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

NCT01405677 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2014-07-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Pierre van Damme, MD · Universiteit Antwerpen

  • Andre Vertruyen, MD · Sint-Vincentiusziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405677 on ClinicalTrials.gov