NCT01349829

A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Months – 47 Months
• Healthy volunteers: Accepted

Summary

This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	HAVpur Junior	≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months
BIOLOGICAL	Havrix 720 Junior	≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-05-09
• Last updated: 2013-12-17
• Results posted: 2013-12-17

Locations

3 sites across 1 country: India