Approval Probability
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Adjusted LOA
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ZOSTAVAX · 4 trials · 2 indications
Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.
Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.
Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).
The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.
| Arm | Type | Description |
|---|---|---|
| Concomitant Vaccination | EXPERIMENTAL | ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4 |
| Nonconcomitant Vaccination | EXPERIMENTAL | Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4 |
| ZOSTAVAX intramuscular (IM) route | EXPERIMENTAL | Single dose of 0.65 mL via IM injection |
| ZOSTAVAX subcutaneous (SC) route | ACTIVE_COMPARATOR | Single dose of 0.65 mL via SC injection |
| Single Dose of Zostavax | EXPERIMENTAL | Zostavax 0.65mL intramuscular injection administered on Day 0 |
| Zostavax - Day 0 and Month 1 | EXPERIMENTAL | Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1 |
| Zostavax - Day 0 and Month 3 | EXPERIMENTAL | Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3 |
| Concomitant | EXPERIMENTAL | Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4 |
| Nonconcomitant | EXPERIMENTAL | Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4 |
| Name | Type | Description |
|---|---|---|
| ZOSTAVAX™ | BIOLOGICAL | A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant) |
| Placebo to ZOSTAVAX™ | BIOLOGICAL | A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant) |
| Influenza Vaccine | BIOLOGICAL | A single open-label administration of 0.5 mL intramuscular injection on Day 1 |
| ZOSTAVAX | BIOLOGICAL | 1 dose 0.65 mL |
| ZOSTAVAX™ (concomitant) | BIOLOGICAL | a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4 |
| Comparator: Influenza Vaccine | BIOLOGICAL | a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1 |
| ZOSTAVAX™ (Nonconcomitant) | BIOLOGICAL | Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4 |
Inclusion Criteria: * Has history of varicella or residence in a VZV-endemic area for ≥30 years * Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study Exclusion Criteria: * H...
ZOSTAVAX is a vaccine used for the prevention of herpes zoster, also known as shingles. It is indicated for the prevention of herpes zoster in adults. The vaccine is being studied in clinical trials for this purpose.
ZOSTAVAX is developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. Merck is the company responsible for the development and clinical trials of this vaccine.
ZOSTAVAX is in Phase 3 clinical development. All three completed trials for ZOSTAVAX are Phase 3 trials. The vaccine is investigational and not yet approved by regulatory authorities.
ZOSTAVAX has been studied in three completed Phase 3 trials: NCT00231816, NCT00561080, and NCT01391546. These trials evaluated the vaccine's immunogenicity and safety in adults aged 50 years and older, including those with a history of chickenpox.
ZOSTAVAX is a vaccine designed to prevent herpes zoster. It works by stimulating the immune system to produce a protective response against the varicella-zoster virus, which causes shingles. The vaccine is administered to elicit immunity and reduce the risk of developing herpes zoster.