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
Study complete
Study complete
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:
Enrollment:
9206
Primary completion date:
2010-20-10
Observational study model:
Cohort
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
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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
Study complete
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
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Access to clinical trial data by researchers
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