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 March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01626794
First received: June 8, 2012
Last updated: March 1, 2013
Last verified: March 2013
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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:
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: | March 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 |
| ClinicalTrials.gov Identifier: | NCT01626794 History of Changes |
| Other Study ID Numbers: | V210-062 |
| Study First Received: | June 8, 2012 |
| Last Updated: | March 1, 2013 |
| 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 May 19, 2013