A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 250
- Primary Endpoint
- Number of Participants With Serious Adverse Events
Study Overview
Brief Summary
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
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
- •No fever on day of vaccination
- •Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
- •Underlying chronic illnesses must be stable
Exclusion Criteria
- •History of hypersensitivity reaction to any vaccine component
- •Prior receipt of a varicella or zoster vaccine
- •Prior history of herpes zoster
- •Have recently had another vaccination
- •Have recently received blood products other than autologous blood transfusion
- •Pregnant or breast feeding
- •Use of immunosuppressive therapy
- •Known or suspected immune dysfunction
- •Use of nontopical antiviral therapy with activity against herpesvirus
Outcomes
Primary Outcomes
Number of Participants With Serious Adverse Events
Time Frame: Up to 42 days postvaccination
A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
Time Frame: Prevaccination up to 6 weeks postvaccination
Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
Time Frame: Prevaccination up to 6 weeks postvaccination
GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
Secondary Outcomes
No secondary outcomes reported