Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
GSK Investigational Site
Finsterwalde, Brandenburg, Germany
GSK Investigational Site
Tostedt, Lower Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Freiberg, Saxony, Germany
GSK Investigational Site
Geringswalde, Saxony, Germany
GSK Investigational Site
Schmiedeberg, Saxony, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Geometric mean titers (GMTs) of serum antibodies
Time frame: At Days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
Time frame: At days 21, 42 and 180
Occurrence of solicited local and general adverse events
Time frame: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
Occurrence of unsolicited adverse events
Time frame: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
Occurrence of serious adverse events
Time frame: During the entire study (Days 0 to 180)
To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Geometric mean titers (GMTs) of serum antibodies
Time frame: At Days 0, 21, 42 and 180
To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
Time frame: At days 0, 21, 42 and 180
To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
Time frame: At Days 21, 42 and 180
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.