- GSK Investigational Site
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Langport, Somerset, Royaume-Uni, TA10 9RH
- GSK Investigational Site
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Leicester, Royaume-Uni, LE4 0UZ
- GSK Investigational Site
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Lichfield, Royaume-Uni, WS13 6JL
- GSK Investigational Site
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London, Royaume-Uni, NW3 1NR
- GSK Investigational Site
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London, Royaume-Uni, SE11 6SP
- GSK Investigational Site
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London, Royaume-Uni, W11 1PA
- GSK Investigational Site
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Lutterworth, Leicestershire, Royaume-Uni, LE17 4EB
- GSK Investigational Site
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Mossley, Ashton Under Lyne, Royaume-Uni, OL5 0HE
- GSK Investigational Site
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Nantwich, Cheshire, Royaume-Uni, CW5 5NX
- GSK Investigational Site
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Norwich, Norfolk, Royaume-Uni, NR12 8DU
- GSK Investigational Site
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Norwich, Norfolk, Royaume-Uni, NR3 2HW
- GSK Investigational Site
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Nottingham, Royaume-Uni, NG7 2QW
- GSK Investigational Site
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Orton Goldhay, Peterborough, Royaume-Uni, PE2 5GP
- GSK Investigational Site
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Oxfordshire, Royaume-Uni, OX12 9BN
- GSK Investigational Site
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Paiginton, Devon, Royaume-Uni, TQ3 3TB
- GSK Investigational Site
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Radstock, Bath, Royaume-Uni, BA3 2UH
- GSK Investigational Site
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Romsey, Hampshire, Royaume-Uni, SO517QN
- GSK Investigational Site
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Rowlands Castle, Royaume-Uni, PO9 6BN
- GSK Investigational Site
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Ruislip, Royaume-Uni, HA4 6ER
- GSK Investigational Site
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Runcorn, Cheshire, Royaume-Uni, WA7 1AB
- GSK Investigational Site
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Salisbury, Hampshire, Royaume-Uni, SP1 1DX
- GSK Investigational Site
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Sedgefield, Royaume-Uni, TS21 3BN
- GSK Investigational Site
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Shipston-on-Stour, Warwickshire, Royaume-Uni, CV36 4BQ
- GSK Investigational Site
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Somerset, Royaume-Uni, TA18 8BX
- GSK Investigational Site
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Southbourne, Hampshire, Royaume-Uni, PO10 8JH
- GSK Investigational Site
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Southsea, Hampshire, Royaume-Uni, P05 3ND
- GSK Investigational Site
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Stowmarket,Suffolk, Royaume-Uni, IP14 1NL
- GSK Investigational Site
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Sunderland, Royaume-Uni, SR3 4HG
- GSK Investigational Site
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Sway, Hampshire, Royaume-Uni, S041 6BA
- GSK Investigational Site
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Swindon, Wiltshire, Royaume-Uni, SN25 1QQ
- GSK Investigational Site
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Tadworth,Surrey, Royaume-Uni, KT20 5JE
- GSK Investigational Site
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Tarporley,Cheshire, Royaume-Uni, CW6 0BE
- GSK Investigational Site
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Thornbury, Bristol, Royaume-Uni, BS35 1DP
- GSK Investigational Site
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Wandsford, Peterborough, Royaume-Uni, PE8 6PL
- GSK Investigational Site
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Wantage, Royaume-Uni, OX12 9BN
- GSK Investigational Site
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Wantage, Oxon, Royaume-Uni, OX12 9BN
- GSK Investigational Site
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Western Approach,Plymouth, Royaume-Uni, PL1 5AJ
- GSK Investigational Site
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Westhoughton, Bolton, Royaume-Uni, BL5 3UB
- GSK Investigational Site
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Wiltshire, Royaume-Uni, SN10 4AQ
- GSK Investigational Site
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Wiltshire, Westbury, Royaume-Uni, BA13 3JD
- GSK Investigational Site
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Windemere,Cumbria, Royaume-Uni, LA23 2EG
- GSK Investigational Site
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Wokingham, Berkshire, Royaume-Uni, RG41 3DR
- GSK Investigational Site
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York, Royaume-Uni, YO24 4HD
- GSK Investigational Site
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Cambridgeshire
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Cambridge, Cambridgeshire, Royaume-Uni, CB3 9HS
- GSK Investigational Site
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Hertfordshire
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Watford, Hertfordshire, Royaume-Uni, WD25 0EA
- GSK Investigational Site
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Kent
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Canterbury, Kent, Royaume-Uni, CT1 3HX
- GSK Investigational Site
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Lancashire
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Blackburn, Lancashire, Royaume-Uni, BB2 2ST
- GSK Investigational Site
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Northamptonshire
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Wellingborough, Northamptonshire, Royaume-Uni, NN8 4RW
- GSK Investigational Site
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Somerset
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Bath, Somerset, Royaume-Uni, BA2 1NH
- GSK Investigational Site
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Frome, Somerset, Royaume-Uni, BA11 1EZ
- GSK Investigational Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Total vaccinated cohort
The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Medically-attended adverse events
Délai: Within one month after any dose
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Within one month after any dose
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Adverse events solicited to assess reactogenicity
Délai: Within seven days after any dose
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Within seven days after any dose
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Serious adverse events and adverse events of special interest
Délai: Within six months after the second vaccine dose or within a maximum of eight months after the first dose
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Within six months after the second vaccine dose or within a maximum of eight months after the first dose
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Pregnancy outcomes
Délai: Within two months after vaccination (last menstrual period up to 45 days after any dose)
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Within two months after vaccination (last menstrual period up to 45 days after any dose)
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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. Erratum In: BMJ Open. 2013 Feb 19;3(2):null.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 113585
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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