E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active immunization for the prevention of varicella in individuals 12 months of age and older |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of varicella in individuals 12 months of age and older |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069628 |
E.1.2 | Term | Varicella immunization |
E.1.2 | System Organ Class | 100000004865 |
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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 describe the immunogenicity of VARIVAX™ after:
- Two doses of VARIVAX™, given 6 weeks apart, in adults 18 to 75 years of age (Stage 1).
- Two doses of VARIVAX™, given 6 weeks apart, in adolescents 13 to 17 years of age (Stage 2).
- One dose of VARIVAX™ in children 12 months to 12 years of age (Stage 2). |
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E.2.2 | Secondary objectives of the trial |
To summarize the safety and tolerability of VARIVAX™.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• has a negative clinical history for varicella and herpes zoster
• females of reproductive potential have a negative pregnancy test prior to each study vaccination
• females of reproductive potential remain abstinent or use 2 acceptable methods of birth control during study until 3 months following last study vaccination
• females not of reproductive potential do not require a pregnancy test or use of contraceptives
• legal representative of adult or parent of children understands risks involved with, consent to participate in, and comply with the study procedures
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E.4 | Principal exclusion criteria |
• has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any component of VARIVAX^TM
• has received any form of varicella or herpes zoster vaccine at any time prior to study, or anticipates receiving any during study
• has received immune globulin, a blood transfusion or blood derived products within prior 5 months or plans to do so during study
• has received aspirin or any aspirin-containing products within prior 14 days
• has been exposed to varicella or herpes zoster in the prior 4 weeks involving playmate, hospital or continuous household contact, or had contact with a newborn whose mother had chickenpox 5 days before or 2 days after delivery
• has, or lives with a person who has, any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity including those resulting from corticosteroid use or other immunosuppressive therapy
• has received glucocorticosteroids for more than 5 consecutive days within prior 3 months, or any dose of glucocorticoids within prior 7 days, or expects to use glucocorticosteroids during the study
• was vaccinated with licensed non-live or live vaccine within prior 30 days or expects vaccination during 42 day follow-up postvaccination period
• had a fever within 72 hours prior to study vaccination
• has participated in another trial within prior 30 days, is currently participating in another trial, or plans to participate in another trial during the planned study period for this trial
• is pregnant or nursing
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Varicella Zoster Virus (VZV) Antibody Response Rate
2. VZV Antibody Titer
3. VZV Antibody Seroconversion Rate
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 6 weeks post-final vaccination (1-12 years old: 6 weeks; 13 years and older: 12 weeks)
2. 6 weeks post-final vaccination (1-12 years old: 6 weeks; 13 years and older: 12 weeks)
3. 6 weeks post-final vaccination (1-12 years old: 6 weeks; 13 years and older: 12 weeks)
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E.5.2 | Secondary end point(s) |
1. Solicited injection-site reactions
2. Unsolicited injection-site adverse experiences
3. Elevated Temperature
4. Varicella-like and herpes zoster-like rashes
5. Systemic adverse experiences
6. Serious adverse experiences
7. Vaccine-related serious adverse experiences
8. Vaccine-related death
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 5 days after each vaccination
2. Up to 42 days after each vaccination
3. Up to 28 days after each vaccination
4. Up to 42 days after each vaccination
5. Up to 42 days after each vaccination
6. Up to 42 days after each vaccination
7. Up to 42 days after each vaccination
8. Up to 42 days after each vaccination
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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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | 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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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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The overall study ends when the last participant completes the last study-related telephonecall or visit, withdraws from the study, or is lost to follow-up |
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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 | 2 |