InfluenzaH1N1 PASS UKNCT00996853
Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
An observational study of Influenza, run by GlaxoSmithKline at 91 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Safety follow up
- Type of treatment
- Vaccines
- How many people
- 9,206 participants
- Where
- 91 sitesUnited Kingdom
- Study dates
- 31 Oct 2009to 6 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
- Child in care
Trial locations and contacts
91 sites in 1 country.
91 sites in 1 country
United Kingdom91 sites
GSK Investigational Site
Addlestone,Surrey, KT15 2BH
GSK Investigational Site
Attleborough, Norfolk, NR17 2AS
GSK Investigational Site
Axbridge, Somerset, BS26 2BJ
GSK Investigational Site
Baldock, Herts, SG7 6BP
GSK Investigational Site
Balham, London, SW12 8WU
GSK Investigational Site
Bath, Somerset, BA2 1NH
GSK Investigational Site
Bath, Avon, BA2 4JT
GSK Investigational Site
Bath, Somerset, BA2 4BY
GSK Investigational Site
Bedwell Crescent, Stevenage, SG1 1LQ
GSK Investigational Site
Blackburn, Lancashire, BB2 2ST
GSK Investigational Site
Blenheim Walk, Leeds, LS2 9AE
GSK Investigational Site
Botesdale, IP22 1DW
GSK Investigational Site
Boughton, King's Lynn, PE33 9AG
GSK Investigational Site
Bristol, Avon, BS13 8LD
GSK Investigational Site
Bromsgrove,Worcestershire, B61 8DT
GSK Investigational Site
Cambridge, Cambridgeshire, CB3 9HS
GSK Investigational Site
Canterbury, Kent, CT1 3HX
GSK Investigational Site
Chard, Somerset, TA20 1QF
GSK Investigational Site
Chesterfield, S41 8NA
GSK Investigational Site
Colchester,Essex, CO4 9YN
GSK Investigational Site
Comberton,Cambridge, CB23 7DY
GSK Investigational Site
Darlington, Co. Durham, DL3 8SQ
GSK Investigational Site
Devon, EX9 6LS
GSK Investigational Site
Didcot,Oxfordshire, OX11 7JH
GSK Investigational Site
Doncaster, DN9 1EP
GSK Investigational Site
Ecclesfield, S35 9XQ
GSK Investigational Site
Ellesmere Port,Cheshire, CH66 2WW
GSK Investigational Site
Escrick, York, YO19 6LE
GSK Investigational Site
Essex, CO3 4LN
GSK Investigational Site
Fleetwood, FY7 6HD
GSK Investigational Site
Frome, Somerset, BA11 1EZ
GSK Investigational Site
Gosport, PO12 3AQ
GSK Investigational Site
Hanworth, Feltham, TW13 6HD
GSK Investigational Site
Harrogate, HG3 5AT
GSK Investigational Site
Harwood, Bolton, BL2 3HQ
GSK Investigational Site
Hertfordshire, SG6 4TS
GSK Investigational Site
High Kelling,Holt,Norfolk, NR25 6QA
GSK Investigational Site
Honiton,Devon, EX14 2NY
GSK Investigational Site
Hoyland, Barnsley, S74 9AF
GSK Investigational Site
Hurstpierpoint, West Sussex, BN6 9UQ
GSK Investigational Site
Kent, Sevenoaks, TN13 3NT
GSK Investigational Site
Kettering,Kettering, NN14 1SN
GSK Investigational Site
Kippax,Leeds, LS25 7JN
GSK Investigational Site
Lambeth, London, SW16 5LS
GSK Investigational Site
Lancashire, BL1 6AP
GSK Investigational Site
Lancaster, LA1 1RP
GSK Investigational Site
Langport, Somerset, TA10 9RH
GSK Investigational Site
Leicester, LE4 0UZ
GSK Investigational Site
Lichfield, WS13 6JL
GSK Investigational Site
London, NW3 1NR
GSK Investigational Site
London, SE11 6SP
GSK Investigational Site
London, W11 1PA
GSK Investigational Site
Lutterworth, Leicestershire, LE17 4EB
GSK Investigational Site
Mossley, Ashton Under Lyne, OL5 0HE
GSK Investigational Site
Nantwich, Cheshire, CW5 5NX
GSK Investigational Site
Norwich, Norfolk, NR12 8DU
GSK Investigational Site
Norwich, Norfolk, NR3 2HW
GSK Investigational Site
Nottingham, NG7 2QW
GSK Investigational Site
Orton Goldhay, Peterborough, PE2 5GP
GSK Investigational Site
Oxfordshire, OX12 9BN
GSK Investigational Site
Paiginton, Devon, TQ3 3TB
GSK Investigational Site
Radstock, Bath, BA3 2UH
GSK Investigational Site
Romsey, Hampshire, SO517QN
GSK Investigational Site
Rowlands Castle, PO9 6BN
GSK Investigational Site
Ruislip, HA4 6ER
GSK Investigational Site
Runcorn, Cheshire, WA7 1AB
GSK Investigational Site
Salisbury, Hampshire, SP1 1DX
GSK Investigational Site
Sedgefield, TS21 3BN
GSK Investigational Site
Shipston-on-Stour, Warwickshire, CV36 4BQ
GSK Investigational Site
Somerset, TA18 8BX
GSK Investigational Site
Southbourne, Hampshire, PO10 8JH
GSK Investigational Site
Southsea, Hampshire, P05 3ND
GSK Investigational Site
Stowmarket,Suffolk, IP14 1NL
GSK Investigational Site
Sunderland, SR3 4HG
GSK Investigational Site
Sway, Hampshire, S041 6BA
GSK Investigational Site
