The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control. This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7
One dose intramuscular injection
One dose intramuscular injection
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years
Time frame: 21 days after vaccination
Solicited Local and General Symptoms
Time frame: During 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: During 31 days (Day 0 - Day 30) after vaccination
Number of Subjects Reporting Serious Adverse Events
Time frame: During the whole study period (Day 0 - Day 182)
Potential Immune Mediated Diseases
Time frame: During the whole study period (Day 0 - Day 182)
Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years
Time frame: At Days 0, 7 and 182
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GSK Investigational Site
Leipzig, Saxony, Germany