Immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,270
surface antigen, inactivated, prepared in cell cultures
Placebo
Site Reference ID/Investigator# 45690
Jacksonville, Florida, United States
Site Reference ID/Investigator# 45687
Pembroke Pines, Florida, United States
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
Time frame: 3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
Time frame: 6 months
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Time frame: 6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
Time frame: 3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
Time frame: 6 months
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Site Reference ID/Investigator# 45697
South Miami, Florida, United States
Site Reference ID/Investigator# 45691
Lenexa, Kansas, United States
Site Reference ID/Investigator# 45689
Overland Park, Kansas, United States
Site Reference ID/Investigator# 45694
Wichita, Kansas, United States
Site Reference ID/Investigator# 45682
Lexington, Kentucky, United States
Site Reference ID/Investigator# 45684
Kansas City, Missouri, United States
Site Reference ID/Investigator# 45685
Omaha, Nebraska, United States
Site Reference ID/Investigator# 45686
Las Vegas, Nevada, United States
...and 5 more locations