E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of herpes zoster in adults with autoimmune disease |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of shingles in adults with an illness occurring when the body tissues are attacked by its own immune system |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 whether V212 from three consistency lots have similar immunogenicity. |
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E.2.2 | Secondary objectives of the trial |
To determine the safety and tolerability of V212 from three consistency lots. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
VZV whole blood cytokine stimulation assay substudy will enroll a subset of ~60 subjects to evaluate the level of total interferon gamma (IFN-γ) secretion from whole blood cells as measured by VZV WBStim assay at 28 days Postdose 4 and to explore the correlation, if any, between the VZV antibody measured by gpELISA and IFN-γ secretion measured by the VZV WBStim assay can be determined. |
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E.3 | Principal inclusion criteria |
1. Be 50 to 59 years of age (at time of informed consent)
2 .Be afebrile (≤100.4° F[≤38.0°C]) oral or equivalent on Day 1 prior to first vaccination.
Note: Should a subject meets all additional inclusion/exclusion criteria requiring for entry into the study but are currently febrile, then enrollment may be delayed until the above criteria is met.
3. Any underlying chronic illness must be in stable condition.
4. Have a history of varicella, antibodies to VZV, or residence (for ≥30 years) in a country with endemic VZV infection.
5. All female subjects of childbearing potential must have a negative serum or urine pregnancy test (sensitive to 25 IU β-hCG).
6. Be highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose.
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E.4 | Principal exclusion criteria |
1. Has a prior history of HZ.
2. Has had prior receipt or any expected receipt during the study period of any varicella or zoster vaccine.
3. Has had any live virus vaccine administered or is scheduled to receive any live virus vaccine in the period from 4 weeks prior to Visit 1 through Visit 5.
4. Any inactivated vaccine administered or is scheduled to receive within the period from 7 days prior, through 7 days following any dose of study vaccine.
5. Has had immunoglobulin or any blood products administered or is scheduled to receive immunoglobulin or any blood products in the period from 5 months prior to Visit 1 through Visit 5.
6. Is receiving immunosuppressive therapy.
7. Has known or suspected immune dysfunction that is caused by a medical condition, or any other cause
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E.5 End points |
E.5.1 | Primary end point(s) |
Geometric mean titer (GMT) in VZV gpELISA antibody titers measured at 28 days Postdose 4 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 (prior to Dose 1) and 28 days Postdose 4 |
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E.5.2 | Secondary end point(s) |
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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 | No |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Immunologic response to vaccine |
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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) | 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.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Blinding of three (3) separate manufactured lots of V212 that will be administered |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | No |
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 | 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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |