A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01626794
First received: June 8, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Varicella
Biological: VARIVAX™ VEP
Biological: VARIVAX™ 2007 Process
Biological: M-M-R™ II
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL [ Time Frame: Six weeks (43 days) after vaccination 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent) [ Time Frame: Days 1 to 42 after each vaccination ] [ Designated as safety issue: Yes ]
  • Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms [ Time Frame: Days 1 to 42 after each vaccination ] [ Designated as safety issue: Yes ]
  • Percent of participants with injection-site reactions [ Time Frame: Days 1 to 5 after each vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 520
Study Start Date: July 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VARIVAX™ VEP Biological: VARIVAX™ VEP
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
Biological: M-M-R™ II
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
Active Comparator: VARIVAX™ 2007 Process Biological: VARIVAX™ 2007 Process
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
Biological: M-M-R™ II
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01626794     History of Changes
Other Study ID Numbers: V210-062
Study First Received: June 8, 2012
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014