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 | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019974 |
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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 |
1) To determine whether ZOSTAVAX™ administered concomitantly with influenza vaccine in subjects 50 years of age or older elicits a VZV antibody response that is noninferior to that of ZOSTAVAX™ administered alone. 2) To demonstrate whether ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with influenza vaccine in subjects 50 years of age or older. 3) To assess whether influenza vaccine administered concomitantly with ZOSTAVAX™ in subjects 50 years of age or older elicits strain-specific influenza antibody responses that are noninferior to those of influenza vaccine administered alone.
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of ZOSTAVAX™ when administered concomitantly with influenza vaccine in subjects 50 years of age or older. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Age ≥ 50 years • Signed inform consent prior to any study procedure • Afebrile (<101.0°F [<38.3°C]) oral or equivalent on day of vaccination. • Any underlying chronic illness must be in stabilized. • All females must be postmenopausal or have a negative serum or urine pregnancy test
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E.4 | Principal exclusion criteria |
• History of hypersensitivity reaction to any vaccine component, including gelatine, neomycin, egg proteins, or chicken proteins • Prior history of HZ • Prior history of any varicella or zoster vaccine • Subject is pregnant or breastfeeding or expecting to conceive within projected duration of the study. • Immunoglobulin or nay blood products administered or scheduled in the period from 5 months prior to vaccination through Visit 3 • Any live virus vaccine administered or scheduled in the period from 4 weeks prior to vaccination through Visit 3. • Any inactivated vaccine administered or scheduled in the period from 7 days prior to vaccination through Visit 3. • Participation in an investigational drug or vaccine study within the last 30 days prevaccination. • Any acute intercurrent illness that might interfere with the interpretation of the study. • Significant underlying illness preventing completion of the study. • Use of immunosuppressive therapy. • Known or suspected immune dysfunction that is caused by a medical condition, or any other cause. • Any concomitant use of nontopical antiviral therapy with activity against herpes viruses. • A history of alcohol abuse or recreational drug use which, in the opinion of the investigator, will interfere with study participation. • Any influenza vaccine administered for the 2005-2006 flu season.
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E.5 End points |
E.5.1 | Primary end point(s) |
• The primary immunogenicity endpoints are the geometric mean titers (GMTs) of VZV antibodies by gpELISA and GMTs of the strain-specific influenza antibodies by HAI for each of the 3 strains contained in the influenza vaccine at 4 weeks postvaccination. • The endpoint for the acceptance hypothesis is the geometric mean fold rise (GMFR) of VZV antibody titers from prevaccination to week 4 postvaccination in the concomitant group
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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 | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
tolerability, immunogenicity and concomitant use with influenza vaccine. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open Label Influenza Vaccine |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | Yes |
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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The last visit of the last subject is the end of the trail. |
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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 | 2 |
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 | 2 |