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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Engerix™-B (thiomersal-free) 20µg; Biological: 10 μg Engerix™-B (preservative-free); Biological: placebo

• Registration Number: NCT00343915
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Study Timeline

• Study Start: 2004-04-21
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-23
• Primary Completion: 2008-01-10
• Study Completion: 2008-01-10
• Results First Submitted: 2008-12-23
• Results First Submitted QC: 2009-03-18
• Results First Posted: 2009-03-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Dose Engerix	Engerix™-B (thiomersal-free) 20µg	subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
2-Dose Engerix	placebo	subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
3-Dose Engerix	10 μg Engerix™-B (preservative-free)	subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.	At Month 30, Month 42, Month 54 and Month 66	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Antibody Titers Against Hepatitis-B Virus.	At Month 30, Month 42, Month 54 and Month 66	Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.

Secondary Outcome Measures

Name	Time	Method
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	Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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	Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) \> 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
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	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Antibody Titers Against Hepatitis-B Virus.	At Months 1, 2, 6 and 7	Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Number of Subjects Seroprotected for Anti-HBs Antibody.	At Months 1, 2 and 6	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Number of Subjects With Serious Adverse Events (SAEs)	During the entire study period (Month 0 to Month 66)	Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects With Serious Adverse Events (SAEs).	At Month 30, Month 42, Month 54 & Month 66	erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇦 Kyiv, Ukraine