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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza

Treatments: Other: Safety follow up

Study type: Observational

Funder types: Industry

Identifiers

NCT00996853

113585

Details and patient eligibility

About

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.

Full description

Collaborator: Medicines and Healthcare products Regulatory Agency

Enrollment: 9,206 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

9,206 participants in 1 patient group

Total vaccinated cohort

Description:

The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.

Treatment:

Other: Safety follow up