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Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

Phase 4
Completed
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
All EnrolledZOSTAVAX®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
NameTimeMethod
Geometric Mean Titre (GMT) of Varicella AntibodiesPredose (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
NameTimeMethod
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