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Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule

NCT00480116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2008-08-25

No results posted yet for this study

Summary

The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.

Conditions

Interventions

BIOLOGICAL

Adjuvanted Hepatitis B vaccine Lot 1

20 µg, IM, month 0 and 1

BIOLOGICAL

Adjuvanted Hepatitis B vaccine Lot 2

20µg, IM, month 0 and 1

BIOLOGICAL

Adjuvanted Hep B vaccine Lot 3

20µg, IM, month 0 and 1

Sponsors & Collaborators

  • Henogen

    lead INDUSTRY

Principal Investigators

  • Jiri Beran, MD · Vaccination and Travel Medicine Centre Poliklinika II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

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 NCT00480116 on ClinicalTrials.gov