Swindon, Wiltshire, SN25 1QQ
GSK Investigational Site
Tadworth,Surrey, KT20 5JE
GSK Investigational Site
Tarporley,Cheshire, CW6 0BE
GSK Investigational Site
Thornbury, Bristol, BS35 1DP
GSK Investigational Site
Wandsford, Peterborough, PE8 6PL
GSK Investigational Site
Wantage, OX12 9BN
GSK Investigational Site
Wantage, Oxon, OX12 9BN
GSK Investigational Site
Watford, Hertfordshire, WD25 0EA
GSK Investigational Site
Wellingborough, Northamptonshire, NN8 4RW
GSK Investigational Site
Western Approach,Plymouth, PL1 5AJ
GSK Investigational Site
Westhoughton, Bolton, BL5 3UB
GSK Investigational Site
Wiltshire, SN10 4AQ
GSK Investigational Site
Wiltshire, Westbury, BA13 3JD
GSK Investigational Site
Windemere,Cumbria, LA23 2EG
GSK Investigational Site
Wokingham, Berkshire, RG41 3DR
GSK Investigational Site
York, YO24 4HD
About this study
Official title: 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.
Read the detailed description
Collaborator: Medicines and Healthcare products Regulatory Agency
- Conditions
- Influenza
- Being tested
- Safety follow up
- Keywords
- safety, Influenza, vaccine, reactogenicity, swine flu
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety follow upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Total vaccinated cohort | The Total vaccinated cohort will include all subjects with at least one vaccine administration documented. Receives: Other: Safety follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medically-attended adverse events
Measured: Within one month after any dose
Secondary outcomes (3)
Adverse events solicited to assess reactogenicity
Measured: Within seven days after any dose
Serious adverse events and adverse events of special interest
Measured: Within six months after the second vaccine dose or within a maximum of eight months after the first dose
Pregnancy outcomes
Measured: Within two months after vaccination (last menstrual period up to 45 days after any dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study start31 Oct 2009
- Primary completion20 Oct 2010
- Study completion6 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996853
- Sponsor's protocol ID
- 113585
- Acronym
- H1N1 PASS UK
- Status last verified
- Jan 2018
- First submitted
- 15 Oct 2009
- Last updated
- 16 Jan 2018
- Results posted
- No
Publications
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.
PubMed 23388195Tavares 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.
PubMed 21596080
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)
- ClinicalTrials.gov ID
- NCT00996853
- Acronym / sponsor ID
- H1N1 PASS UK / 113585
- Conditions
- Influenza
- Keywords
- safety, Influenza, vaccine, reactogenicity, swine flu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,206 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2009 (actual)
- Primary completion
- 20 Oct 2010 (actual)
- Study completion
- 6 Apr 2011 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total vaccinated cohort | – | Other: Safety follow upThe Total vaccinated cohort will include all subjects with at least one vaccine administration documented. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
- Child in care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety follow upCollection 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. | Other | Total vaccinated cohort |
Primary outcome
Medically-attended adverse events
Time frame: Within one month after any dose
3 secondary outcomes
Adverse events solicited to assess reactogenicity
Time frame: Within seven days after any dose
Serious adverse events and adverse events of special interest
Time frame: Within six months after the second vaccine dose or within a maximum of eight months after the first dose
Pregnancy outcomes
Time frame: Within two months after vaccination (last menstrual period up to 45 days after any dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Background: PubMed 23388195Nazareth 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.
- Background: PubMed 21596080Tavares 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
91 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by GlaxoSmithKline at 91 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medically-attended adverse events (time frame: Within one month after any dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.