Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00109122

Enrollment

180

Registered

2005-04-25

Start date

2001-11-30

Completion date

2006-07-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shingles

Brief summary

The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Detailed description

The duration of treatment is 12 weeks.

Interventions

BIOLOGICALzoster vaccine live (Oka/Merck)

BIOLOGICALComparator: placebo (unspecified)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Individuals who are at least 60 years of age with a history of varicella (shingles) * Females must have been postmenopausal.

Exclusion criteria

* Subjects who did not previously participate in the main study of this protocol. * Subject had shingles since their 6 month follow-up visit in main phase of study.

Design outcomes

Primary

Measure	Time frame
VZV ELISPOT response ~6 weeks after 1 and 2 doses	6 weeks after 1 and 2 doses

Secondary

Measure	Time frame
To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo	1 through 3 years after vaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026