Phase 3
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
Hepatitis B · Hepatitis A
Bottom Line
View on ClinicalTrials.gov: NCT00197184 ↗Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Anti-hepatitis A (HAV) Antibody Concentrations — 1122.2; 1377.8; 998.6; 1347.1 mIU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Twinrix™ Adult (Biological); Twinrix™ Junior (Biological)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2004
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 | — |
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.
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.