Clinical trial NCT01626794: A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)
Official title: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
timeFrame: Six weeks (43 days) after vaccination 1
Secondary outcomes:
measure: Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)
timeFrame: Days 1 to 42 after each vaccination
measure: Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms
timeFrame: Days 1 to 42 after each vaccination
measure: Percent of participants with injection-site reactions
timeFrame: Days 1 to 5 after each vaccination
Other outcomes:
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