drugset / Trial / NCT01405677
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).
Timeline
- Start
- 2004-06
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epaxal | Vaccine | 0.25 ml | Intramuscular |
| Subject | Epaxal | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Havrix Junior | Vaccine | 0.5 ml | Intramuscular |