Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

Hepatitis B Clinical Trial

Official title:

Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697775
• Other study ID #: 208129/028
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: March 1998

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

Description:

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: May 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Age: between 11 and 15 years at the time of the first vaccination.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

• Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.

• If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

Exclusion Criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.

• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.

• Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.

• Previous vaccination against hepatitis B virus.

• Previous vaccination with vaccine containing MPL.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Acute disease at the time of enrollment.

• Hepatomegaly, right upper quadrant abdominal pain or tenderness.

• Axillary temperature of = 37.5° C.

• Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.

• Pregnant or lactating female.

• History of chronic disease deemed by the investigator to be relevant.

• Positive for anti-HBV antibodies at screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Biological:
• HBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
• HBV-MPL vaccine Formulation B
2-dose intramuscular injection
• Engerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection

Locations

Country	Name	City	State
Germany	GSK Clinical Trials Call Center	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Serious adverse experiences (SAE)		During the study period
Primary	Occurrence, intensity and relationship to vaccination of solicited local and general symptoms		During the 8-day follow-up period after vaccination
Primary	Occurrence, intensity and causal relationship of unsolicited adverse events		31-day follow-up period after vaccination
Secondary	Anti-HBs antibody concentrations		At months 1, 2, 6, and 7
Secondary	Cell mediated immunity		At months 1, 6, and 7