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

Varicella Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01626794
• Other study ID #: V210-062
• Status: Withdrawn
• Phase: Phase 3
• First received: June 8, 2012
• Last updated: January 26, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 23 Months

Eligibility

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

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• VARIVAX™ VEP
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
• VARIVAX™ 2007 Process
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
• M-M-R™ II
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants with VZV antibody levels =5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL		Six weeks (43 days) after vaccination 1	No
Secondary	Percent of participants with fever (=102.2°F [39.0°C] oral equivalent)		Days 1 to 42 after each vaccination	Yes
Secondary	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	Yes
Secondary	Percent of participants with injection-site reactions		Days 1 to 5 after each vaccination	Yes