Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

NCT00697840 | Completed Phase 3

• 1 other identifier: 208129/019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Conditions

Hepatitis B

Keywords

Hepatitis B; Engerix™-B; Recombinant hepatitis B vaccine; Adjuvant

Outcome Measures

Primary Outcomes (5)

• Anti-HBs antibody concentrations

  At month 7

• Occurrence and intensity of solicited local and general symptoms

  4-day follow-up after vaccination

• Occurrence of unsolicited adverse events

  30-days after vaccination

• Incidence of serious adverse events

  Throughout the study period

• Anti-Hbs antibody concentrations

  Months 1, 6 and 24

Study Arms (3)

Group A

EXPERIMENTAL

Biological: HBV-MPL 208129

Group B

ACTIVE COMPARATOR

Biological: Engerix™-B

Group C

EXPERIMENTAL

Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation

Interventions

Engerix™-B BIOLOGICAL

Intramuscular injection, 2 doses

Group B

HBV-MPL 208129 BIOLOGICAL

Intramuscular injection, 2 doses

Group A

Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation BIOLOGICAL

Intramuscular injection, 2 doses; experimental formulation

Group C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 40 years old.
• Written informed consent will have been obtained from the subjects.
• Good physical condition as established by physical examination and history taking at the time of entry.
• Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

You may not qualify if:

• Pregnancy or lactation.
• Positive titres for anti HBs antibody.
• Any vaccination against hepatitis B in the past.
• Any previous administration of MPL.
• Elevated serum liver enzymes.
• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
• Axillary temperature \> 37.5°C at the time of injection.
• Any acute disease at the moment of entry.
• Chronic alcohol consumption.
• Any treatment with immunosuppressive or immunostimulant therapy.
• History of allergic disease likely to be stimulated by any component of the vaccine.
• Simultaneous administration of any other vaccine(s).
• Administration of any immunoglobulin during the study period.
• Simultaneous participation in any other clinical trial.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Clinical Trials Call Center

Vienna, Austria

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: June 1, 1995
• Primary Completion: January 1, 1996
• Study Completion: January 1, 1996
• Last Updated: June 16, 2008

Record last verified: 2008-06

Locations

AU (1)