NCT02526745

Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged 50 years and older. Half of participants will receive high doses of the vaccine,while the other half will receive low doses of the vaccine in phase I clinical trial. At the phase II clinical trial, participants will be distributed equally to four groups(low、middle, high doses of the vaccine and placebo).

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	the vaccine with high doses of virus content between 4.7～5.0 lgPFU
BIOLOGICAL	the vaccine with low doses of virus content between 4.7～5.0 lgPFU
BIOLOGICAL	the vaccine with high doses of virus content between 4.3～5.0 lgPFU
BIOLOGICAL	the vaccine with middle doses of virus content between 4.3～5.0 lgPFU
BIOLOGICAL	the vaccine with low doses of virus content between 4.3～5.0 lgPFU
BIOLOGICAL	placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-07-01
• First posted: 2015-08-18
• Last updated: 2016-08-15