Trial | NCT00480116  Report issue

Title

Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule
Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hepatitis b vaccine (recombinant) ...

  • Study Participants

    450
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.
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.
Study Started
Jan 31
2008
Primary Completion
Apr 30
2008
Study Completion
Apr 30
2008
Last Update
Aug 25
2008
Estimate

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

1 Active Comparator

2 Active Comparator

3 Active Comparator

Criteria 

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.
No Results Posted