Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

Hepatitis B Clinical Trial

Official title:

Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696917
• Other study ID #: 208129/031
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2008
• Last updated: June 11, 2008
• Start date: April 1999

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.

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: 1303
• Est. primary completion date: February 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• A male or female aged = 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects = 18 years will be enrolled.

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

• Written informed consent obtained from the subject and/or from the parent or guardian of the subject.

• If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

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.

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

• Previous vaccination against hepatitis B.

• History of non-response to previous hepatitis B vaccination.

• Known exposure to hepatitis B within the past 6 weeks.

• History of hepatitis B infection.

• Confirmed human immunodeficiency virus (HIV) infection.

• A family history of congenital or hereditary immunodeficiency.

• 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.

• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.

• Pregnant or lactating female

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• HBV-MPL vaccine 208129
2-dose intramuscular injection 3 different vaccine lots
• Engerix™-B
3-dose intramuscular injection

Locations

Country	Name	City	State
Australia	GSK Clinical Trials Call Center	Parkville	Victoria
Czech Republic	GSK Clinical Trials Call Center	Hradec Kralové
Germany	GSK Clinical Trials Call Center	München
Italy	GSK Clinical Trials Call Center	Bari
Netherlands	GSK Clinical Trials Call Center	Utrecht
Switzerland	GSK Clinical Trials Call Center	Lausanne
United Kingdom	GSK Clinical Trials Call Center	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Czech Republic,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms		Full course of vaccination
Primary	Incidence of serious adverse events		Study period
Primary	Anti-HBs antibody concentrations		At Month 7
Secondary	Occurrence and intensity of solicited local signs and symptoms		4-day after vaccination
Secondary	Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms		4-day after vaccination
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms		30 days after vaccination
Secondary	Occurrence and relationship to vaccination of SAEs		During the study period
Secondary	Anti-HBs antibody concentrations		At Months 1, 2, 6 and 7