The vaccine is indicated for primary and booster vaccination of children against six infectious diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis caused by 3 types of poliovirus (type 1,2 and 3), and invasive infections caused by Haemophilus influenza type b.
Conditions
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants of either gender, 2. 2 month-old infants (aged 57 to 90 days inclusive), 3. Infant born after 36 weeks of pregnancy and with a birth weight = 2.5 kg, 4. Consent form signed by parents or by the legal representative properly informed about the study, 5. Parents / legal representative able to understand the protocol requirements and to fill in the Diary Card. Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1. Severe febrile illness and/or rectal temperature ³ 38.0°C at the time of vaccination, 2. Known history of diphtheria, tetanus, pertussis, H. influenzae type b, poliomyelitis, hepatitis B, 3. Infant known to be already immunised with one or more doses of vaccine against pertussis, tetanus, diphtheria, H. influenzae type b, poliomyelitis or hepatitis B, 4. Infant born from known HBs-Ag positive mother, 5. Known allergy to at least one of the vaccine components, 6. Known immune dysfunction (including subjects with HIV infection, sickle cell disease, asplenia, and other acquired immunodeficiency), 7. Infant who received within the previous 30 days or who will receive during the course of the study, a treatment likely to alter the immune response (any long-term (³ 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses [³ 2mg/kg/day prednisone equivalent or ³ 20mg/day if weight more than 10kg]), 8. Infant who received within the previous 90 days or who will receive during the course of the study immunoglobulin or blood products 9. Infant with severe chronic disease, 10. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, 11. BCG vaccination in the previous 30 days, 12. Infant who, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements, 13. Participation in another clinical study within 30 days before study inclusion and/or during the whole study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To show, that when HEXAVAC® upgraded process is given in a 3-dose primary series at 2, 4 and 6 months of age, followed by a booster dose at 12 months the anti-HBs seroprotection rate one month post-primary series or one month post-booster is non inferior to the rate observed in subjects who receive HEXAVAC® current process in the same schedule. 2. If objective 1 is reached post-primary series, to show, that when HEXAVAC® upgraded process or HEXAVAC® current process is given in a 3-dose primary series at 2, 4 and 6 months of age, the anti-HBs seroprotection rate one month post-primary series is acceptable compared to HEXAVAC® historical data. or If objective 1 is reached post-booster, to show, that when HEXAVAC® upgraded process or HEXAVAC® current process is given in a 3-dose primary series at 2, 4 and 6 months of age followed by a booster dose at 12 months, the anti-HBs seroprotection rate one month post-booster is acceptable compared to HEXAVAC® historical data.;Secondary Objective: Immunogenicity: 1. To show that when given in a 3-dose primary series at 2, 4 and 6 months of age followed by a booster dose at 12 months, the one month post-booster anti-HBs GMT of HEXAVAC® upgraded process is superior to the one month post-booster anti-HBs GMT of HEXAVAC® current process. 2. To describe the one month post-primary series, the pre-booster and the one month post-booster immune responses to all HEXAVAC® upgraded process and HEXAVAC® current process antigens, when HEXAVAC® upgraded process and HEXAVAC® current process are given in a 3-dose primary series at 2, 4 and 6 months of age followed by a booster dose at 12 months. Safety: 3. To describe the safety profile of HEXAVAC® upgraded process and HEXAVAC® current process when both vaccines are given in a 3-dose primary series at 2, 4 and 6 months of age followed by a booster dose at 12 months.;Primary end point(s): The primary criteria defined for immunogenicity will be the following: The 1-month post | — |
Countries
Czech Republic, Slovakia
Outcome results
None listed