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

Phase 3

Withdrawn

• Conditions: Varicella
• Interventions: Biological: VARIVAX™ VEP; Biological: VARIVAX™ 2007 Process; Biological: M-M-R™ II

• Registration Number: NCT01626794
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Study Start: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VARIVAX™ VEP	VARIVAX™ VEP	-
VARIVAX™ VEP	M-M-R™ II	-
VARIVAX™ 2007 Process	M-M-R™ II	-
VARIVAX™ 2007 Process	VARIVAX™ 2007 Process	-

Primary Outcome Measures

Name	Time	Method
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL	Six weeks (43 days) after vaccination 1

Secondary Outcome Measures

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