Phase 4
Completed N=78
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
Source: ClinicalTrials.gov NCT00289757 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 593.6; 297.4; 363.2; 287.7 mIU/mL
Summary
The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
23; 702; 836; 24; 6107; 5939 | — |
| PRIMARY Number of Seropositive Subjects for Anti-HAV Antibodies. |
43; 46; 42; 50; 46; 41 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE) |
1; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who had received at least one dose of the study vaccine in the primary study
- Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.
Data sourced from ClinicalTrials.gov (NCT00289757). 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.