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.
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
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 April 23, 2014