E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
herpes zoster, pneumococcal infection
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019974 |
E.1.2 | Term | Herpes zoster |
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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 |
Main objectives : 1. To determine whether ZOSTAVAX™ administered concomitantly with PNEUMOVAX™ 23 elicits a VZV antibody response that is noninferior to that of ZOSTAVAX™ administered nonconcomitantly. 2. To demonstrate whether ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23. 3. To assess whether PNEUMOVAX™ 23 administered concomitantly with ZOSTAVAX™ elicits serotype-specific pneumococcal antibody responses for serotypes 3, 14, 19A, and 22F that are noninferior to those of PNEUMOVAX™ 23 administered nonconcomitantly
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E.2.2 | Secondary objectives of the trial |
Secondary objective: To assess the safety and tolerability of ZOSTAVAX™ and PNEUMOVAX™ 23 when administered concomitantly. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 60 years or older 2. Signed an informed consent prior to any study procedures 3. Afebrile (<101.0°F [<38.3°C] oral or equivalent) on day of vaccination. 4. Females must be postmenopausal (self-reported) or have a negative urine pregnancy test. 5. Any underlying chronic illness must be in stable condition..
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E.4 | Principal exclusion criteria |
1. A history of allergic reaction to any vaccine component. 2. Prior history of herpes zoster or invasive/culture-positive pneumococcal disease. 3. Prior receipt of any pneumococcal, varicella or zoster vaccine. 4. Any acute intercurrent illness or significant underlying illness that may interfere with the interpretation of the study. 5. Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. 6. Use of immunosuppressive therapy, known or suspected immune dysfunction that is caused by a medical condition or any other cause 7. Any concomitant use of nontopical antiviral therapy with activity against herpesviruses |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity endpoints for varicella zoster virus (VZV) antibody responses • geometric mean titer (GMT) 4 weeks postvaccination of ZOSTAVAX™ • geometric mean foldrise (GMFR) from prevaccination to 4 weeks postvaccination of ZOSTAVAX™ Immunogenicity endpoints for pneumococcal polysaccharide (PnPs) antibody responses - GMT 4 weeks postvaccination of PNEUMOVAX™ 23 Safety endpoints: • Tiered approach will be used to analyze specific adverse experiences o Tier 1: VRC-prompted VZV-like rash, noninjection-site, from Day 1 to Day 28 after each vaccination; and injection-site adverse experiences; VRC-prompted, Day 1 to Day 5 following each vaccination for primary analysis o Tier 2: adverse experiences that are not prompted for on the VRC but reported by ≥1% of subjects in either vaccination group o Tier 3: all other adverse experiences Day 1 to Day 28 following each vaccination will be summarized • Overall rate of serious adverse experiences o Day 1 to Day 28 following each vaccination for primary analysis (risk difference and 95% CI) o All serious adverse experiences will be reported and summarized from the time of enrollment through Visit 3
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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 | No |
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 | 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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |