- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444860
ZOSTAVAX(R) Local Registration Trial (V211-019)
June 3, 2015 updated by: Merck Sharp & Dohme LLC
A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan
The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
- Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
- Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
- Subject Must Sign Informed Consent Prior To Any Study Procedure
- Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
- Any Underlying Chronic Illness Must Be In Stable Condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Zostavax
|
A single dose of 0.65 ml of Zostavax injection was given to each study subject
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
Time Frame: prevaccination and 4 weeks postvaccination
|
prevaccination and 4 weeks postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
March 7, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Estimate)
June 4, 2015
Last Update Submitted That Met QC Criteria
June 3, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V211-019
- MKV211-019
- 2007_008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Varicella Virus Infection
-
Asan Medical CenterHanyang University; Kangbuk Samsung Hospital; Eulji University HospitalUnknownReversible Cerebral Vasoconstriction Syndrome | Varicella-zoster Virus InfectionKorea, Republic of
-
Wuerzburg University HospitalRecruitingVaccination; Infection | Zoster VaricellaGermany
-
The University of Hong KongCompletedVaricella Zoster InfectionHong Kong
-
SK Chemicals Co., Ltd.CompletedImmunization; Infection | Varicella ZosterKorea, Republic of
-
Susanne Dam Nielsen, MD, DMScOdense University Hospital; Aarhus University Hospital; Technical University...RecruitingVaricella Zoster Virus Infection | Vaccine-Preventable Diseases | Kidney Transplant; ComplicationsDenmark
-
Zhuhai Trinomab Pharmaceutical Co., Ltd.Not yet recruiting
-
GlaxoSmithKlineCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Radboud University Medical CenterTerminatedVaricella Zoster Virus Infection | Herpes Simplex Virus InfectionNetherlands
-
The HIV Netherlands Australia Thailand Research...Chulalongkorn UniversityCompletedHIV Infections | Varicella-zoster VirusThailand
Clinical Trials on Zoster Vaccine, Live, (Oka-Merck)
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...Merck Sharp & Dohme LLC; Cooperative Clinical Trials in Pediatric Transplantation and other collaboratorsTerminatedKidney Transplant RecipientsUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
University of TorontoCanadian Institutes of Health Research (CIHR); University of Nairobi; Kenyan...Unknown
-
Merck Sharp & Dohme LLCCompletedHerpes Zoster | Pneumococcal Infection
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella