Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
- Conditions
- Herpes Zoster
- Interventions
- Biological: ZOSTAVAX®
- Registration Number
- NCT00681031
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination.
Secondary objectives:
To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Enrolled ZOSTAVAX® Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
- Primary Outcome Measures
Name Time Method Geometric Mean Titre (GMT) of Varicella Antibodies Predose (Day 0) and Day 28-35 Post Dose Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).
- Secondary Outcome Measures
Name Time Method