Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational vaccine used for the prevention of herpes zoster, commonly known as shingles. It is being studied in healthy adults aged 50 years and older to evaluate its safety, tolerability, and ability to generate an immune response against the varicella-zoster virus.
Zoster vaccine live is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is currently in clinical development and has not yet been approved by regulatory authorities.
Zoster vaccine live is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 2 trial, with a total enrollment of 351 participants across all studies. The vaccine remains investigational and is not yet approved for public use.
Zoster vaccine live has been studied in three completed clinical trials: NCT00109122, a Phase 2 safety and immunogenicity study in 180 adults aged 60 years and older; NCT00322231, a Phase 3 study in 101 adults with a history of herpes zoster; and NCT01527370, a Phase 3 study in 250 healthy adults in India.
Yes, zoster vaccine live is also known as ZOSTAVAX. The Phase 3 trial NCT01527370 specifically evaluated the safety, tolerability, and immunogenicity of Zoster Vaccine Live (ZOSTAVAX) in healthy adults in India, confirming that these names refer to the same investigational vaccine.