Phase 3
Completed N=276
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Source: ClinicalTrials.gov NCT00197184 ↗Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcomePrimary: Anti-hepatitis A (HAV) Antibody Concentrations — 1122.2; 1377.8; 998.6; 1347.1 mIU/mL
Summary
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
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 (HAV) Antibody Concentrations |
1122.2; 1377.8; 998.6; 1347.1; 737.5; 915.9 | — |
| PRIMARY Anti-hepatitis B (HBs) Antibody Concentrations |
479.9; 830.6; 325.1; 695.1; 270.2; 519.7 | — |
| PRIMARY Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. |
— | — |
| PRIMARY Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. |
4.9; 2.4; 521.3; 509.7 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy. |
0; 0 | — |
| SECONDARY Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms |
6; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms. |
3; 0; 0; 0; 3; 0 | — |
| SECONDARY Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs). |
2; 0 | — |
| SECONDARY Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participation in primary study
- Written informed consent obtained before each long term follow up visit.
Data sourced from ClinicalTrials.gov (NCT00197184). 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.