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

January 26, 2015 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: M-M-R™ II
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
Biological: VARIVAX™ 2007 Process
Two 0.5 mL subcutaneous doses administered on Days 1 and 91

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Six weeks (43 days) after vaccination 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)
Time Frame: Days 1 to 42 after each vaccination
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
Time Frame: Days 1 to 42 after each vaccination
Days 1 to 42 after each vaccination
Percent of participants with injection-site reactions
Time Frame: Days 1 to 5 after each vaccination
Days 1 to 5 after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V210-062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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