Posology : מינונים

4.2     Posology and method of administration

Posology
Prevenar 20 should be used in accordance with official recommendations.

See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.

Paediatric population
The safety and efficacy of Prevenar 20 in infants below 6 weeks of age have not been established. No data are available.

No or only limited data are available for Prevenar 20 in preterm, older unvaccinated, or partially vaccinated infants and children (see sections 4.4, 4.8 and 5.1). The following dosing recommendations are predominantly based on experience with Prevenar 13.

Infants and children 6 weeks to less than 5 years of age

It is recommended that infants who receive a first dose of Prevenar 20 complete the vaccination course with Prevenar 20.

Vaccination schedule in infants and children 6 weeks to 15 months of age 3-dose series (two-dose The recommended immunisation series for Prevenar 20 given as part of a primary series followed routine infant immunisation program, consists of three doses, each of 0.5 mL.
by a booster dose)         The first dose is usually given at 2 months of age, with a second dose 2 months later. The first dose may be given as early as 6 weeks of age. The third (booster) dose is recommended between 11 and 15 months of age (see section 5.1).

4-dose series (three-dose Prevenar 20 may be given as a 4-dose series, each of 0.5 mL. The primary primary series followed infant series consists of three doses, with the first dose usually given at by a booster dose)        2 months of age and with an interval of at least 4 weeks between doses. The first dose may be given as early as 6 weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age (see section 5.1).

Preterm infants (less than The recommended immunisation series for Prevenar 20 consists of four 37 weeks of gestation)a    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 4 weeks between doses. The first dose may be given as early as 6 weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age (see sections 4.4 and 5.1).

Vaccination schedule for infants and children less than 15 months of age transitioning from another pneumococcal conjugate vaccineb
Prior vaccination with Infants and children who have begun immunisation with another another    pneumococcal pneumococcal conjugate vaccine may complete immunisation by conjugate vaccine          transitioning to Prevenar 20 at any point in the schedule.

Catch-up vaccination schedule for infants and children 7 months to less than 18 years of age 


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Unvaccinated infants 7 to Two doses, each of 0.5 mL, with an interval of at least 4 weeks between less than 12 months of doses. A third dose is recommended in the second year of life.
agea


Unvaccinated children 12 Two doses, each of 0.5 mL, with an interval of at least 8 weeks between to less than 24 months of doses.
agea

Unvaccinated children 2 One single dose of 0.5 mL.
to less than 5 years of agea

Children 15 months to 1 dose (0.5 mL).
less than 5 years of age previously    vaccinated If a previous pneumococcal conjugate vaccine was administered, at least 8 with a pneumococcal weeks should elapse before administering Prevenar 20 (see section 5.1).
conjugate vaccine

Children 5 to less than 1 dose (0.5 mL).
18 years of age regardless of prior pneumococcal If a previous pneumococcal conjugate vaccine was administered, at least conjugate vaccination      8 weeks should elapse before administering Prevenar 20 (see section 5.1).
 a. In preterm and unvaccinated infants and children 7 months to less than 5 years of age, Prevenar 20 is expected to perform similarly to Prevenar 13, a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Prevenar 20.
 b. The safety and immunogenicity of Prevenar 20 administered to infants and children less than 15 months of age who have begun vaccination with another pneumococcal conjugate vaccine have not been established. However, safety and immunogenicity studies with a transition from a lower valent to higher valent pneumococcal conjugate vaccine are relevant to Prevenar 20.
Based on clinical experience and relevant randomised controlled trials, the recommended transition from a lower to a higher valent pneumococcal conjugate vaccine may be considered in guiding vaccination with Prevenar 20 for infants and children who have not yet completed the infant vaccination series.


Individuals 18 years of age and older

Prevenar 20 is to be administered as a single dose to individuals 18 years of age and older.

The need for revaccination with a subsequent dose of Prevenar 20 has not been established.
No data on sequential vaccination with other pneumococcal vaccines or a booster dose are available for Prevenar 20. Based on the clinical experience with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Prevenar 20), if the use of 23- valent pneumococcal polysaccharide vaccine (Pneumovax 23 [PPSV23]) is considered appropriate, Prevenar 20 should be given first (see section 5.1).


Special populations
There are no data with Prevenar 20 in special populations.

Experience from clinical studies with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Prevenar 20) are available in children and adults at higher risk of pneumococcal infection including immunocompromised children and adults with human immunodeficiency virus (HIV) infection or haematopoietic stem cell transplant (HSCT), and children with sickle cell disease (SCD) (see sections 4.4 and 5.1).

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Based on these data the following posology was recommended for Prevenar 13: - Individuals at higher risk of pneumococcal infection (e.g., individuals with SCD or HIV infection), including those previously vaccinated with 1 or more doses of PPSV23, were recommended to receive at least 1 dose of Prevenar 13.
- In individuals with a HSCT, the recommended immunisation series with Prevenar 13 consisted of 4 doses of 0.5 mL each. The primary series consisted of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 4 weeks between doses.
A booster dose was recommended 6 months after the third dose (see section 5.1).


The recommended dosing of Prevenar 13 may be considered in guiding vaccination with Prevenar 20 in high-risk populations. For information on responses to pneumococcal vaccines in immunocompromised individuals, please also refer to sections 4.4. and 5.1.

Method of administration

For intramuscular use only.
The vaccine (0.5 mL) 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. Prevenar 20 should be administered, with care to avoid injection into or near nerves and blood vessels.

For instructions on the handling of the vaccine before administration, see section 6.6.