study of the immunogenicity and safety of a decoy dose of HBVAXPRO®, in healthy children vaccinated 10 years ago with 3 doses of HEXAVAC® or INFANRIX®-HEXA.
- Conditions
- HEALTHY CHILDRENTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-001602-28-IT
- Lead Sponsor
- Sanofi Pasteur MSD S.N.C.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects have to meet all the following criteria to be eligible for inclusion:
1.Healthy child of either gender
2.Child vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants (documented vaccination history)
3.Child vaccinated with the third dose of HEXAVAC® or INFANRIX®-HEXA at least 10 years prior to challenge dose
4.Subject and parent(s) or legal representative fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent and assent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 750
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects meeting at least one of the following criteria will be ineligible for inclusion. Please note for criteria marked with an asterisk, a subject can return to be entered into the study once these criteria no longer apply:
1.*History of febrile illness (body temperature =38.0°C) in the 3 days prior to challenge dose
2.Receipt of more than 3 doses of any Hepatitis B containing vaccine either alone or in any combination
3.History of clinical diagnosis of infection due to Hepatitis B
4.History or current close contact with known carriers of Hepatitis B virus
5.Prior known sensitivity or allergy to any component of HBVAXPRO®
6.Known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic systems
7.Severe thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injection
8.Immune impairment or humoral/cellular deficiency or depressed immunity
9.Subject is pregnant (as determined by a urine pregnancy test provided by the sponsor)
10.*High dose systemic corticosteroids (i.e. = 1 mg/day/kg prednisone equivalent administered orally or parenterally) given =14 days in the 30 days prior to challenge dose. Inhaled, nasal or topical corticosteroids are not considered as systemic treatment
11.Immunoglobulins, blood or blood-derived products in the 3 months prior to challenge dose
12.*Inactivated vaccine in the 14 days prior to challenge dose
13.*Live vaccine in the 28 days prior to challenge dose
14.Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
15.Subject that, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements
16.Planned participation in another clinical study during the present study period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method