Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
University of Colorado, Denver
Duke University
Conditions:
Herpes Zoster
Varicella-zoster Vaccine
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to simila...
Detailed Description
All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.
Eligibility Criteria
Inclusion
- All Groups:
- Must not have a fever of ≥100.4° F on the day of vaccination
- Any underlying chronic illness must be in stable condition
- History of varicella or residence in a VZV-endemic area for ≥30 years
- Group 1:
- 70 years of age or older
- Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
- Group 2:
- 70 years of age or older
- Group 3:
- 60 to 69 years of age
- Group 4:
- 50 to 59 years of age
Exclusion
- All Groups:
- History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
- Prior history of herpes zoster
- Pregnant or breast-feeding, or expecting to conceive within the duration of the study
- Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
- Received any other vaccine within 4 weeks prevaccination
- On immunosuppressive therapy
- Has known or suspected immune dysfunction
- Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
- Groups 2, 3, and 4:
- Has previously received any varicella or zoster vaccine
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01245751
Start Date
April 1 2011
End Date
May 1 2015
Last Update
April 12 2017
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