PREVNAR 20 Rx

The approval of Prevnar 20 was based on evidence from several clinical trials including three phase 3 studies involving more than 6000 adult participants. In an active-controlled, double-blind noninferiority trial (ClinicalTrials.gov Identifier: NCT03760146), 3880 pneumococcal vaccine-naïve adults were enrolled into 1 of 3 cohorts based on their age and were randomly assigned to receive either Prevnar 20 or control.

The trial was designed to compare immune responses in patients 60 years of age and older after Prevnar 20 administration to responses in a control group receiving 13-valent pneumococcal conjugate vaccine (Prevnar 13) followed 1 month later with 23-valent polysaccharide vaccine (PPSV23). The immune responses to Prevnar 20 in patients aged 18 to 59 years were also assessed, along with the safety profile of Prevnar 20 in all patients.

Results showed that the primary immunogenicity objectives of noninferiority for the 20 serotypes in Prevnar 20 in patients aged 60 years and older at 1 month after vaccination were met for all serotypes in common with Prevnar 13, and 6 of the 7 additional serotypes when compared with PPSV23; 1 of the new 7 serotypes missed noninferiority by a small margin.

When measured 1 month after vaccination, Prevnar 20 also elicited serotype-specific immune responses to each of the 20 vaccine serotypes in both of the younger age groups (18-49 years and 50-59 years) that were within 2-fold of the corresponding serotype-specific responses in adults 60 to 64 years of age.

Immunogenicity of Prevnar 20 in Adults Previously Vaccinated With Pneumococcal Vaccine

• Randomized, open-label trial evaluated immune responses to Prevnar 20 in adults 65 years and older previously vaccinated with PPSV23 (≥1 to ≤5 years prior to enrollment), previously vaccinated with Prevnar 13 (≥6 months prior to enrollment), or previously vaccinated with Prevnar 13 followed by PPSV23 (with PPSV23 vaccination ≥1 year prior to enrollment). 
• Immune responses in participants who received PPSV23 1 to 5 years prior to Prevnar 20 were diminished compared with immune responses in participants who received Prevnar 13 at least 6 months previously and compared with immune responses in participants who received Prevnar 13 followed by PPSV23, with the last PPSV23 dose given at least 1 year prior to Prevnar 20.

Concomitant Vaccine Administration

• Double-blind study conducted in adults 65 years of age and older who had no history of prior pneumococcal vaccination or who had previously received PPSV23 and/or Prevnar 13 at least 6 months prior to enrollment.
• Study participants were randomly assigned to receive Prevnar 20 concomitantly with Fluad Quadrivalent followed approximately 1 month later by placebo or Fluad Quadrivalent concomitantly with placebo followed approximately 1 month later by Prevnar 20.
• The noninferiority criteria for the comparisons of OPA GMTs were met for all 20 pneumococcal serotypes in Prevnar 20. 
• The noninferiority criteria for the comparisons of HAI GMTs were also met for all 4 influenza vaccine strains.