Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01527370 | Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) | PHASE3 | COMPLETED | 250 | — | — | Oct 31, 2012 | Apr 9, 2013 | Sep 18, 2018 | - | — |
| NCT00322231 | A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014) | PHASE3 | COMPLETED | 101 | — | — | May 1, 2006 | Jul 1, 2007 | Jan 26, 2015 | - | — |
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. |
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...