A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)
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)
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2014
Shorter than P25 for phase_3
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJanuary 27, 2015
January 1, 2015
1.3 years
June 8, 2012
January 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
Six weeks (43 days) after vaccination 1
Secondary Outcomes (3)
Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)
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
Days 1 to 42 after each vaccination
Percent of participants with injection-site reactions
Days 1 to 5 after each vaccination
Study Arms (2)
VARIVAX™ VEP
EXPERIMENTALVARIVAX™ 2007 Process
ACTIVE COMPARATORInterventions
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
Eligibility Criteria
You may qualify if:
- negative clinical history of measles, mumps, rubella, varicella, and zoster
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 25, 2012
Study Start
July 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
January 27, 2015
Record last verified: 2015-01