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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00996853
First received: October 15, 2009
Last updated: June 14, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events solicited to assess reactogenicity [ Time Frame: Within seven days after any dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pregnancy outcomes [ Time Frame: Within two months after vaccination (last menstrual period up to 45 days after any dose) ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00996853     History of Changes
Other Study ID Numbers: 113585
Study First Received: October 15, 2009
Last Updated: June 14, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 16, 2014