Profile
General Information
Prevnar 20 is a 20-valent Pneumococcal Conjugate Vaccine.
Prevnar 20 is specifically indicated:
- for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age
- for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar
Dosing in Children: Administer Prevnar 20 as a 4-dose immunization series at 2, 4, 6, and 12 through 15 months of age.
Dosing in Adults: Administer Prevnar 20 as a single dose in adults 18 years of age and
older
Mechanism of Action
Protection against pneumococcal disease is conferred mainly by antibodies (immunoglobulin G [IgG] directed against capsular polysaccharides) and OPA killing of S. pneumoniae. Prevnar 20 induces IgG antibodies and OPA against the 20 vaccine serotypes. An opsonic antibody titer or serotype-specific IgG concentration that is predictive of protection against invasive pneumococcal disease or pneumococcal pneumonia has not been established.
Side Effects
Adverse effects associated with the use of Prevnar20 may include, but are not limited to, the following:
- irritability
- pain at the injection site
- drowsiness
- decreased appetite
- injection site redness
- injection site swelling
- fever
Clinical Trial Results
FDA approval was based on results from the Phase 2 and Phase 3 clinical trial programs for the pediatric indication for PREVNAR 20. Three core Phase 3 pediatric studies contributed to data on the safety, tolerability, and immunogenicity of PREVNAR 20.
A pivotal U.S. Phase 3 study in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.
The study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series, respectively: non-inferiority (NI) of the percentage of participants with predefined serotype-specific immunoglobin G (IgG) concentrations after Dose 3 and NI of IgG geometric mean concentrations (GMCs) after Dose 4. All 20 serotypes met the co-primary objective of NI of IgG GMCs after Dose 4. Fourteen of the 20 serotypes met the co-primary objective of NI of the percentage of participants with predefined IgG levels after Dose 3 (two serotypes missed by a wider margin while four narrowly missed), and all serotypes met noninferiority for the key secondary objective of IgG GMCs after Dose 3. All 20 serotypes elicited robust functional responses (OPA) and increases in antibody responses after Dose 4, with the totality of data supporting the potential benefit of all serotypes in this 20-valent vaccine candidate.
A phase 3 study, which evaluated the safety and immunogenicity of the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at one month after vaccination were met for all serotypes in common with licensed Prevnar 13 (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23).
A multicenter, randomized, active-controlled, double-blind phase study with a two-arm parallel design, conducted at investigator sites in the United States. There were 460 infants ages 42 to 98 days randomized (1:1) to receive either 20vPnC or Prevnar 13 at 2, 4, and 6 months of age (infant series, Doses 1 through 3) and 12 months of age (Dose 4). Other routine pediatric vaccines could be administered according to the current ACIP recommended schedule. Safety and immune responses were assessed in the study. 20vPnC elicited pneumococcal immune responses to all 20 serotypes one month after Dose 3 as measured by both the percentages of participants with prespecified serotype-specific IgG concentrations and IgG Geometric Means Concentrations (GMCs). Booster responses were observed for all serotypes after Dose 4 when comparing the serotype-specific IgG GMCs from one month after Dose 4 to responses both 1 month after Dose 3 and before Dose 4 indicating the induction of immunological memory. 20vPnC elicited functional antibody responses to all 20 serotypes at one month after Dose 3 and one month after Dose 4 as measured by OPA GMTs. Boosting of OPA responses was also observed for all serotypes after Dose 4 consistent with the trend observed with IgG responses.