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

NCT02526745 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2016-08-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Beijing Chaoyang District Centre for Disease Control and Prevention

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-07-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526745 on ClinicalTrials.gov