Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Bacterial and viral vaccines combined, ATC code: J07CA06 
Results obtained in the clinical studies for each of the components are summarised in the tables below: 
Percentage of subjects with antibody titres ≥ assay cut-off after primary vaccination with INFANRIX IPV Hib:

3-5       1.5-3.5-6      2-3-4        2-4-6          3-4-5      3-4.5-6 Antibody        months       months       months       months         months      months (cut-off)        N= 86       N= 62        N= 337       N= 624         N= 127       N=198 (1 trial)   (1 trial)    (3 trials)   (6 trials)     (2 trials)   (1 trial) %           %             %            %              %           %
Anti-diphtheria         94.1         100         98.8         99.3           94.4         99.5 (0.1 IU/ml)*
Anti-tetanus           100.0**         100     99.7      99.8        99.2         100 (0.1 IU/ml)*
Anti-PT                 99.5**         100     99.4      100         98.4         100 (5 EL.U/ml)
Anti-FHA                99.7**         100     100       100          100         100 (5 EL.U/ml)
Anti-PRN                99.0**         100     100       100          100         100 (5 EL.U/ml)
Anti-Polio type 1        93.0          ND      99.1      99.5         100         100 (1/8 dilution)*
Anti-Polio type 2        95.3          ND      95.7      99.0        99.2         100 (1/8 dilution)*
Anti-Polio type 3        98.8          ND      100       100         99.2         99.4 (1/8 dilution)*
Anti-PRP (Hib)           83.7          100     98.5      98.5         100         98.4 (0.15 µg/ml)*
Anti-PRP (Hib)           51.2         87.1     68.5      76.0        97.6         81.2 (1.0 µg/ml)
* cut-off accepted as indicative of protection
** Post dose 2 results from studies where DTPa-HBV-IPV+Hib was administered in a schedule 3, 5 and 11 months of age.
N = number of subjects
ND = not determined

Percentage of subjects with antibody titres ≥ assay cut-off after booster vaccination with INFANRIX IPV Hib:

Antibody             Booster vaccination at 11/12      Booster vaccination during (cut-off)            months of age following a 3-        the second year of life 5 months primary course            following a three dose
N =184                        primary course
(1 trial)                   N = 1326 (9 trials)
%                                %
Anti-diphtheria                  100                              99.8 (0.1 IU/ml)*
Anti-tetanus                     99.9**                            99.9 (0.1 IU/ml)*
Anti-PT                          99.9**                            99.7 (5 EL.U/ml)
Anti-FHA                         99.9**                            100 (5 EL.U/ml)
Anti-PRN                         99.5**                            99.9 (5 EL.U/ml)
Anti-Polio type 1                 99.4                             99.9 (1/8 dilution)*
Anti-Polio type 2                   100                      100
(1/8 dilution)*
Anti-Polio type 3                   99.4                     100
(1/8 dilution)*
Anti-PRP (Hib)                      100                      100
(0.15 µg/ml)*
Anti-PRP (Hib)                      96.7                     99.2
(1.0 µg/ml)
* cut-off accepted as indicative of protection
** Post dose 3 results from studies where DTPa-HBV-IPV+Hib was administered in a schedule 3, 5 and 11 months of age.
N = number of subjects

The effectiveness of the Hib component (when combined with DTPa, DTPa-IPV or DTPa-HBV-IPV) was investigated via an extensive post-marketing surveillance study conducted in Germany. Over a 4.5 year follow-up period, the effectiveness of DTPa+Hib or DTPa-IPV+Hib vaccines was 96.7% for a full primary series and 98.5% for a booster dose (irrespective of priming). Over a seven year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines was 89.6% for a full primary series and 100% for a full primary series plus booster dose (irrespective of the Hib vaccine used for priming).

Pharmacokinetic Properties

5.2    Pharmacokinetic properties

Evaluation of pharmacokinetic properties is not required for vaccines.