Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumococcal Disease

In brief

A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Key facts

Study ID

NCT03760146

Run by

Pfizer

People needed

3902

Starts

2018-12-12

Expected to finish

2019-12-16

Last updated by the study team

2021-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
• Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
• Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

You may not qualify if…

• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
• History of microbiologically proven invasive disease caused by S pneumoniae.
• Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
• Pregnant female subjects or breastfeeding female subjects.

Where it is running

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• East Valley Gastroenterology and Hepatology Associates — Chandler, Arizona, United States
• The Pain Center of Arizona — Peoria, Arizona, United States
• MedPharmics, LLC — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Clinical Research Consulting, LLC — Milford, Connecticut, United States
• Nature Coast Clinical Research — Crystal River, Florida, United States
• Accel Research Sites - Clinical Research Unit — DeLand, Florida, United States
• Research Centers of America, LLC — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Qps-Mra, Llc — South Miami, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Meridian Clinical Research LLC — Savannah, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Axtell Clinic, P.A. — Newton, Kansas, United States
• Heartland Research Associates, LLC — Newton, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Northwest Family Physicians — Wichita, Kansas, United States
• Accel Research Sites — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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