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

NCT ID: NCT01626794

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Varicella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

VARIVAX™ VEP

Group Type: EXPERIMENTAL

VARIVAX™ VEP

Intervention Type: BIOLOGICAL

Two 0.5 mL subcutaneous doses administered on Days 1 and 91

M-M-R™ II

Intervention Type: BIOLOGICAL

Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

VARIVAX™ 2007 Process

Group Type: ACTIVE_COMPARATOR

VARIVAX™ 2007 Process

Intervention Type: BIOLOGICAL

Two 0.5 mL subcutaneous doses administered on Days 1 and 91

M-M-R™ II

Intervention Type: BIOLOGICAL

Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

Interventions

VARIVAX™ VEP

Two 0.5 mL subcutaneous doses administered on Days 1 and 91

Intervention Type: BIOLOGICAL

VARIVAX™ 2007 Process

Two 0.5 mL subcutaneous doses administered on Days 1 and 91

Intervention Type: BIOLOGICAL

M-M-R™ II

Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

V210-062

Identifier Type: -

Identifier Source: org_study_id