Phase 3
Completed N=384
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Source: ClinicalTrials.gov NCT00343915 ↗Enrolled (actual)
384
Serious AEs
1.3%
Results posted
Mar 2009
Primary outcomePrimary: Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. — 233; 111 Subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. |
122; 62; 139; 74; 124; 72 | — |
| PRIMARY Antibody Titers Against Hepatitis-B Virus. |
28.8; 28.7; 17.6; 29.4; 18.8; 90.0 | — |
| SECONDARY Antibody Titers Against Hepatitis-B Virus. |
28.8; 28.7; 17.6; 29.4; 18.8; 90.0 | — |
| SECONDARY Number of Subjects Seroprotected for Anti-HBs Antibody. |
31; 8; 27; 63; 63; 99 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
121; 44; 6; 3; 30; 10 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
50; 26; 1; 1; 29; 16 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). |
112; 54; 31; 15; 9; 1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
4; 1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs). |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00343915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.