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

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ClinicalTrials.gov Identifier: NCT00480116
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : August 25, 2008
Sponsor:
Information provided by:
Henogen

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Adjuvanted Hepatitis B vaccine Lot 1 Biological: Adjuvanted Hepatitis B vaccine Lot 2 Biological: Adjuvanted Hep B vaccine Lot 3 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2008
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Biological: Adjuvanted Hepatitis B vaccine Lot 1
20 µg, IM, month 0 and 1
Active Comparator: 2 Biological: Adjuvanted Hepatitis B vaccine Lot 2
20µg, IM, month 0 and 1
Active Comparator: 3 Biological: Adjuvanted Hep B vaccine Lot 3
20µg, IM, month 0 and 1



Primary Outcome Measures :
  1. Anti-HBs seroprotection rates at Month 2. [ Time Frame: Month 2 ]

Secondary Outcome Measures :
  1. Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points. [ Time Frame: Month 0, 1 and 2 ]
  2. Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3). [ Time Frame: Month 0 and 1 ]
  3. Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30) [ Time Frame: Month 0 and 1 ]
  4. Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2. [ Time Frame: Month 0 to 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480116


Locations
Czech Republic
Vaccination and Travel Medicine Centre Poliklinika II
Hradec Kralove, Czech Republic, 500 03
Sponsors and Collaborators
Henogen
Investigators
Principal Investigator: Jiri Beran, MD Vaccination and Travel Medicine Centre Poliklinika II

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Houard, Henogen
ClinicalTrials.gov Identifier: NCT00480116     History of Changes
Other Study ID Numbers: HN016/HBV-002
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008

Keywords provided by Henogen:
Consistency
Immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs