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 (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: Comparator: Influenza Vaccine; Biological: ZOSTAVAX™ (Nonconcomitant); Biological: ZOSTAVAX™ (concomitant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231816

V211-011

2005_036

Details and patient eligibility

About

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.

Enrollment: 763 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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763 participants in 2 patient groups

Concomitant

Experimental group

Description:

Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4

Treatment:

Biological: ZOSTAVAX™ (concomitant)

Biological: Comparator: Influenza Vaccine

Nonconcomitant

Experimental group

Description:

Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4

Treatment:

Biological: ZOSTAVAX™ (Nonconcomitant)

Biological: Comparator: Influenza Vaccine