Table 1.
Composition of the newly introduced DTaP-IPV-Hib-HepB vaccine (Hexaxim, Sanofi Pasteur, Lyon, France) vs. DTaP-IPV/Hib (Pentaxim, Sanofi Pasteur) [7,33]
| Ingredient | Concentration per 0.5-mL dose |
Function | |
|---|---|---|---|
| DTaP-IPV-Hib-HepB (Hexaxim) | DTaP-IPV/Hib (Pentaxim) | ||
| Diphtheria toxoid | 30 Lf (≥20 IUa)) | 30 Lf (≥20 IUa)) | Active ingredient |
| Tetanus toxoid | 10 Lf (≥40 IUa)) | 10 Lf (≥40 IUa)) | Active ingredient |
| Bordetella pertussis antigens | Active ingredient | ||
| Pertussis toxoid | 25 µg | 25 µg | |
| Filamentous hemagglutinin | 25 µg | 25 µg | |
| Polio virus (Mahoney) type 1b) | 40 D-antigen units | 32 D-antigen units | Active ingredient |
| Polio virus (MEF-1) type 2b) | 8 D-antigen units | 8 D-antigen units | |
| Polio virus (Saukett) type 3b) | 40 D-antigen units | 32 D-antigen units | |
| Haemophilus influenza type b polysaccharide (polyribosyl-ribitolphosphate [PRP]) conjugated to tetanus protein (PRP-T) | 12 µg | 10 µg | Active ingredient |
| Hepatitis B surface antigenc) | 10 µg | None | Active ingredient |
| Aluminium hydroxide, hydrated, for adsorption | 0.6 mg Al3+ | 0.3 mg All3+ | Adjuvant |
| Buffer solution | Neutralization, osmolality, and adjustment | ||
| Water for injection | Up to 0.5 mL | Up to 0.5 mL | |
DTaP, diphtheria and tetanus toxoids and acellular pertussis; IPV, inactivated poliovirus; Hib, Haemophilus influenzae type b; HepB, hepatitis B.
a)
As lower confidence limit (P=0.95).
b)
Produced on Vero cells.
c)
Produced in yeast Hansenula polymorpha cells using recombinant DNA technology