Phase 3
Completed N=51
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
Source: ClinicalTrials.gov NCT00289718 ↗Enrolled (actual)
51
Serious AEs
100.0%
Results posted
Aug 2010
Primary outcomePrimary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 369.1; 323.5; 293.7; 298.2 mIU/mL
Summary
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 15.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
369.1; 323.5; 293.7; 298.2; 274.4 | — |
| PRIMARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. |
1; 0; 0 | — |
| PRIMARY Number of Subjects Seropositive for Anti-HAV Antibodies |
33; 33; 32; 30; 29 | — |
| PRIMARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration |
9.7; NA; 9.5; 15022.3 | — |
| PRIMARY Number of Subjects Seropositive for Anti-HB Antibodies |
33; 33; 32; 29; 27; 28 | — |
| PRIMARY Number of Subjects Seroprotected for Anti-HBs Antibodies. |
33; 32; 32; 29; 27; 28 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAE) |
0; 1 | — |
| PRIMARY Number of Subjects Reporting Any Solicited General Symptoms. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AE) |
1 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
- Written informed consent will be obtained from each subject before the blood sampling visit of each year
Data sourced from ClinicalTrials.gov (NCT00289718). 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.