Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Completed · Phase 3

Conditions studied: Pneumococcal Disease

In brief

This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.

Key facts

Study ID

NCT03828617

Run by

Pfizer

People needed

1710

Starts

2019-02-14

Expected to finish

2019-10-09

Last updated by the study team

2020-11-23

Who can join

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

You may qualify if…

• Male or female adults ≥18 and <50 years of age.
• 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.
• Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.

You may not qualify if…

• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
• 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.
• History of microbiologically proven invasive disease caused by S pneumoniae.
• Pregnant female subjects or breastfeeding female subjects (known or suspected).

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Kaiser Permanente Sacramento — Sacramento, California, United States
• Kaiser Permanente South Sacramento — Sacramento, California, United States
• Kaiser Permanente San Jose — San Jose, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• Accel Research Sites - Clinical Research Unit — DeLand, Florida, United States
• Research Centers of America, LLC — Hollywood, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• East West Medical Research Institute — Honolulu, Hawaii, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• M3 Wake Research, Inc. — Raleigh, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Meridian Clinical Research, LLC — Dakota Dunes, South Dakota, United States
• Benchmark Research — Austin, 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

Full record on ClinicalTrials.gov

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