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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02519855 | Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) | PHASE3 | COMPLETED | 882 | — | — | Sep 11, 2015 | Jan 26, 2016 | Oct 30, 2018 | - | — |
| NCT01391546 | Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045) | PHASE3 | COMPLETED | 354 | — | — | Jun 20, 2011 | Oct 15, 2012 | Jan 9, 2019 | - | — |
| NCT00231816 | A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011) | PHASE3 | COMPLETED | 763 | — | — | Sep 1, 2005 | Mar 1, 2006 | Sep 21, 2015 | - | — |
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
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 |
| 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...