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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996853
First Posted: October 16, 2009
Last Update Posted: June 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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 Intervention
H1N1 Influenza Vaccination Other: Safety follow up

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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) ]

Enrollment: 9206
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:
Collaborator: Medicines and Healthcare products Regulatory Agency
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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


Locations
United Kingdom
GSK Investigational Site
Didcot,Oxfordshire, United Kingdom, OX11 7JH
GSK Investigational Site
Gosport, United Kingdom, PO12 3AQ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00996853     History of Changes
Other Study ID Numbers: 113585
First Submitted: October 15, 2009
First Posted: October 16, 2009
Last Update Posted: June 18, 2012
Last Verified: March 2012

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


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