Phase 3
N=882
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)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT02519855 ↗Enrolled (actual)
882
Serious AEs
1.2%
Results posted
Feb 2017
Primary outcome: Primary: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody — 206.0; 230.5; 395.6; 482.0 gpELISA units/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ZOSTAVAX™ (Biological); Placebo to ZOSTAVAX™ (Biological); Influenza Vaccine (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody |
206.0; 230.5; 395.6; 482.0 | <0.001 sig |
| PRIMARY Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers |
1.9; 2.1 | <0.001 sig |
| PRIMARY Geometric Mean Titers of H1N1-specific Influenza Virus Antibody |
51.9; 50.1; 207.3; 200.5 | <0.001 sig |
| PRIMARY Geometric Mean Titers of H3N2-specific Influenza Virus Antibody |
29.5; 31.1; 298.8; 272.0 | <0.001 sig |
| PRIMARY Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody |
14.6; 12.6; 46.7; 43.9 | <0.001 sig |
| PRIMARY Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody |
11.2; 10.4; 33.9; 32.3 | <0.001 sig |
Summary
The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.
Eligibility Criteria
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
- Has history of hypersensitivity to any vaccine component
- Has previously received any varicella or zoster vaccine
- Has received an influenza vaccine for the 2015-16 season
- Has history of Herpes zoster
- Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
- Is pregnant or breastfeeding, or expecting to conceive during the study
- Has used immunosuppressant therapy
- Has known or suspected immune dysfunction
- Has experienced Guillain-Barré syndrome within 6 weeks
- Has severe thrombocytopenia or any other coagulation disorder
Data sourced from ClinicalTrials.gov (NCT02519855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.