Status:
COMPLETED
Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Herpes Zoster
Shingles
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
Eligibility Criteria
Inclusion
- No fever on day of vaccination
- History of varicella or residence in a VZV-endemic area for ≥30 years
- Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control
Exclusion
- History of hypersensitivity reaction to any vaccine component
- Prior receipt of any varicella or zoster vaccine
- Prior history of herpes zoster
- Have recently had another vaccination
- Pregnant or breastfeeding
- Use of immunosuppressive therapy
- Known or suspected immune dysfunction
- Concomitant antiviral therapy
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT01505647
Start Date
April 1 2012
End Date
November 1 2012
Last Update
April 12 2017
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