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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

NCT02012998

CompletedPhase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Virus Diseases, Hepatitis B

Interventions: HBVAXPRO 5µg

Countries: Italy

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

Eligibility overview

Sex: ALL

Age: 10 Years to 12 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (10)

Bologna, Italy
Cagliari, Italy
Capannori, Italy
Chiavari, Italy
Latisana, Italy
Massafra, Italy
Nocera Inferiore, Italy
Ragusa, Italy
Salerno, Italy
Sassari, Italy