Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

Completed · Phase 3

Conditions studied: Pneumococcal Infections

In brief

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

Key facts

Study ID

NCT00427895

Run by

Pfizer

People needed

2141

Starts

2007-02-27

Expected to finish

2011-08-01

Last updated by the study team

2021-11-15

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
• Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
• Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

You may not qualify if…

• Previous immunization with any licensed or experimental pneumococcal vaccine.
• Serious chronic disorders 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 which in the investigator's opinion precludes the subject from participating in the study.
• Known or suspected impairment of immunological function.

Where it is running

• Accelovance — Huntsville, Alabama, United States
• East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Clinical Research Advantage/Central Phoenix — Phoenix, Arizona, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Accelovance — South Bend, Indiana, United States
• Heartland Research Associates LLC — Wichita, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Kentucky Pediatric /Adult Research — Bardstown, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Radiant Research - St. Louis — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• PMG Research of Raleigh, LLC — Cary, North Carolina, United States
• PMG Research of Raleigh, LLC — Raleigh, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Primary Physicians Research — Pittsburgh, Pennsylvania, United States
• Primary Physicians Research — Upper Saint Clair, Pennsylvania, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Internal Medicine and Pediatrics Associates of Bristol, PC — Bristol, Tennessee, United States
• PMG Research of Bristoll, LLC — Bristol, Tennessee, United States
• J. Lewis Research Inc./Foothill Family Clinic South — Salt Lake City, Utah, United States
• J. Lewis Research Inc./Foothill Family Clinic South — Salt Lake City, Utah, United States
• Advanced Clinical Research — West Jordan, Utah, United States
• J. Lewis Research/First Med — West Jordan, 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.