Varicella
Conditions
Brief summary
This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.
Interventions
BIOLOGICALVARIVAX™ VEP
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
BIOLOGICALVARIVAX™ 2007 Process
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
BIOLOGICALM-M-R™ II
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* negative clinical history of measles, mumps, rubella, varicella, and zoster
Exclusion criteria
* received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study * any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity * received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study * history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™ * received salicylates within 14 days prior to study vaccination * exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination * received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination * received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination * received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination * fever illness (≥102.2°F \[39.0°C\]) within 72 hours prior to study vaccination * born to a human immunodeficiency virus (HIV)-infected mother * participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL | Six weeks (43 days) after vaccination 1 |
Secondary
| Measure | Time frame |
|---|---|
| Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent) | Days 1 to 42 after each vaccination |
| Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms | Days 1 to 42 after each vaccination |
| Percent of participants with injection-site reactions | Days 1 to 5 after each vaccination |
Outcome results
None listed