Phase 3
Completed N=178
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Source: ClinicalTrials.gov NCT00289744 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 692.3; 753.6; 544.4; 479.5 milli-international units per milliliter
Summary
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
692.3; 753.6; 544.4; 479.5; 601.6 | — |
| PRIMARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration |
10.4; 8.7; 1431.9; 565.9 | — |
| PRIMARY Number of Subjects With Immune Response to the Additional Dose of Engerix™-B |
19; 6 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Solicited Local and General Symptoms |
6; 3; 2; 1; 1; 0 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events |
1; 1 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
- 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 (NCT00289744). 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.