Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom (H1N1 PASS UK)
|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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996853
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|