| 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 |
| Active immunization for the 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 | 20.0 |
| 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 |
1) To demonstrate that a single dose of VARIVAX™ NSP induces VZV antibody responses 6 weeks Postdose 1 that are non-inferior to those induced by VARIVAX™ manufactured with the currently approved 2007 process (VARIVAX™ 2007 process).
2) The second primary immunogenicity endpoint is the VZV antibody GMTs.
3) To demonstrate that a single dose of VARIVAX™ NSP induces an acceptable antibody response rate to VZV 6 weeks Postdose 1.
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| E.2.2 | Secondary objectives of the trial |
1) To assess the safety and tolerability of the first and second doses of VARIVAX™ NSP when administered to children 12 to 23 months of age.
2) To summarize the antibody response to VZV among children after 1 dose of VARIVAX™ NSP and among children after 1 dose of VARIVAX™ 2007 process.
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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 |
Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described
elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases
and/or their therapeutic treatments. The overarching goal is to use such nformation to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time. |
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| E.3 | Principal inclusion criteria |
1. Be 12 to 23 months of age upon receipt of the first study vaccination (subject is able to enroll up to 1 day prior to his/her second birthday).
2. Be in good health based on medical history.
3. Have a negative clinical history for varicella, herpes zoster (HZ), measles, mumps and rubella.
4. Be able to complete all scheduled visits and comply with the study procedures.
The subject’s legal representative must:
5. Understand the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
6. Be able to read, understand, and complete study questionnaires (e.g. Vaccination Report Card [VRC]).
7. The subjects' parent/legal guardian may also provide written informed consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
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| E.4 | Principal exclusion criteria |
If a subject meets any of the exclusion criteria marked with an asterisk (*), the Day 1 visit may be rescheduled for a time when these criteria are no longer met.
1. Has received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines, either alone or in any combination, during the study.
2. Has any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including those resulting from corticosteroid use or other immunosuppressive therapy.
3. Has received 1) systemic immunomodulatory steroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone or equivalent or >20 mg/day of prednisone or equivalent for subjects weighing >10 kg) within 3 months prior to entering study, or 2) any dose of systemic steroids within 7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids during the course of the study. Exception: Subjects using non-systemic steroids (e.g. topical, ophthalmic, inhaled) will be eligible for vaccination.
4. Has a history of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins (egg or egg products), chicken proteins or any component of VARIVAX™ or M-M-R™ II as stated in the package circulars.
5. Has received salicylates (e.g. aspirin or any aspirin-containing products) within 14 days prior to vaccination.
6. Has had an exposure to varicella, HZ, measles, mumps or rubella in the last 4 weeks prior to the study vaccination involving: a. Continuous household contact, or b. Playmate contact, (generally >1 hour of play indoors) or c. Hospital contact (in the same 2- to 4-bed room or in adjacent beds in a large ward or prolonged face-to-face contact with an infectious staff member or patient), or d. Contact with a newborn whose mother had onset of chickenpox 5 days or less before delivery or within 48 hours after delivery.
7. *Was vaccinated with a licensed, non-live vaccine (e.g., Inactivated Poliovirus [IPV], Diphtheria, Tetanus, and Acellular Pertussis [DTaP], Haemophilus influenzae type b [Hib]) 14 days or less prior to any dose of the study vaccines or is expected to be vaccinated during the 42-day safety follow-up period after each study vaccination.
8. *Was vaccinated with any licensed live vaccine 30 days or less prior to any dose of the study vaccines or is expected to be vaccinated within the 42-day safety follow-up period after each study vaccination.
9. Has received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months prior to vaccination or plans to receive these products while enrolled in this study.
10. Has a history of seizure disorder, including single febrile seizure.
11. *Has a recent (within 72 hours) febrile illness (≥102.2°F [39.0°C] oral equivalent) prior to the study vaccination. Temperature may be converted to oral equivalent by adding 1.0°F to axillary temperatures and subtracting 1.0°F from rectal temperatures.
12. Has a history of thrombocytopenia.
13. Was born to an HIV-infected mother.
14. Is currently participating in (30 days or less prior to enrollment) or scheduled to participate in any other clinical trial other than a surveillance study during the planned study period for this trial.
15. Has any other underlying medical condition that, in the opinion of the investigator, may interfere with the evaluation of study objectives.
16. Has an immediate family member (parent or sibling) who is an investigational site staff member or sponsor staff member directly involved with this trial.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary endpoints to address the primary immunogenicity objectives are:
•The percent of subjects with VZV antibody titer ≥5 gpELISA units/mL 6 weeks
Postdose 1 among subjects whose baseline VZV antibody titer is <1.25 gpELISA
units/mL.
•The postvaccination VZV antibody GMT 6 weeks Postdose 1
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
The VZV immunogenicity data will be summarized for the antibody response rates, risk difference in response rates, seroconversion rates, geometric mean titers (GMTs) and the associated 95% CI for these parameters.
The primary safety endpoints are: the rate of fever (temperature ≥102.2°F [≥39.0°C] oral equivalent) from Days 1 to 42 after each vaccinatio n; varicella-like, zoster-like, measles-like or rubella-like rashes or mumps-like symptoms occurring within Days 1 to 42 after each vaccination; and solicited injection-site reactions (redness, swelling, pain/tenderness) within Days 1 to 5 after each vaccination.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Day 1 through Day 5 following each vaccination, Day 1 through Day 42 following each vaccination, Day 1 through Day 271 (180 days Postdose 2) |
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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 | Yes |
| 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 | 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 | Yes |
| 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 |
| Same vaccine made with an alternative manufacturing process |
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| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial months | 18 |
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