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

Merck Sharp & Dohme LLC763 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

763

Conditions

Herpes Zoster

Interventions

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 VaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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