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

Phase 3

Completed

• Conditions: Hepatitis B; Virus Diseases
• Interventions: Biological: HBVAXPRO 5µg

• Registration Number: NCT02012998
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Study Start: 2014-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HBVAXPRO Challenge dose	HBVAXPRO 5µg	HBVAXPRO 5µg

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL	One month after the challenge dose

Secondary Outcome Measures

Name	Time	Method
Serious adverse events	From signature of the informed consent to the last visit of the subject, an expected average of one month
Solicited injection-site adverse reactions and pyrexia	Day 0 to day 4 after vaccination
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)
Unsolicited injection-site adverse reactions and systemic adverse events	Day 0 to day 14 after vaccination

Trial Locations

Locations (10)

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 010; 🇮🇹 Ragusa, 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 007; 🇮🇹 Salerno, Italy

Sanofi Pasteur MSD Investigational Site 001; 🇮🇹 Sassari, Italy