Phase 3 N=763 Randomized Double-blind Prevention

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

Herpes Zoster

Bottom Line

View on ClinicalTrials.gov: NCT00231816 ↗

Enrolled (actual)

763

Serious AEs

1.5%

Results posted

Dec 2010

Primary outcome: Primary: Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses — 553.5; 588.7 gpELISA units/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ZOSTAVAX™ (concomitant) (Biological); Comparator: Influenza Vaccine (Biological); ZOSTAVAX™ (Nonconcomitant) (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Mar 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses	553.5; 588.7	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00231816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.