General Information

Prevnar 13 is specifically indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19F and 23F and for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. Prevnar 13 is approved for use in children 6 weeks through 5 years of age.

Mechanism of Action

Prevnar 13 is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. B-cells produce antibodies in response to antigenic stimulation via T-dependent and T-independent mechanisms. Prevnar 13, comprised of polysaccharides conjugated to a carrier protein, elicits a T-cell-dependent immune response. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response and generation of B-cell memory. This type of response induces immune memory and elicits booster responses on re-exposure in infants and young children to pneumococcal polysaccharides.

Side Effects

Adverse events associated with the use of Prevnar 13 may include, but are not limited to, the following:

• Injection site reactions
• Fever
• Decreased appetite
• Irritability
• Sleep issues
• Diarrhea
• Vomiting
• Rash

Dosing/Administration

Prevnar 13 is supplied as a solution for intramuscular injection. The vaccine should be administered accordingly:
 

Vaccine Schedule for Infants and Toddlers
The vaccine is to be administered as a four-dose series at 2, 4, 6 and 12-15 months of age.
 

Vaccine Schedule for Unvaccinated Children ≥7 Months of Age
Seven to 11 months of age: 3 doses at 0.5 mL. The first two doses at least four weeks apart; third dose after the one-year birthday, separated from the second dose by at least two months.
Twelve to 23 months of age: two doses at least two months apart at 0.5mL.
Twenty-four months through 5 years of age: one dose at 0.5mL.

Prevnar 13 Vaccine Schedule for Children Previously Vaccinated with Prevnar

Children who have received one or more doses of Prevnar may complete the four-dose immunization series with Prevnar 13.

Clinical Trial Results

FDA Approval
The effectiveness of Prevnar 13 against invasive pneumococcal disease was inferred from comparative studies to a U.S. licensed seven-valent pneumococcal conjugate vaccine, Prevnar. A randomized, double-blind, active-controlled trial pivotal U.S. non-inferiority study was conducted in 2-month-old infants who were randomly assigned to receive either Prevnar 13 or Prevnar. Immune responses were compared in subjects receiving either Prevnar 13 or Prevnar using a set of non-inferiority criteria. Co-primary end points included the percentage of subjects with serum pneumococcal anti-capsular polysaccharide IgG &gr;0.35 µg/mL measured one month after the third dose and serum pneumococcal anti-capsular polysaccharide IgG geometric mean concentrations (GMCs) one month after the fourth dose.

 
Pneumococcal Immune Responses Following Three Doses
The primary end point was met for 10 of the 13 serotypes. The exceptions were serotypes 6B, 9V and 3.
 

Pneumococcal Immune Responses Following Four Doses
Post-dose antibody concentrations were higher for all 13 serotypes than those achieved after the third dose. The non-inferiority criterion for pneumococcal anti-capsular polysaccharide GMCs after four doses was met for 12 of the 13 pneumococcal serotypes. The non-inferiority criterion was not met for the response to serotype 3.