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Also known as ZOSTAVAX™ (concomitant), V211, Zoster vaccine live, zoster vaccine live (ZOSTAVAX™)
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 used for the prevention of herpes zoster, also known as shingles. It is an investigational vaccine being studied in adults aged 50 years and older to reduce the risk of developing this viral infection.
ZOSTAVAX is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the vaccine's safety and effectiveness in preventing herpes zoster.
ZOSTAVAX is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. All completed trials for ZOSTAVAX are Phase 3 studies, with no active trials currently ongoing.
ZOSTAVAX has completed three Phase 3 clinical trials: NCT00231816, NCT00561080, and NCT01391546. These studies evaluated the vaccine in adults aged 50 years and older, including those with a history of chickenpox, and assessed immunogenicity and safety.
ZOSTAVAX is a vaccine designed to prevent herpes zoster by stimulating the immune system to produce a protective response against the varicella-zoster virus. It is administered to individuals aged 50 years and older to reduce the risk of developing shingles.