The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
157
2 doses, intramuscular injection
2 doses, intramuscular injection
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Bischofswerda, Saxony, Germany
GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
Time frame: On Day 21 (+- 2) after the second vaccination
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Time frame: Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Time frame: Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Time frame: Throughout the study
GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.
Time frame: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
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GSK Investigational Site
Coswig, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, Germany
...and 3 more locations