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
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|
|Study Type :||Observational|
|Actual Enrollment :||9206 participants|
|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|
|Actual Primary Completion Date :||October 20, 2010|
|Actual Study Completion Date :||April 6, 2011|
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.
- Medically-attended adverse events [ Time Frame: Within one month after any dose ]
- 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) ]
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
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|