Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zoster Vaccine, Live · 6 trials · 5 indications
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.
Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.
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 |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to receive Placebo. |
| 1 | PLACEBO_COMPARATOR | Placebo Comparator |
| 2 | EXPERIMENTAL | vaccine |
| 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 (Zostavax™) | BIOLOGICAL | A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1. |
| Comparator: Placebo | BIOLOGICAL | A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection 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. |
| Zoster Vaccine, Live, (Oka-Merck) | BIOLOGICAL | A single dose of 0.65 ml of Zostavax injection was given to each study subject |
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...
Zoster Vaccine, Live is a vaccine used to prevent shingles, herpes zoster, and varicella virus infection. It is being developed by Merck & Company, Inc. for adults aged 50 years and older. The vaccine is intended to reduce the risk of developing these conditions.
Zoster Vaccine, Live is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company has conducted multiple clinical trials to evaluate the vaccine's safety and effectiveness in preventing shingles and related conditions.
Zoster Vaccine, Live is in Phase 3 clinical development. It has completed four trials, including three Phase 3 studies and one Phase 2 study. All trials have been completed, with no active trials currently ongoing. The vaccine remains investigational and is not yet approved.
Zoster Vaccine, Live has completed four clinical trials. These include NCT00444860, a Phase 3 local registration trial; NCT00534248, a Phase 3 study in subjects aged 50-59; NCT00535730, a Phase 3 trial with concomitant pneumococcal vaccine; and NCT00546819, a Phase 2 study in patients on corticosteroids.
Yes, Zoster Vaccine, Live is the same as ZOSTAVAX. Several clinical trials, including NCT00534248 and NCT00535730, refer to the vaccine as ZOSTAVAX. The vaccine is being developed by Merck & Company, Inc. for the prevention of shingles and herpes zoster.
Zoster Vaccine, Live is a live attenuated vaccine that works by stimulating the immune system to produce a protective response against the varicella-zoster virus. This virus causes chickenpox and can later reactivate to cause shingles. The vaccine helps the body recognize and fight the virus.