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Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)

NCT00092417 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 695

Last updated 2015-10-07

Study results available
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Summary

This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Comparator: Varicella Zoster Virus Vaccine

Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (\~207,000 plaque-forming units \[PFU\]/0.65-mL dose)

BIOLOGICAL

Comparator: Varicella Zoster Virus Vaccine

Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (\~58,000 plaque-forming units \[PFU\]/0.65-mL dose)

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2004-06-30
Completion
2004-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00092417 on ClinicalTrials.gov