A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
Phase 3
Completed
- Conditions
- Herpes Zoster
- Interventions
- Biological: ZOSTAVAX™ (concomitant)Biological: ZOSTAVAX™ (Nonconcomitant)
- Registration Number
- NCT00231816
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 763
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Concomitant ZOSTAVAX™ (concomitant) Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4 Nonconcomitant ZOSTAVAX™ (Nonconcomitant) Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4
- Primary Outcome Measures
Name Time Method Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses 4 weeks 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.
- Secondary Outcome Measures
Name Time Method