A Phase III Double Blind, Randomized, Multicenter,Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX™ New Seed Process (NSP)Administered Concomitantly with M-M-R™ II

Phase 1

• Conditions: MedDRA version: 19.1Level: LLTClassification code 10069628Term: Varicella immunizationSystem Organ Class: 100000004865; Active immunization for the prevention of varicella in individuals 12 months of age and older; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-001444-35-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 600
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 wit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified