HIBERIX Powder and solvent for solution for injection

Pharmacotherapeutic group: vaccines, Haemophilus influenzae type b, purified antigen conjugated ATC code: J07AG01 Primary vaccination Table 1 shows immunogenicity results from 4 clinical studies in which infants in the United States, Europe, South America, and Southeast Asia received a 3-dose primary vaccination course with Hiberix vaccine within the first 6 months of life, starting from the age of 6 weeks.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Various vaccination schedules were evaluated and Hiberix vaccine was administered concomitantly with other routinely recommended vaccines. Hiberix vaccine was immunogenic in all 3-dose schedules studied. One month after completion of primary immunization, antibody concentrations ≥ 0.15 µg/ml (the level indicating short-term protection) were achieved in 96.6–99.4% of vaccinated children. Table 1: Percentage of subjects with antibody concentrations ≥ 0.15 µg/ml and ≥ 1.0 µg/ml one month after primary vaccination with Hiberix vaccine. Study Age at primary vaccination N Concomitantly administered vaccines % of subjects with antibodies ≥ 0.15 µg/ml (95% CI) % of subjects with antibodies ≥ 1.0 µg/ml (95% CI) Hib-097 months 2-4-6 1 590 DTaP-HBV-IPV PCV13 HRV 96.6 (95.6; 97.4) 81.2 (79.2; 83.1) DTwP-HBV-Hib-008 PRI months 2-4-6 171 DTwP-HBV 99.4 (96.8; 100) 97.7 (94.1; 99.4) DTaP-HBV-IPV-005 months 3-4-5 410 DTaP-HBV-IPV or DTaP-HBV-IPV+OPV (in a 3-dose schedule) 99.0 (97.5; 99.7) 92.7 (89.3; 95.1) – 94.0 (84.7; 98.1)* DTwP-HBV=Hib Kft-001 weeks 6-10-14 175 DTwP-HBV 99.4 (96.9; 100) 96.6 (92.7; 98.7) CI: Confidence interval DTwP-HBV: combined diphtheria, tetanus, pertussis (whole-cell) and hepatitis B vaccine; DTaP-HBV-IPV: combined diphtheria, tetanus, pertussis (acellular), hepatitis B and poliomyelitis vaccine; HRV: human rotavirus vaccine; N: number of subjects in the according-to-protocol (ATP) cohort (except DTwP-HBV-Hib-008: in the total vaccinated cohort) OPV: oral poliomyelitis vaccine; PCV13: pneumococcal 13-valent conjugate vaccine; PRP: Polyribosylribitol phosphate * Pooled analysis data are not available. In addition, in naive toddlers aged 22–26 months (study Hib-036) who received a single dose of Hiberix vaccine concomitantly with DTaP, 100% of subjects [N= 54; 95% CI (93.4; 100)] achieved anti-PRP antibody concentrations > 1.0 µg/ml one month after vaccination. These data support the administration of a single dose of Hiberix vaccine in children from 1 year of age and older. Booster vaccination The antibody response to a booster dose of Hiberix vaccine after a 3-dose primary schedule is shown in Table 2. One month after the booster dose, all children had anti-PRP antibody concentrations > 0.15 µg/ml and at least 99.1% had antibody concentrations > 1.0 µg/ml, a concentration correlating with long-term immunity against Hib (Table 2). Table 2: Percentage of subjects with antibody concentrations ≥ 1.0 µg/ml one month after booster vaccination with Hiberix vaccine. Study N Age at primary vaccination Age at booster vaccination Concomitantly administered vaccines at booster % of subjects with antibodies ≥ 1.0 µg/ml (95% CI) Hib-097 336 months 2-4-6 months 15-18 DTaP 99.1 (97.4; 99.8) DTwP-HBV-Hib-008 BST 161 months 2-4-6 18 months DTwP-HBV 99.4 (96.6; 100) DTwP-HBV=Hib Kft-003 74 weeks 6-10-14 months 15-18 DTwP-HBV 100% (95.1; 100) CI: Confidence interval N: number of subjects in the ATP cohort DTaP: combined diphtheria, tetanus, pertussis (acellular) vaccine DTwP-HBV: combined diphtheria, tetanus, pertussis (whole-cell) and hepatitis B vaccine PRP: Polyribosylribitol phosphate