Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

Hepatitis B Clinical Trial

Official title:

Evaluating the Consistency of 3 Consecutive Lots of GSK Biologicals' Novel Adjuvanted HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as a Control, Administered According to a 0, 1, 2-month Schedule in Healthy Volunteers (15-50y).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697866
• Other study ID #: 208129/037
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: September 15, 2016
• Start date: August 2000

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthBelgium: Institutional Review BoardUnited Kingdom: National Health ServiceCzech Republic: Ethics CommitteeItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.

Description:

Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.

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: 951
• Est. primary completion date: February 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.

• Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable

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

• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days 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) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).

• Previous vaccination against hepatitis B

• History of non-response to previous hepatitis B vaccination

• Known exposure to hepatitis B within the previous 6 weeks

• History of hepatitis B infection

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

• A family history of congenital or hereditary immunodeficiency.

• Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)

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

• Acute disease at the time of enrolment.

• 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 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 B

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs antibody concentrations		At month 3
Secondary	Anti-HBs antibody concentrations		At M1, M2, M3
Secondary	Anti-RF1 antibody titres in a subset of 50 subjects per group		At months 0 and 3
Secondary	Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms		During a 4-day follow-up after vaccination
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited symptoms		Within 30 days after each vaccination
Secondary	Occurrence, intensity and relationship to vaccination of serious adverse events		During the study period

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.