Phase 4
Completed N=107
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Source: ClinicalTrials.gov NCT00291876 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 748.1; 378.6; 419.3; 342.2 mIU/mL
Summary
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.
No additional subjects will be recruited during this long-term follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
14.9; 15; 26; 14.9; 453; 787 | — |
| PRIMARY Number of Seropositive Subjects Against Hepatitis A Virus |
77; 82; 90; 98; 100; 95 | — |
| SECONDARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration |
14.9; 15; 26; 14.9; 453; 787 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Symptoms |
2; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Solicited General Symptoms |
2; 0; 1; 1; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AE) |
0; 0 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination |
0; 0 | — |
| SECONDARY Number of Subjects Reporting Pregnancies After Additional Vaccination |
0; 0 | — |
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 (NCT00291876). 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.