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

B7471026

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

2021-05-20

2021-12-08

2021-12-08

Completed

Early phase I

570

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

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2022-12-14