NCT00535730

ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

A Phase III Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With PNEUMOVAX™ 23 in Subjects 60 Years of Age and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.

Conditions

• Herpes Zoster
• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™	0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
BIOLOGICAL	Comparator: placebo (concomitant-vaccine matched)	Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
BIOLOGICAL	Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23	Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-09-26
• Last updated: 2017-04-12
• Results posted: 2009-05-13