Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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).
Condition or disease
Biological: zoster vaccine live (Oka/Merck)Biological: Comparator: placebo (unspecified)
VZV ELISPOT response ~6 weeks after 1 and 2 doses [ Time Frame: 6 weeks after 1 and 2 doses ]
Secondary Outcome Measures :
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 [ Time Frame: 1 through 3 years after vaccination ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Individuals who are at least 60 years of age with a history of varicella (shingles)
Females must have been postmenopausal.
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.