This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
521
Intramuscular injection, two doses
Intramuscular injection, two doses
Intramuscular injection, two doses
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Austin, Texas, United States
Immunogenicity with respect to components of the investigational vaccine Day 0
Time frame: Day 0
Immunogenicity with respect to components of the investigational vaccine Day 42
Time frame: Day 42
Occurrence of Grade 3 injection site pain
Time frame: During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of each solicited local symptom
Time frame: During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of each solicited general symptom
Time frame: During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of unsolicited adverse events (AEs)
Time frame: Within 21 days (Day 0 to 20) after any vaccination
Occurrence of AEs with medically attended visits (MAEs)
Time frame: During the entire study period (from Day 0 to Month 12)
Occurrence and relationship to vaccination of (potential) immune mediated diseases (pIMDs)
Time frame: During the entire study period (from Day 0 to Month 12)
Occurrence and relationship to vaccination of serious adverse events (SAEs)
Time frame: During the entire study period (from Screening to Month 12)
Occurrence of adverse pregnancy outcomes
Time frame: During the entire study period (from Day 0 to Month 12)
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Intramuscular injection, two doses
Intramuscular injection, two doses
Clinical safety laboratory abnormalities
Time frame: At Days 7, 28 and at Month 6.
Immunogenicity with respect to components of the investigational vaccine in terms of hemagglutinin Inhibition (HI) antibodies
Time frame: At Days 0, 21, and 42 and Months 6 and 12
Immunogenicity with respect to components of the investigational vaccine in terms of microneutralization (MN) antibodies
Time frame: Days 0, 21, and 42 and Months 6 and 12