Hepatitis B MedDRA version: 7.1 Level: LLT Classification code 10019731
Conditions
Interventions
Trade Name: NA
Product Name: Hepatitis B Vaccine (Recombinant) Modified Process
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
Sponsors
MSD (Norge) AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female infants ~2 months of age (40 to 80 days). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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. Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or another known carrier of hepatitis B virus ever living in close contact with the subject. 2. Birth mother, during the course of this pregnancy, did not receive any prenatal care. 3. Previous history of hepatitis B infection. 4. Known or suspected impairment of immunologic function or prior use (defined as 14 days prior to study start) of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. 5. Prior vaccination with any hepatitis B vaccine for infant or mother (within 6 months prior to birth of child). 6. Recent (<72 hours) history of febrile illness ³99.5°F (³37.5°C) axillary or ³100.5°F (³38.1°C), rectal temperature. 7. Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product in the subject, or receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the child. 8. Any prior receipt of investigational drugs or other investigational vaccines by the infant since birth or by the mother if breastfeeding within 14 days prior to first injection with the study vaccine or if scheduled to be given to the infant during the study. 9. Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast). 10. Any infant who cannot be adequately followed for study visits during the course of the clinical study. 11. Any condition that in the opinion of the investigator may interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that at 1 month after the third dose of vaccine, either the modified process hepatitis B vaccine at 5 µg/0.5 mL or RECOMBIVAX HB™ will induce adequate seroprotection rates (SPR). ; Secondary Objective: 1. To demonstrate that at 1 month after the third dose pf vaccine either the modified process Hepatitis B vaccine at 5 µ/0.5 mL or Recombivax HB™ will induce similar geometric mean titers (GMT). 2. To determine whether, 1 month after the third dose of vaccine, the anti-HBs GMT for the modified process hepatitis B vaccine administered at a dose of 10 µg/0.5 mL is similar to or superior to the anti-HBs GMT for the modified process hepatitis B vaccine administered at a dose of 5 µg/0.5 mL. 3. To provide descriptive data for ENGERIX-B™ with respect to anti-HBs as measured by SPR 1 month after the third dose. 4. To assess the safety and tolerability of modified process hepatitis B vaccine when compared with RECOMBIVAX HB™. ; Primary end point(s): Development of gastric and/or duodenal ulcers The key immunogenicity measurement will be the anti-HBs titer at one month after the third dose of vaccine. | — |
Countries
Finland, Norway
Outcome results
None listed