Hepatitis B Clinical Trial
Official title:
An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA
Verified date | September 2017 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary objective:
- To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA
during the first two years of life the percentage of subjects with an anti-HBs antibody
titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10
µg .
Secondary objectives:
- Additional immunogenicity assessments
- Standard safety assessment.
Status | Completed |
Enrollment | 410 |
Est. completion date | March 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 7 Years |
Eligibility |
Inclusion Criteria: - Healthy child of 4 to 7 years of age of either gender, - Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life, - Informed consent form signed by the parent(s) or by the legal representative. - Parent(s) or legal representative able to understand and comply with the study procedures. Exclusion Criteria: - Any recent (<=3 days) history of febrile illness prior to vaccination, - Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination, - History of clinical or serological-confirmed diagnosis of infection due to hepatitis B, - History or current close contact with known carriers of hepatitis B virus, - Prior known sensitivity/allergy to any component of the study vaccines, - Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems, - Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, - Any immune impairment or humoral/cellular deficiency or depressed immunity, - Any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through Visit 2, - Any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2, - Any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2, - Any recent (<=28 days) receipt of a live vaccine or scheduled administration through Visit 2 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda per i Servizi Sanitari n. 5 "Bassa Friulana" | Latisana | Udine |
Italy | Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore) | Modica | |
Italy | Unità Operativa Semplice di Epidemiologia (UOSE) | Quarto | Napoli |
Italy | AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c | Ragusa | |
Italy | Dipartimento di Prevenzione Servizio di Igiene Pubblica | Sassari |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose | 28 to 42 days |
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