Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

NCT00343915 | Completed Phase 3 Results

• 5 other identifiers: 101695 Ext. Mth301016961016971016982015-001531-20
• Study Type: interventional
• Target: 267
• Locations: 3 countries
• Sites: 4

Brief Summary

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the time of the primary vaccination course. At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Hepatitis B

Keywords

Persistence; Hepatitis B vaccine

Outcome Measures

Primary Outcomes (3)

• Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  At Month 7

• Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.

  A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  At Month 30, Month 42, Month 54 and Month 66

• Antibody Titers Against Hepatitis-B Virus.

  Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.

  At Month 30, Month 42, Month 54 and Month 66

Secondary Outcomes (7)

• Antibody Titers Against Hepatitis-B Virus.

  At Months 1, 2, 6 and 7

• Number of Subjects Seroprotected for Anti-HBs Antibody.

  At Months 1, 2 and 6

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Day 0-3) follow-up period after each vaccination and overall

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

  During the 4-day (Day 0-3) follow-up period after each vaccination and overall

• Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).

  During the 31-day (Day 0-30) follow-up period after each vaccination and overall

Study Arms (2)

2-Dose Engerix

EXPERIMENTAL

subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.

Biological: Engerix™-B (thiomersal-free) 20µg; Biological: placebo

3-Dose Engerix

ACTIVE COMPARATOR

subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.

Biological: 10 μg Engerix™-B (preservative-free)

Interventions

Engerix™-B (thiomersal-free) 20µg BIOLOGICAL

In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

2-Dose Engerix

10 μg Engerix™-B (preservative-free) BIOLOGICAL

In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

3-Dose Engerix

placebo BIOLOGICAL

In the primary study: 1 deep intramuscular injection (month 1)

2-Dose Engerix

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects have participated in primary study HBV-280
• Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Sydney, New South Wales, Australia

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

GSK Investigational Site

Kyiv, 03038, Ukraine

Location

Related Publications (3)

• Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, Hoet B, Stoffel M. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007 Apr 12;25(15):2817-22. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29.

  PMID: 17276552 BACKGROUND

• Heron LG, Chant KG, Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 2002 Oct 4;20(29-30):3472-6. doi: 10.1016/s0264-410x(02)00346-8.

  PMID: 12297392 BACKGROUND

• Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357.

  PMID: 21171982 BACKGROUND

Related 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.

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: June 23, 2006
• Study Start: April 21, 2004
• Primary Completion: January 10, 2008
• Study Completion: January 10, 2008
• Last Updated: June 10, 2019
• Results First Posted: March 31, 2009

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); UA (1); AU (1)