HEALTHY CHILDREN
Conditions
Interventions
Trade Name: HBVAXPRO®
Pharmaceutical Form: Suspension for injection
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: *To describe, in subjects vaccinated with 3 doses of HEXAVAC® as infants, the percentage of subjects with an anti-HBs concentration =10 mIU/mL one month after a challenge dose of HBVAXPRO® given at least 10 years later *To describe, in subjects vaccinated with 3 doses of INFANRIX®-HEXA as infants, the percentage of subjects with an anti-HBs concentration =10 mIU/mL one month after a challenge dose of HBVAXPRO® given at least 10 years later ;Secondary Objective: Immunogenicity objective: *To describe, in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants, the level of antibody to HBs before and one month after a challenge dose of HBVAXPRO® given at least 10 years later, *To describe, in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants, the level of antibody to HBs before and one month after a challenge dose of HBVAXPRO® given at least 10 years later, by subsets of subjects defined according to the pre-challenge anti-HBs concentration (<10 mIU/mL and =10 mIU/mL). Safety objective: *To describe the safety profile of HBVAXPRO®;Primary end point(s): IMMUNOGENICITY •Percentage of subjects with an anti-HBs concentration =10 mIU/mL before and one month after the challenge dose •GMC before and one month after the challenge dose •GMCR from before to one month after the challenge dose ;Timepoint(s) of evaluation of this end point: ONE MONTH | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SAFETY •From Day 0 to Day 4 percentage of subjects with solicited events: oInjection-site adverse reactions (injection site erythema, injection site swelling and injection site pain), oPyrexia defined as a body temperature =38.0°C •From Day 0 to Day 14 percentage of subjects with: oUnsolicited (i.e. spontaneously reported) injection-site adverse reactions, oUnsolicited (i.e. spontaneously reported) systemic adverse events, •From study vaccination to the last visit: percentage of subjects with serious adverse events ;Timepoint(s) of evaluation of this end point: ONE MONTH | — |
Countries
Italy
Contacts
Public ContactClinical Trial Manager
Sanofi Pasteur MSD SNC
Outcome results
None listed