An Open-label, Single-arm, Phase IV Study Assessing the Immunogenicity and Safety of ZOSTAVAX® at Minimum Release Specification Approaching Expiry Potency in Subjects ≥50 Years Old.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 96
- Primary Endpoint
- Geometric Mean Titre (GMT) of Varicella Antibodies
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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
Arms & Interventions
All Enrolled
Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
Intervention: ZOSTAVAX® (Biological)
Outcomes
Primary Outcomes
Geometric Mean Titre (GMT) of Varicella Antibodies
Time Frame: 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 Outcomes
No secondary outcomes reported