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A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

NCT01385566 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2016-06-23

Study results available
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Summary

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous

One 0.65 mL injection subcutaneously on Day 1

BIOLOGICAL

ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous

One approximately 0.22 mL injection subcutaneously on Day 1

BIOLOGICAL

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal

Two intradermal injections of approximately 0.15 mL each on Day 1

BIOLOGICAL

ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal

One intradermal injection of approximately 0.1 mL on Day 1

BIOLOGICAL

Full Dose Intradermal Placebo

Two intradermal placebo injections of approximately 0.15 mL each on Day 1

BIOLOGICAL

Intradermal Placebo

One intradermal placebo injection of approximately 0.1 mL on Day 1

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

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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 NCT01385566 on ClinicalTrials.gov