Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age

Completed · Phase 1

Conditions studied: Pneumococcal Disease

In brief

The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.

Key facts

Study ID

NCT05489328

Run by

Pfizer

People needed

394

Starts

2022-08-15

Expected to finish

2022-10-07

Last updated by the study team

2024-04-18

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female participants ≥18 and ≤49 years of age at the time of consent
• Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
• Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children

You may not qualify if…

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
• Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
• Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
• Known or suspected immunodeficiency or other conditions associated with immunosuppression
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
• Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention

Where it is running

• Orange County Research Center — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Clinical Research Consulting — Milford, Connecticut, United States
• Proactive Clinical Research,LLC — Fort Lauderdale, Florida, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• Qps-Mra, Llc — South Miami, Florida, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
• Prism Research LLC dba Nucleus Network — Saint Paul, Minnesota, United States
• South Jersey Infectious Disease — Somers Point, New Jersey, United States
• Accellacare - Wilmington — Wilmington, North Carolina, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• IMA Clinical Research San Antonio — San Antonio, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
• J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States
• Alliance for Multispecialty Research, LLC — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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