The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
NicVAX Vaccine given 6 times over 6 months
NicVAX Investigator
Huntsville, Alabama, United States
NicVAX Investigator
San Diego, California, United States
NicVAX Investigator
Melbourne, Florida, United States
NicVAX Investigator
Peoria, Illinois, United States
Immunogenicity
To compare imunogenicity of two lots by serum antibody concentration
Time frame: At Week 14
Safety
Assess safety by adverse events reported
Time frame: Through Week 16
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NicVAX Investigator
South Bend, Indiana, United States
NicVAX Investigator
Rockville, Maryland, United States