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

Henogen

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: Adjuvanted Hep B vaccine Lot 3

Biological: Adjuvanted Hepatitis B vaccine Lot 2

Biological: Adjuvanted Hepatitis B vaccine Lot 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00480116

HN016/HBV-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

450 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.