NCT01385566

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

A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-06-30
• Last updated: 2016-06-23
• Results posted: 2013-02-21