NCT00693186

A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

Summary

Primary objective: * To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg . Secondary objectives: * Additional immunogenicity assessments * Standard safety assessment.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HBVaxPRO® 5 µg / 0.5 mL	5 µg / 0.5 mL
BIOLOGICAL	Engerix B® 10 µg / 0.5 mL	10 µg

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2008-06-06
• Last updated: 2017-09-11

Locations

5 sites across 1 country: Italy