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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hepatitis B; Virus Diseases

Treatments: Biological: HBVAXPRO 5µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02012998

HXV02C

2013-001602-28 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 751 patients

Sex: All

Ages: 10 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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751 participants in 1 patient group

HBVAXPRO Challenge dose

Experimental group

Description:

HBVAXPRO 5µg

Treatment:

Biological: HBVAXPRO 5µg