The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,452
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Unnamed facility
Huntsville, Alabama, United States
Percentage of Subjects Who Have a Seroprotective Immune Response
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
Time frame: at Week 12 and at Week 32
Percentage of Participants With Local and Systemic Reaction to Injections
Time frame: within 7 days for post-injection reactions
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
San Diego, California, United States
Unnamed facility
Santa Ana, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Melbourne, Florida, United States
Unnamed facility
Pinellas Park, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Peoria, Illinois, United States
Unnamed facility
South Bend, Indiana, United States
...and 22 more locations