E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis B ICD10 classification code : Hepatitis Viral- Type B (ICD10- B16) MedDRA classification code : Infections and Infestations – Viral Hepatitis B
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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 |
(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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | No |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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.8.3 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 is completed (i.e., all VRC are returned to the investigator), and all blood samples have been 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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
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 |