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Also known as zoster vaccine live (ZOSTAVAX™), ZOSTAVAX™, V211
zoster vaccine live · 3 trials · 2 indications
Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
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.
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.
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
| Arm | Type | Description |
|---|---|---|
| Zoster Vaccine Live | EXPERIMENTAL | - |
| ZOSTAVAX™ / Placebo | EXPERIMENTAL | Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2) |
| Placebo / ZOSTAVAX™ | EXPERIMENTAL | Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2) |
| Name | Type | Description |
|---|---|---|
| Zoster Vaccine Live | BIOLOGICAL | One approximately 0.65 mL injection subcutaneously on Day 1 |
| zoster vaccine live (ZOSTAVAX™) | BIOLOGICAL | 1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live |
| Comparator: Placebo | BIOLOGICAL | 1 dose 0.65 mL/dose subcutaneous injection of placebo. |
| zoster vaccine live (Oka/Merck) | BIOLOGICAL | - |
| Comparator: placebo (unspecified) | BIOLOGICAL | - |
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 * Pr...
Zoster vaccine live is a vaccine intended for the prevention of herpes zoster, commonly known as shingles. It is studied in adults aged 50 years and older, including those with a history of herpes zoster. The vaccine is designed to reduce the risk of shingles in this population.
Zoster vaccine live is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical trials evaluating this vaccine for herpes zoster and shingles.
Zoster vaccine live has been evaluated in Phase 3 clinical trials. Two completed Phase 3 studies and one completed Phase 2 study have been conducted. The vaccine remains an investigational product and is not approved for use.
Zoster vaccine live has been studied in completed trials including NCT01527370, a Phase 3 study in healthy adults in India, and NCT00322231, a Phase 3 study in subjects with a history of herpes zoster. A Phase 2 trial, NCT00109122, enrolled 180 participants.
Zoster vaccine live is also known as zoster vaccine live (Oka/Merck) and zoster vaccine live (ZOSTAVAX). These names refer to the same vaccine product developed by Merck. ZOSTAVAX is a trademarked name for this formulation.