Status:
COMPLETED
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Herpes Zoster
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Primary objective: To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured ...
Eligibility Criteria
Inclusion
- Participant of either gender aged ≥50 years
- Positive history of varicella or residence for \>30 years in a country with endemic VZV infection
- All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination
- Participant having signed the informed consent form prior to any study procedure
Exclusion
- Febrile within 72 hours prior to vaccination
- Prior history of Herpes Zoster clinically diagnosed by a physician
- Previously received a varicella or zoster vaccine
- Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
- Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
- Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
- Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study
- Taking any non topical antiviral therapy with activity against herpesviruses.
- On immunosuppressive therapy
- Known or suspected immune dysfunction caused by a medical condition, or any other cause
- History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
- Known active tuberculosis
- Significant underlying illness preventing completion of the study
Key Trial Info
Start Date :
May 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00681031
Start Date
May 14 2008
End Date
June 25 2008
Last Update
June 29 2021
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