Prevenar 13 Dosage/Direction for Use

The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
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, adolescents and adults.
Posology: Data on the interchangeability of Prevenar (7 valent) or Prevenar 13 with other pneumococcal conjugate vaccines containing a protein carrier different from CRM₁₉₇ are not available. It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.
Infants aged 2-6 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 11-15 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 considered. The first dose may be given from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended between 11-15 months of age (see Pharmacology: Pharmacodynamics under Actions).
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 Precautions and Pharmacology: Pharmacodynamics under Actions).
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 Pharmacology: Pharmacodynamics under Actions).
Children and adolescents aged 2 years to 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 (7-valent), using the same carrier protein CRM₁₉₇.
Infants and children who have begun immunisation with Prevenar (7-valent) may switch to Prevenar 13 at any point in the schedule. In clinical trials, immunogenicity and safety profiles were comparable.
Young children (12-59 months) completely immunized 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 Pharmacology: Pharmacodynamics under Actions).
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 (7-valent). This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see Pharmacology: Pharmacodynamics under Actions).
Adults aged 18 years and older: Prevenar 13 is to be administered as a single dose to adults 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine.
The need for re-vaccination 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 Interactions and Pharmacology: Pharmacodynamics under Actions).
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 (PPSV23) may receive at least one dose of Prevenar 13 (see Pharmacology: Pharmacodynamics under Actions).
In individuals with a 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 Pharmacology: Pharmacodynamics under Actions).