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

Completed · Phase 3

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

In brief

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

Key facts

Study ID

NCT04887948

Run by

Pfizer

People needed

570

Starts

2021-05-20

Expected to finish

2021-12-08

Last updated by the study team

2022-12-14

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Alliance for Multispecialty Research, LLC — Coral Gables, Florida, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• Research Centers of America ( Hollywood ) — Hollywood, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Alliance for Multispecialty Research, LLC — Newton, Kansas, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Meridian Clinical Research, LLC — Endwell, New York, United States
• Accellacare - Wilmington — Wilmington, North Carolina, United States
• Aventiv Research Inc — Columbus, Ohio, United States
• Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Memphis, Tennessee, United States
• Benchmark Research — Austin, Texas, United States
• IMA Clinical Research San Antonio — San Antonio, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• Martin Diagnostic Clinic — Tomball, Texas, United States
• Martins Diagnostic Clinic — Tomball, Texas, United States
• J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.