Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER

Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone

Inclusion Criteria:

• Male or female participants ≥65 years of age at the time of consent
• Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2
• Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease
• Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study

Exclusion Criteria:

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
• Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
• Previous clinical or microbiological diagnosis of COVID-19
• Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
• Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study