Status:
COMPLETED
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
COVID-19
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT04887948
Start Date
May 20 2021
End Date
December 8 2021
Last Update
December 14 2022
Active Locations (27)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
2
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
3
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States, 33134
4
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012