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Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

NCT02991599 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2021-12-23

Study results available
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Summary

This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in methadone maintenance treatment patients.

Conditions

  • Hepatitis B Vaccine

Interventions

BIOLOGICAL

60 µg dose hepatitis B vaccine

three-dose, 60 µg per dose

BIOLOGICAL

20 µg dose hepatitis B vaccine

three-dose, 20 µg per dose

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • Shanxi Medical University

    lead OTHER

Principal Investigators

  • Suping Wang · Shanxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-07-31
Completion
2018-05-31

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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 NCT02991599 on ClinicalTrials.gov