A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.

Official Title
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A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: ZOSTAVAX™ (concomitant)
* Biological: Comparator: Influenza Vaccine
* Biological: ZOSTAVAX™ (Nonconcomitant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 50 years of age or older Exclusion Criteria: Prior history of Herpes Zoster (shingles) Prior receipt of varicella or zoster vaccine Immunosuppressed

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant<br>Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4 | Biological: ZOSTAVAX™ (concomitant)<br>* a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4<br>* Other names: V211;Biological: Comparator: Influenza Vaccine<br>* a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1<br>* Other names: Fluzone, Vaxigrip;|
| Experimental: Nonconcomitant<br>Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4 | Biological: Comparator: Influenza Vaccine<br>* a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1<br>* Other names: Fluzone, Vaxigrip;Biological: ZOSTAVAX™ (Nonconcomitant)<br>* Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Herpes Zoster