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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01505647 | Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1) | PHASE3 | COMPLETED | 498 | — | — | Apr 1, 2012 | Nov 1, 2012 | Apr 12, 2017 | - | — |
| NCT01245751 | Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029) | PHASE3 | COMPLETED | 600 | — | — | Apr 1, 2011 | May 1, 2015 | Apr 12, 2017 | - | — |
| NCT00535730 | ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED) | PHASE3 | COMPLETED | 473 | — | — | Jun 1, 2007 | Feb 1, 2008 | Apr 12, 2017 | - | — |
| NCT00546819 | ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED) | PHASE2 | COMPLETED | 309 | — | — | Oct 1, 2007 | Aug 1, 2010 | Apr 12, 2017 | - | — |
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. \*gpELISA = glycoprotein enzyme-linked immunosorbent assay
GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23. gpELISA = glycoprotein enzyme-linked immunosorbent assay.
GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
| Arm | Type | Description |
|---|---|---|
| ZOSTAVAX™ (AMP) | EXPERIMENTAL | ZOSTAVAX™ manufactured with an alternative process |
| ZOSTAVAX™ | ACTIVE_COMPARATOR | ZOSTAVAX™ manufactured with the current process |
| Group 1: Booster Dose Participants ≥70 years of age | EXPERIMENTAL | Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501) |
| Group 2: First Dose Participants ≥70 years of age | EXPERIMENTAL | Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age |
| Group 3: First Dose Participants ≥60 and <70 years of age | EXPERIMENTAL | Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live |
| Group 4: First Dose Participants ≥50 and <60 years of age | EXPERIMENTAL | Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live |
| 1 | PLACEBO_COMPARATOR | Placebo Comparator |
| 2 | EXPERIMENTAL | vaccine |
| Placebo | PLACEBO_COMPARATOR | Participants administered Placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| Zoster Vaccine, Live (AMP) | BIOLOGICAL | One approximately 0.65-mL injection subcutaneously on Day 1 |
| Zoster Vaccine, Live | BIOLOGICAL | One approximately 0.65-mL injection subcutaneously on Day 1 |
| Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ | BIOLOGICAL | 0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period |
| Comparator: placebo (concomitant-vaccine matched) | BIOLOGICAL | Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period. |
| Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23 | BIOLOGICAL | Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period. |
| Comparator: Placebo | BIOLOGICAL | A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1. |
Inclusion Criteria: * No fever on day of vaccination * History of varicella or residence in a VZV-endemic area for ≥30 years * Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control Exclusion Criteria: * History of hypersens...