A Phase 3 interventional study of zoster vaccine live (ZOSTAVAX™) and Comparator: Placebo in Herpes Zoster, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 101 is close to the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
Biological: zoster vaccine live (ZOSTAVAX™) · Biological: Comparator: Placebo
Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
Biological: zoster vaccine live (ZOSTAVAX™) · Biological: Comparator: Placebo
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
Also known as: Zostavax
1 dose 0.65 mL/dose subcutaneous injection of placebo.
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
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
Time frame: To Day 28 postvaccination
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Time frame: 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Time frame: From prevaccination (baseline) to 4 weeks postvaccination
Patients were recruited at 9 sites in the United States. First patient enrolled: May-2006; Last patient last visit: July - 2007
| Milestone | ZOSTAVAX™ / Placebo | Placebo / ZOSTAVAX™ |
|---|---|---|
| Started | 51 | 50 |
| Completed | 51 | 50 |
| Not completed | 0 | 0 |
| Milestone | ZOSTAVAX™ / Placebo | Placebo / ZOSTAVAX™ |
|---|---|---|
| Started | 51 | 49 |
| Completed | 51 | 49 |
| Not completed | 0 | 0 |
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
| Participants | ZOSTAVAX™ | Placebo |
|---|---|---|
| With Vaccine-related SAEs | 0 | 0 |
| Without Vaccine-related SAEs | 100 | 101 |
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
| gpELISA units/mL | ZOSTAVAX™ | Placebo |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | 810.1 (688.3 to 953.4) | 391.1 (291.9 to 523.9) |
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
| Geometric mean fold rise | ZOSTAVAX™ | Placebo |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination | 2.1 (1.8 to 2.4) | 1.0 (0.9 to 1.1) |
Collected over Day 1 - 28 following each vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZOSTAVAX™ | — | 0/98 (0%) | 45/98 (45.9%) |
| Placebo | — | 0/96 (0%) | 4/96 (4.2%) |
| Event | ZOSTAVAX™ | Placebo |
|---|---|---|
| Injection Site PainGeneral disorders | 36/98 | 1/96 |
| Injection Site ErythemaGeneral disorders | 33/98 | 3/96 |
| Injection Site SwellingGeneral disorders | 26/98 | 2/96 |
| Injection Site PruritusGeneral disorders | 5/98 | 0/96 |
| Age, Customized(participants) | ZOSTAVAX™ / Placebo | Placebo / ZOSTAVAX™ | Total |
|---|---|---|---|
| 50 to 59 Years of age | 10 | 10 | 20 |
| ≥ 60 Years of age | 41 | 40 | 81 |
| Sex: Female, Male(Participants) | ZOSTAVAX™ / Placebo | Placebo / ZOSTAVAX™ | Total |
|---|---|---|---|
| Female | 36 | 24 | 60 |
| Male | 15 | 26 | 41 |
| Race/Ethnicity, Customized(participants) | ZOSTAVAX™ / Placebo | Placebo / ZOSTAVAX™ | Total |
|---|---|---|---|
| Asian | 1 | 3 | 4 |
| Black | 3 | 3 | 6 |
| Hispanic American | 0 | 2 | 2 |
| White | 47 | 42 | 89 |
No study locations are listed for this record.
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Merck Sharp & Dohme LLC