Posology : מינונים

4.2     Posology and method of administration

The immunisation schedules for Prevenar 13 should be based on official recommendations.
Posology

Infants and children aged 6 weeks to 5 years

It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.

Infants aged 6 weeks-6 months

Three-dose primary series
The recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.

Two-dose primary series
Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml, may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended between 11 and 15 months of age (see section 5.1).

Preterm infants (<37 weeks gestation)

In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age.
The fourth (booster) dose is recommended between 11 and 15 months of age (see sections 4.4 and 5.1).

Unvaccinated infants and children ≥ 7 months of age

Infants aged 7-11 months
Two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.

Children aged 12-23 months
Two doses, each of 0.5 ml, with an interval of at least 2 months between doses (see section 5.1).

Children and adolescents aged 2-17 years
One single dose of 0.5 ml.
Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) Prevenar 13 contains the same 7 serotypes included in Prevenar, using the same carrier protein CRM197.

Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule.


Young Children (12-59 months) completely immunised with Prevenar (7-valent) Young children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of Prevenar 13 to elicit immune responses to the 6 additional serotypes. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see section 5.1).

Children and adolescents 5–17 years
Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see section 5.1).

Adults ≥18 years of age, and the elderly

One single dose.
The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
Regardless of prior pneumococcal vaccination status, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first (see sections 4.5 and 5.1).

Special Populations

Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of Prevenar 13 (see section 5.1).

In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of four doses of Prevenar 13, each of 0.5 ml. The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A fourth (booster) dose is recommended 6 months after the third dose (see section 5.1).

Method of administration

The vaccine should be given by intramuscular injection. The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults.