Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA

Hepatitis B Clinical Trial

Official title:

An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012998
• Other study ID #: HXV02C
• Secondary ID: 2013-001602-28
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2013
• Last updated: September 8, 2017
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 751
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

Inclusion Criteria:

• Healthy child

• Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant

• Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose

Exclusion Criteria:

• Receipt of more than 3 doses of any Hepatitis B containing vaccine

• History of clinical diagnosis of infection due to Hepatitis B

• History or current close contact with known carriers of Hepatitis B virus

• Prior known sensitivity or allergy to any component of HBVAXPRO

• Chronic illness / medical condition that could interfere with study conduct or completion

• Coagulation disorder that would contraindicate intramuscular injection

• Subject is pregnant

• Receipt of corticosteroids for more than 14 days in the 30 days prior to study

• Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study

• Planned participation in another clinical study

Related Conditions & MeSH terms

• Hepatitis B
• Virus Diseases

Intervention

Biological:
• HBVAXPRO 5µg
0.5mL intramuscular injection

Locations

Country	Name	City	State
Italy	Sanofi Pasteur MSD Investigational Site 004	Bologna
Italy	Sanofi Pasteur MSD Investigational Site 009	Cagliari
Italy	Sanofi Pasteur MSD Investigational Site 005	Capannori
Italy	Sanofi Pasteur MSD Investigational Site 003	Chiavari
Italy	Sanofi Pasteur MSD Investigational Site 002	Latisana
Italy	Sanofi Pasteur MSD Investigational Site 008	Massafra
Italy	Sanofi Pasteur MSD Investigational Site 006	Nocera Inferiore
Italy	Sanofi Pasteur MSD Investigational Site 010	Ragusa
Italy	Sanofi Pasteur MSD Investigational Site 007	Salerno
Italy	Sanofi Pasteur MSD Investigational Site 001	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with an anti-hepatitis B concentration =10 mIU/mL		One month after the challenge dose
Secondary	Percentage of subjects with an anti-hepatitis B concentration =10 mIU/mL		Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Secondary	Solicited injection-site adverse reactions and pyrexia		Day 0 to day 4 after vaccination
Secondary	Unsolicited injection-site adverse reactions and systemic adverse events		Day 0 to day 14 after vaccination
Secondary	Serious adverse events		From signature of the informed consent to the last visit of the subject, an expected average of one month