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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) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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