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

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection

Interventions: 20-valent pneumococcal conjugate vaccine (20vPnC), BNT162b2, Saline

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (27)

Anaheim, California, United States
Walnut Creek, California, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Stockbridge, Georgia, United States
Honolulu, Hawaii, United States
Meridian, Idaho, United States
Newton, Kansas, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Endwell, New York, United States
Wilmington, North Carolina, United States
Columbus, Ohio, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Tomball, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Wenatchee, Washington, United States