Healthy subjects, active immunisation against Hepatitis B MedDRA version: 12.1 Level: LLT Classification code 10019731 Term: Hepatitis B
Conditions
Interventions
Trade Name: HBVaxPRO
Product Name: HBVaxPRO
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: refer to SPC
CAS Number: 0
Other descriptive name: HEPATITIS B VACCINE
Concentration uni
Sponsors
Sanofi Pasteur MSD S.N.C
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In general good health based on a medical history taken on Day 1 prior to receiving the study vaccine injection. 2. Received 3 doses of either modified process RECOMBIVAX HB™ or ENGERIX-BTM as per protocol for study V232-059 at least 2 years prior to enrollment in this study. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known history of previous hepatitis B infection. 2. History of vaccination with any hepatitis B vaccine beyond what was administered in study V232-059. 3. History of febrile illness (oral temperature =37.8ºC or =100.0ºF) within 72 hours prior to study vaccine injection. 4. Known or suspected hypersensitivity to any component of modified process RECOMBIVAX HB™ (e.g., aluminum, yeast). 5. Receipt of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product within 3 months prior to study vaccine injection and until Visit 2 6. Receipt of any licensed inactivated or recombinant vaccine within 14 days prior to study vaccine injection and until Visit 2 7. Receipt of any licensed live-virus vaccine within 30 days prior to study vaccine injection and until Visit 2. 8. Receipt of any investigational drug or other investigational vaccine within 3 months prior to study vaccine injection and until Visit 2. 9. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids or chemotherapeutic agents). Subjects on systemic corticosteroids should be excluded if they received within 4 weeks prior to study entry, are receiving, or are expected to receive prior to Visit 2 systemic corticosteroid doses >5 mg prednisone (or equivalent) daily for >2 weeks. The exclusion does not apply to topical and inhaled steroids. 10. Known or suspected immune dysfunction that is caused by a medical condition, or other cause. Examples of such conditions include: congenital immune deficiency, human immunodeficiency virus infection, transplantations, leukemia, lymphoma, Hodgkin’s’ disease, multiple myeloma/MGUS, or generalize malignancy. Subjects with a history of cancer who have been cancer free since their participation in the original V232-059 study will be eligible for enrollment. 11. Pregnant women and nursing mothers. A urine pregnancy test will be administered to women of childbearing potential prior to vaccination. For the purposes of this protocol, women of non-childbearing potential are defined as having no menses for one year, post-hysterectomy, post-bilateral tubal ligation, or post-bilateral oophorectomy. 12. Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the Seroprotection rate (SPR) at least 2 years following completion of a primary series of modified process RECOMBIVAX HB™ ( HBVaxPRO) and 1 month following a challenge dose of modified process RECOMBIVAX HB™ To describe the Seroprotection rate (SPR) at least 2 years following completion of a primary series of ENGERIX-B™ and 1 month following a challenge dose of modified process RECOMBIVAX HB™.;Secondary Objective: To describe the Geometric Mean Titer (GMT) at least 2 years following completion of a primary series of modified process RECOMBIVAX HB™ and 1 month following a challenge dose of modified process RECOMBIVAX HB™. To describe the Geometric Mean Titer (GMT) at least 2 years following completion of a primary series of ENGERIX-B™ and 1 month following a challenge dose of modified process RECOMBIVAX HB™. ;Primary end point(s): The primary purpose of this study is to estimate the SPR pre-challenge (i.e., 2 year persistence) and again at 1 month after vaccination. Within groups two-sided 95% CI will be provided for SPR calculated on immunogenicity criteria based on the method of Collett. Data with respect to the percentage of subjects with any detectable anti-HBs titer and an anti-HBs titer =100 mIU/mL as well as the GMT will be descriptively summarized for each group. Confidence intervals for the percentage of subjects greater than each cut-off will be calculated as above. The confidence interval for the GMTs will be based on the natural log-transformed titers and the t-distribution. Data will be summarized pre-challenge using the same methodology. Two-hundred and ninety-six (296) subjects completed V232-059 on a per protocol basis. Of these 152 received modified process RECOMBIVAX HB™ and 144 received ENGERIX-B™. Of the 296 subjects, it is estimated that at least 50% will re-enroll and complete this extension study after at least 2 years of time has lapsed following the initial receipt of the primary vaccination series. Therefor | — |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed