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

NCT ID: NCT00480116

Last Updated: 2008-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.

Conditions

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Hepatitis B

Keywords

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Consistency Immunogenicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Adjuvanted Hepatitis B vaccine Lot 1

Intervention Type BIOLOGICAL

20 µg, IM, month 0 and 1

2

Group Type ACTIVE_COMPARATOR

Adjuvanted Hepatitis B vaccine Lot 2

Intervention Type BIOLOGICAL

20µg, IM, month 0 and 1

3

Group Type ACTIVE_COMPARATOR

Adjuvanted Hep B vaccine Lot 3

Intervention Type BIOLOGICAL

20µg, IM, month 0 and 1

Interventions

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Adjuvanted Hepatitis B vaccine Lot 1

20 µg, IM, month 0 and 1

Intervention Type BIOLOGICAL

Adjuvanted Hepatitis B vaccine Lot 2

20µg, IM, month 0 and 1

Intervention Type BIOLOGICAL

Adjuvanted Hep B vaccine Lot 3

20µg, IM, month 0 and 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A healthy male or female adult aged between 18 and 40 years.
* Written informed consent obtained from the subject

Exclusion Criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
* Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 months.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Henogen

Principal Investigators

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Jiri Beran, MD

Role: PRINCIPAL_INVESTIGATOR

Vaccination and Travel Medicine Centre Poliklinika II

Locations

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Vaccination and Travel Medicine Centre Poliklinika II

Hradec Králové, , Czechia

Site Status

Countries

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Czechia

References

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Beran J, Hobzova L, Wertzova V, Kuriyakose S, Leyssen M, Surquin M, Houard S. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Hum Vaccin. 2010 Jul;6(7):578-84. doi: 10.4161/hv.6.7.11883. Epub 2010 Jul 1.

Reference Type DERIVED
PMID: 20523113 (View on PubMed)

Other Identifiers

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HN016/HBV-002

Identifier Type: -

Identifier Source: org_study_id