NCT01405677

Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine

A Phase II Open, Randomised, Controlled Study to Evaluate the Safety and Immunogenicity of a Paediatric Dose (0.25 mL) and the Standard Dose (0.5 mL) of Epaxal® With Reference to Havrix Junior® Healthy in Healthy Children and Adolescents (>=12 Months - 16 Years of Age) Using a 0/6 Month Schedule

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 12 Months – 16 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Epaxal 0.25 mL	12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)
BIOLOGICAL	Epaxal 0.5 mL	24 IU hepatitis A antigen coupled to IRIV
BIOLOGICAL	Havrix Junior 0.5 mL	720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Timeline

• Start date: 2004-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-07-29
• Last updated: 2014-07-29

Locations

2 sites across 1 country: Belgium