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
Launched by SANOFI PASTEUR, A SANOFI COMPANY · Dec 11, 2013
Trial Information
Current as of June 04, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
About Sanofi Pasteur, A Sanofi Company
Sanofi Pasteur, a subsidiary of Sanofi, is a global leader in the development and production of vaccines. With a rich heritage in vaccine innovation, the company is dedicated to advancing public health by providing safe, effective, and accessible immunizations for a wide range of infectious diseases. Sanofi Pasteur invests significantly in research and development to address evolving health challenges and to enhance vaccine coverage worldwide. Committed to collaboration with health organizations and communities, the company strives to protect individuals and populations through its comprehensive portfolio of vaccines, contributing to the prevention of diseases and the promotion of healthier lives globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, , Italy
Cagliari, , Italy
Capannori, , Italy
Chiavari, , Italy
Latisana, , Italy
Massafra, , Italy
Nocera Inferiore, , Italy
Ragusa, , Italy
Salerno, , Italy
Sassari, , Italy
Patients applied
Trial Officials
Medical Director
Study Director
Sanofi Pasteur, a Sanofi Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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