Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Herpes Zoster
Shingles
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
Eligibility Criteria
Inclusion
- No fever on day of vaccination
- Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
- Underlying chronic illnesses must be stable
Exclusion
- History of hypersensitivity reaction to any vaccine component
- Prior receipt of a varicella or zoster vaccine
- Prior history of herpes zoster
- Have recently had another vaccination
- Have recently received blood products other than autologous blood transfusion
- Pregnant or breast feeding
- Use of immunosuppressive therapy
- Known or suspected immune dysfunction
- Use of nontopical antiviral therapy with activity against herpesvirus
Key Trial Info
Start Date :
October 31 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2013
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01527370
Start Date
October 31 2012
End Date
April 9 2013
Last Update
September 18 2018
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