Prevnar 13

Prevnar 13 Dosage/Direction for Use

vaccine, pneumococcal

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Recommended Dose: The immunization schedules for Prevnar 13 should be based on official recommendations.
Data on the interchangeability of pneumococcal 7-valent conjugate vaccine or Prevnar 13 with other pneumococcal conjugate vaccines containing a protein carrier different from CRM197 are not available.
Infants and Children 6 Weeks to 17 Years (Prior to The 18th Birthday): It is recommended that infants who receive a first dose of Prevnar 13 complete the vaccination course with Prevnar 13.
Infants 6 Weeks to 6 Months: Three-Dose Primary Series: The recommended immunization series consists of 4 doses, each of 0.5 mL. The primary infant series consists of 3 doses, each of 0.5 mL, with the 1st dose usually given at 2 months and with an interval of at least 1 month between doses. The 1st dose may be given as early as 6 weeks. A 4th dose is recommended in the 2nd year of life. (See Table 16.)

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Alternatively, when Prevnar 13 is given as part of a routine infant immunization program, a 3-dose schedule may be considered. The 1st dose may be given from the age of 2 months, with a 2nd dose 2 months later, and a 3rd (booster) dose is recommended between 11-15 months (see Pharmacology: Pharmacodynamics under Actions).
Prevnar 13 Schedule for Preterm Infants (<37 Weeks Gestation): In preterm infants, the recommended immunization series consists of 4 doses, each of 0.5 mL. The primary infant series consists of 3 doses, with the 1st dose given at 2 months and with an interval of at least 1 month between doses. The 1st dose may be given as early as 6 weeks. The 4th (booster) dose is recommended at approximately 12 months. For children who are beyond the age of routine infant schedule, the following Prevnar 13 schedule applies. (See Table 17.)

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Prevnar 13 Schedule for Infants and Children Previously Vaccinated with Pneumococcal 7-Valent Conjugate Vaccine (Streptococcus Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F): Prevnar 13 contains the same 7 serotypes contained in pneumococcal 7-valent conjugate vaccine and is manufactured based on the same conjugate technology using the same carrier protein CRM197. Children who have begun immunization with pneumococcal 7-valent conjugate vaccine may complete immunization by switching to Prevnar 13 at any point in the schedule. In clinical trials, immunogenicity and safety profiles were comparable. Children 15 months to 5 years who are considered completely immunized, or with any incomplete pneumococcal 7-valent conjugate vaccine schedule may receive 1 dose of Prevnar 13 to elicit immune responses to the 6 additional serotypes. The catch-up (supplemental) dose of Prevnar 13 should be administered with an interval of at least 8 weeks after the final dose of pneumococcal 7-valent conjugate vaccine. To ensure adequate protection against all 13 serotypes, children 15-23 months that received only a single dose of pneumococcal 7-valent conjugate vaccine before the age of 12 months, should receive 2 doses of Prevnar 13 at least 2 months apart and separated from the 1st dose by at least 2 months.
Prevnar 13 Schedule for Children 12 Months to 5 Years Incompletely Vaccinated with Prevnar 13: For children 7 months to 5 years that have not received any prior doses of Prevnar 13, see the Vaccine Schedule for Previously Unvaccinated Children ≥7 Months to 5 Years (Prior to the 6th Birthday) as previously mentioned.
Children who are considered incompletely vaccinated with Prevnar 13 are children who have received 3 or fewer doses of Prevnar 13 before 12 months and no Prevnar 13 dose after 12 months or children who did not complete the recommended age-appropriate vaccine schedule for previously unvaccinated children (see the Vaccine Schedule for Previously Unvaccinated Children ≥7 Months as previously mentioned).
For children 12 months to 5 years with any incomplete Prevnar 13 schedule, the following schedule applies to complete the Prevnar 13 immunization schedule: See Table 18.

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The immune responses induced by Prevnar 13 schedule may result in lower antibody concentrations compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6 and 12-15 months).
Protective immunity to the 6 new serotypes in Prevnar 13 requires age-appropriate dosing as described previously.
Prevnar 13 Schedule for Children 24 Months to 17 Years: Children 24 months to 5 years and children 6 years to 17 years may receive a single dose of Prevnar 13 whether or not they have been previously vaccinated with ≥1 doses of pneumococcal 7-valent conjugate vaccine. If pneumococcal 7-valent conjugate vaccine was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.
In children 5 to <10 years who received a single dose of Prevnar 13, there were no differences in the antibody concentrations compared to antibody concentrations following the 4th dose of either pneumococcal 7-valent conjugate vaccine or Prevnar 13. In children 10-17 years, functional antibody responses were comparable to those in the 5 to <10 years age group after each group received a single dose of Prevnar 13.
Adults ≥18 Years: Prevnar 13 is to be administered as a single dose to adults ≥18 years including those previously vaccinated with a pneumococcal polysaccharide vaccine.
The need for re-vaccination with a subsequent dose of Prevnar 13 has not been established.
Special Populations: Individuals who may be at higher risk of pneumococcal infection (eg, individuals with sickle cell disease or HIV infection) including those previously vaccinated with ≥1 doses of 23-valent pneumococcal polysaccharide vaccine (PPSV23) may receive at least 1 dose of Prevnar 13.
In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunization series consists of 4 doses of Prevnar 13, each of 0.5 mL. The primary series consists of 3 doses, with the 1st dose given 3-6 months after HSCT and with an interval of at least 1 month between doses. A booster dose is recommended 6 months after the 3rd dose (see Pharmacology: Pharmacodynamics under Actions).
Geriatric Use: Prevnar 13 has been shown to be safe and immunogenic in the geriatric population (see Pharmacology: Pharmacodynamics under Actions).
Of the 5667 adults in the 6 studies (6115A1-004, 6115A1-3005, 6115A1-3010, 6115A1-3000, 6115A1-3001, 6115A1-3008) of the clinical development program who received Prevnar 13, 1785 (31.5%) were 65-74 years and 1266 (22.3%) were ≥75 years. No clinically significant differences in safety or immunogenicity were observed between 65-74 years individuals and >75 year old individuals.
Administration: For IM use only.
The dose is 0.5 mL given IM, with care to avoid injection into or near nerves and blood vessels. The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants and young children or the deltoid muscle of the upper arm in older children and adults. Prevnar 13 should not be injected in the gluteal area. Do not administer Prevnar 13 intravascularly.
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