Acute hepatitis B without delta-agent and without hepatic coma MedDRA version: 7.1 Level: LLT Classification code 10019731
Conditions
Interventions
Product Name: Hepatitis B Vaccine (Recombinant) Upgraded Process
Product Code: HBV-UP
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Othe
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Twenty to 35 years of age. 2. In general good health based on a medical history taken on Day 1 prior to receiving the first injection of vaccine. Any underlying chronic illness must be documented to be in stable condition. 3. For women, a negative urine pregnancy test just prior to vaccination on Day 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of previous hepatitis B infection. 2. History of vaccination with any hepatitis B vaccine. 3. Recent (less than 72 hours) history of febrile illness (oral temperature =37.7ºC/100.0ºF). 4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB vaccine (e.g., aluminum, yeast). 5. Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product. 6. Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine. 7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine. 8. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. 9. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. 10. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: Among healthy adults who receive the vaccine at 0, 1, and 6 months, to demonstrate that: (1) three lots of process upgrade hepatitis B vaccine (process upgrade vaccine) induce similar responses in antibody to hepatitis B surface antigen (anti-HBs), as measured by seroprotection rate (SPR) one month after the third dose, (2) one month after the third dose, the combined process upgrade lots will exhibit an adequate seroprotection rate, and (3) one month after the third dose, the anti-HBs geometric mean titer (GMT) for the process upgrade vaccine is improved, or at least non-inferior, when compared to the current process hepatitis B vaccine (current process vaccine). ;Secondary Objective: Secondary objective: To assess the safety and tolerability of the process upgrade vaccine in healthy adults. ;Primary end point(s): Primary Hypotheses: 1) The three lots of process upgrade vaccine will, when administered to healthy young adults on a 0, 1, and 6 month schedule, induce similar seroprotection rates to hepatitis B one month post-vaccination. (The primary endpoint for the demonstration of consistency will be the seroprotection rate (an anti-HBs titer = 10 mIU/mL) at 7 months, one month after the third dose of vaccine. The criterion for consistency of the three lots of process upgrade vaccine is that the anti-HBs seroprotection rate will not differ statistically by more than 10 percentage points between any pair of lots.) 2) The three pooled process upgrade vaccine lots will, when administered to healthy young adults on a 0, 1, and 6 month schedule, induce an adequate immune response to hepatitis B one month post vaccination. (The criterion for an adequate response requires ruling out 90.0% by the lower bound of a one-sided 97.5% confidence interval for the anti-HBs seroprotection rate one month after the third dose for the pooled process upgrade lots.) 3A) The process upgrade vaccine, when administered to healthy young adu | — |
Countries
Finland, Sweden
Outcome results
None listed