Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
Completed
- Conditions
- Influenza
- Interventions
- Other: Safety follow up
- Registration Number
- NCT00996853
- Lead Sponsor
- 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.
- Detailed Description
Collaborator: Medicines and Healthcare products Regulatory Agency
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9206
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Total vaccinated cohort Safety follow up The Total vaccinated cohort will include all subjects with at least one vaccine administration documented.
- Primary Outcome Measures
Name Time Method Medically-attended adverse events Within one month after any dose
- Secondary Outcome Measures
Name Time Method Adverse events solicited to assess reactogenicity Within seven days after any dose Serious adverse events and adverse events of special interest Within six months after the second vaccine dose or within a maximum of eight months after the first dose Pregnancy outcomes Within two months after vaccination (last menstrual period up to 45 days after any dose)
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧York, United Kingdom