Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1       Pharmacodynamic properties

Pharmaco-therapeutic group: Viral vaccine, ATC code J07BD52

Immune response in children 12 months and older
In clinical studies in children aged from 12 months to 2 years PRIORIX has been demonstrated to be highly immunogenic.

Vaccination with a single dose of PRIORIX induced antibodies against measles in 98.1%, against mumps in 94.4% and against rubella in 100% of previously seronegative vaccinees.

Two years after primary vaccination seroconversion rates were 93.4% for measles, 94.4% for mumps and 100% for rubella.

Although there are no data available concerning the protective efficacy of PRIORIX, immunogenicity is accepted as an indication of protective efficacy. However, some field studies report that the effectiveness against mumps may be lower than the observed seroconversion rates to mumps.

Immune response in children aged 9 to 10 months
A clinical trial enrolled 300 healthy children 9 to 10 months of age at the time of first vaccine dose. Of these 147 subjects received PRIORIX and VARILRIX concomitantly. Seroconversion rates for measles, mumps and rubella were 92.6%, 91.5% and 100%, respectively. The seroconversion rates reported following the second dose given 3 months after the first dose were 100% for measles, 99.2% for mumps and 100% for rubella. Therefore a second dose of PRIORIX should be given within three months to provide optimal immune responses.

Adolescents and adults

The safety and immunogenicity of PRIORIX in adolescents and adults has not been specifically studied in clinical trials.

Intramuscular route of administration
A limited number of subjects received PRIORIX intramuscularly in clinical trials. The seroconversion rates to the three components were comparable to those seen after subcutaneous administration.

Pharmacokinetic Properties

5.2       Pharmacokinetic properties

An evaluation of pharmacokinetics in vaccines is not necessary.