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Sponsored by: |
Merck |
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00130793 |
The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
Condition | Intervention | Phase |
Herpes Zoster |
Biological: V211: zoster vaccine live (Oka/Merck) Biological: Comparator: zoster vaccine live (Oka/Merck) |
Phase III |
MedlinePlus related topics: | Chickenpox Shingles |
ChemIDplus related topics: | Zostavax |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Bio-equivalence Study |
Official Title: | A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck) |
Estimated Enrollment: | 360 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
The duration of treatment is 4 weeks.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_035, V211-010 |
First Received: | August 11, 2005 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00130793 |
Health Authority: | United States: Food and Drug Administration |
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