Hepatitis B ICD10 classification code : Hepatitis Viral- Type B (ICD10- B16) MedDRA classification code : Infections and Infestations – Viral Hepatitis B MedDRA version: 7.1 Level: LLT Classification code 10019731
Conditions
Interventions
Product Name: Hepatitis B (Recombinant) Vaccine (Glutathione Treated, 0.7 P/Al)
Product Code: NA
Pharmaceutical Form: Suspension for injection
Product Name: Hepatitis B Vaccine (Recombinant) 2X Phsph
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage 1: a. Twenty to 35 years of age. b. 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. c. For women, a negative urine pregnancy test just prior to vaccination on Day 1. d. Women of childbearing potential must demonstrate a method of effective contraception. Effective contraception includes the birth control pill or abstinence during the entire study period. Stage 2: a. Healthy infants. b. Two to 4 months old. c. Available for the study period. Are the trial subjects under 18? yes 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Medical History of previous hepatitis B infection. This includes the mothers of subjects in Stage 2. b. Medical History of vaccination with any other hepatitis B vaccine. This includes the mothers of subjects in Stage 2. c. Medical History of injection drug use. d. Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF; rectal temperature =38.1ºC/=100.5ºF ). e. Known or suspected hypersensitivity to any component of RECOMBIVAX HB vaccine (e.g., aluminum, yeast). f. Recent administration (within 3 months prior to first injection with the study vaccine) of any of the following or if any of the following are scheduled to be given during the study: hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product (excluding autologous products). g. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or if scheduled to be given during the study. h. Known or suspected impairment of immunologic function or recent use (defined as 3 months prior to study start) of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. i. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. j. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. k. Inability to comply with the study schedule and attend all required study visits as outlined in the Study Flow Chart.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (The study is designed in 2 stages) Stage 1: To assess the safety and tolerability of GSH/2X phosphate hepatitis B vaccine in healthy adults. Stage 2 (contingent upon meeting safety requirements of Stage 1): To evaluate the immunogenicity of the GSH/2X phosphate hepatitis B vaccine compared with the 2X phosphate hepatitis B vaccine in healthy infants who receive the vaccine on a 0-, 1-, and 6-month schedule. ;Secondary Objective: Stage 1: To descriptively summarize the immunogenicity of the GSH/2X phosphate hepatitis B vaccine compared with the 2X phosphate hepatitis B vaccine in healthy adults who receive the vaccine on a 0-, 1-, and 6-month schedule. Stage 2: To assess the safety and tolerability of GSH/2X phosphate hepatitis B vaccine in healthy infants. ;Primary end point(s): The key immunogenicity measurement will be the anti-HBs geometric mean titer at Month 7 (one month after the third dose of vaccine). | — |
Countries
Finland
Outcome results
None listed