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PREVNAR® 13 (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. This product should not be used if particulate matter or discoloration is found.

Do not mix Prevnar 13 with other vaccines/products in the same syringe.

2.2 Administration Information

For intramuscular injection only.

Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

2.3 Vaccination Schedule for Infants and Toddlers

Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age.

Table 1: Vaccination Schedule for Infants and Toddlers
Dose Dose 1*, Dose 2 Dose 3 Dose 4
*
Dose 1 may be given as early as 6 weeks of age.
The recommended dosing interval is 4 to 8 weeks.
The fourth dose should be administered at approximately 12–15 months of age, and at least 2 months after the third dose.
Age at Dose 2 months 4 months 6 months 12–15 months

2.4 Vaccination Schedule for Unvaccinated Children 7 Months Through 5 Years of Age

For children 7 months through 5 years of age who have not received Prevnar® or Prevnar 13, the catch-up schedule in Table 2 applies:

Table 2: Vaccination Schedule for Unvaccinated Children 7 Months of Age Through 5 Years of Age
Age at First Dose Total Number of 0.5 mL Doses
*
The first 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months.
Two doses at least 2 months apart.
7–11 months of age 3*
12–23 months of age 2
24 months through 5 years of age (prior to the 6th birthday) 1

The immune responses induced by this catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12–15 months). In children 24 months through 5 years of age, lower antibody concentrations were observed for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months).

2.5 Vaccination Schedule for Children 6 Years Through 17 Years of Age

In children 6 years through 17 years of age, Prevnar 13 is administered as single dose. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.

2.6 Vaccination Schedule for Adults 18 Years of Age and Older

Prevnar 13 is administered as a single dose.

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