E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019731 |
E.1.2 | Term | Hepatitis B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 determine in healthy full-term neonates vaccinated at birth (up to 10 days of age), 1 month after Dose 1, and 6 months after Dose 1, whether the antibody to hepatitis B surface antigen (anti-HBs) geometric mean titer (GMT) for the recombinant Hepatitis B vaccine manufactured with 2X phosphate adjuvant (the modified process hepatitis B vaccine) is non-inferior, or is superior when compared to RECOMBIVAX HB™ at Month 7, one month after the third dose of vaccine |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of the modified process hepatitis B vaccine in healthy full-term neonates and infants |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age), born to mothers with documented negative test for HBsAg within 9 months prior to delivery. |
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E.4 | Principal exclusion criteria |
a. Infant born to a mother with no prenatal care.
b. Known or suspected impairment of immunologic function
c. Prior Vaccination with any hepatitis B vaccine for infant or mother (within 6
months prior to the birth of the infant).
d. Recent (<72 hours) history of febrile illness ≥99.5°F (≥37.5°C) axillary or
≥100.5°F (≥38.1°C) rectal.
e. Any prior administration of hepatitis B immune globulin (HBIG), serum
immune globulin, or any other blood-derived product, or the receipt by the
mother of either immunoglobulin or HBIG within 6 months prior to birth of
the infant.
f. Receipt of investigational drugs or other investigational vaccines by mother or
infant within 3 months prior to first injection with the study vaccine or if
scheduled to be given to the infant during the study.
g. Known or suspected hypersensitivity to any component of RECOMBIVAX
HB™ (e.g., aluminum, yeast).
h. Any infant who cannot be adequately followed for study visits during the
course of the clinical study.
i. 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 primary immunogenicity variable of interest for the comparison of the modified process vaccine and RECOMBIVAX HB™ is the ratio of the anti-HBs GMT for the modified process vaccine over the current process vaccine (GMTmodified process vaccine/GMTcurrent process vaccine) at 7 months.
Two other endpoints to be computed for each group at the 7-month time point is the proportion of subjects with a seroprotective level of anti-HBs (an anti-HBs titer ≥10 mIU/mL) and with any detectable anti-HBs (an anti-HBs titer ≥5 mIU/mL) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Anti-HBs SPRs, the proportions of subjects with any detectable anti-HBs ( anti-HBs titer ≥5 mIU/mL) and the GMTs will be summarized at Month 7 by group with the corresponding two-sided 95 % confidence intervals. Confidence intervals for the difference in proportion of subjects above will be constructed according to the methodology of Miettinen and Nurminen [3]. Estimates will be stratified by site. Exploratory analyses of immunologic endpoints of subgroups defined by the use of concomitant vaccines may be considered, if appropriate. In addition, the distribution of anti-HBs titers for each group at Month 7 will also be
examined by reverse cumulative distribution functions (RCDFs). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.2 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |