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

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ClinicalTrials.gov Identifier: NCT00996853
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment
Influenza Other: Safety follow up

Detailed Description:
Collaborator: Medicines and Healthcare products Regulatory Agency

Study Type : Observational
Actual Enrollment : 9206 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorization Safety Study (PASS) of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK2340272A) in the United Kingdom (UK)
Actual Study Start Date : October 31, 2009
Primary Completion Date : October 20, 2010
Study Completion Date : April 6, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Group/Cohort Intervention/treatment
Total vaccinated cohort
The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.
Other: Safety follow up
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.



Primary Outcome Measures :
  1. Medically-attended adverse events [ Time Frame: Within one month after any dose ]

Secondary Outcome Measures :
  1. Adverse events solicited to assess reactogenicity [ Time Frame: Within seven days after any dose ]
  2. 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 ]
  3. Pregnancy outcomes [ Time Frame: Within two months after vaccination (last menstrual period up to 45 days after any dose) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996853


  Show 91 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00996853     History of Changes
Other Study ID Numbers: 113585
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Keywords provided by GlaxoSmithKline:
safety
Influenza
vaccine
reactogenicity
swine flu

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs