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A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.
Age
20 - 35 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
June 1, 2005
Primary Completion Date
May 1, 2006
Completion Date
May 1, 2006
Last Updated
March 16, 2017
860
ACTUAL participants
V232 Modified Process Hepatitis B Vaccine: Lot A
BIOLOGICAL
V232 Modified Process Hepatitis B Vaccine: Lot B
BIOLOGICAL
V232 Modified Process Hepatitis B Vaccine: Lot C
BIOLOGICAL
V232 Current Process Hepatitis B Vaccine
BIOLOGICAL
Lead Sponsor
Merck Sharp & Dohme LLC
Data Source & Attribution
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