Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAXâ?¢) in Healthy Adults in India (V211-025)
- Registration Number
- CTRI/2012/08/002922
- Lead Sponsor
- Merck Sharp and Dohme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
A subject will be eligible to participate in this study if all of the following criteria apply:
a.Greater than or equal to 50 years of age.
b.Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
c.Any underlying chronic illness must be in stable condition.
Note: We have entered maximum age of 99 yrs, as there is no upper limit defined in the study protocol, the same is approved by the directorate(DCGI).
A subject will not be eligible to participate in this study if any of the following criteria apply:
a.History of hypersensitivity reaction to any vaccine component
b.Prior history of HZ
c.Previously received a varicella or zoster vaccine
d.Pregnant or breastfeeding
e.Have recently received blood products other than autologous blood transfusion
f.Use of immunosuppressive therapy
g.Known or suspected immune dysfunction
h.Use of nontopical antiviral therapy with activity against herpes virus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method