E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019731 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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™.
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
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E.3 | Principal inclusion criteria |
Healthy male and female infants ~2 months of age (40 to 80 days). |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The key immunogenicity measurement will be the anti-HBs titer at one month after the third dose of vaccine.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability and Immunogenicity |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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A subject is defined as having completed the study when all scheduled vaccinations have been received, the safety follow-up completed (i.e., all VRC are returned to the investigator), and the post-Dose 3 blood sample obtained. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |