Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 267
- Locations
- 4
- Primary Endpoint
- Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
2-Dose Engerix
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Intervention: Engerix™-B (thiomersal-free) 20µg (Biological)
2-Dose Engerix
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Intervention: placebo (Biological)
3-Dose Engerix
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Intervention: 10 μg Engerix™-B (preservative-free) (Biological)
Outcomes
Primary Outcomes
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Time Frame: 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.
Time Frame: At Month 30, Month 42, Month 54 and Month 66
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Time Frame: At Month 7
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Secondary Outcomes
- 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)
- 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 Serious Adverse Events (SAEs)(During the entire study period (Month 0 to Month 66))
- Number of Subjects With Serious Adverse Events (SAEs).(At Month 30, Month 42, Month 54 & Month 66)