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Also known as Zoster Vaccine, Live, (Oka-Merck), Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™, Zoster Vaccine, Live, ZOSTAVAX, Zoster Vaccine, Live (AMP), Zoster Vaccine, Live (Zostavax™)
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 used to prevent herpes zoster, commonly called shingles, and varicella virus infection. It is a live vaccine developed by Merck & Company, Inc. for adults, with clinical trials enrolling participants aged 50 years and older. The vaccine is studied for reducing the risk of shingles and related varicella-zoster complications.
Zoster Vaccine, Live is developed and manufactured by Merck & Company, Inc., which trades under the ticker MRK. Merck conducted the clinical development program for this vaccine, including trials evaluating an alternative manufacturing process and a booster dose. The vaccine is also known by the brand name ZOSTAVAX.
Yes, Zoster Vaccine, Live is the same as ZOSTAVAX. ZOSTAVAX is the brand name for Merck's live zoster vaccine, and the two names refer to the same product. Other listed names include Zoster Vaccine, Live (Oka-Merck) and Zoster Vaccine, Live (AMP), which refers to a version made with an alternative manufacturing process.
Zoster Vaccine, Live has completed Phase 3 clinical development. Four trials are recorded for this vaccine, all of which are completed, including three Phase 3 studies and one Phase 2 study. The trials together enrolled 22,439 participants across the development program.
Zoster Vaccine, Live has been studied in completed trials including NCT01505647, which evaluated a version made with an alternative manufacturing process, and NCT01245751, which assessed a booster dose. Other completed trials include NCT00546819 in patients on chronic corticosteroids and NCT00535730, which tested concomitant administration with PNEUMOVAX 23.
Zoster Vaccine, Live is a live attenuated vaccine designed to induce an immune response against varicella-zoster virus, the pathogen that causes herpes zoster and varicella virus infection. By stimulating immunity to the virus, the vaccine aims to prevent reactivation of latent varicella-zoster virus and the resulting shingles episodes.