Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

Completed · Phase 4 · Has a placebo group

Conditions studied: PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE

In brief

The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.

Key facts

Study ID

NCT02124161

Run by

Pfizer

People needed

882

Starts

2014-09-01

Expected to finish

2015-05-01

Last updated by the study team

2016-07-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
• Male or female adults 50 years of age or older.
• Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
• Negative urine pregnancy test for all female subjects who are of child bearing potential.

You may not qualify if…

• Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
• History of severe adverse reactions associated with any vaccine or vaccine-related component.
• Allergic to egg proteins (egg or egg products) and chicken proteins.
• History of Guillain-Barré syndrome.
• Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
• Documented S pneumoniae infection within the past 5 years before investigational product administration.

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Optimal Research (Formerly Accelovance) — Huntsville, Alabama, United States
• Radiant Research, Inc. — Scottsdale, Arizona, United States
• Kaiser Permanente Vaccine Study Center — Oakland, California, United States
• Kaiser Permanante South. Sacramento — Sacramento, California, United States
• Benchmark Research — San Francisco, California, United States
• Kaiser Pemanente Santa Clara — Santa Clara, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Radiant Research, Inc. — Pinellas Park, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Optimal Research, LLC — Mishawaka, Indiana, United States
• Clinical Research Advantage, Inc/Ridge Family Practice — Council Bluffs, Iowa, United States
• Johnson County Clin-Trials, Inc. — Lenexa, Kansas, United States
• Benchmark Research — Metairie, Louisiana, United States
• Meridian Clinical Research — Bellevue, Nebraska, United States
• Meridian Clinical Research — Norfolk, Nebraska, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Clinical Research Center of Nevada, LLC — Las Vegas, Nevada, United States
• Clinical Research Advantage, Inc. — Las Vegas, Nevada, United States
• United Medical Associates — Binghamton, New York, United States
• Regional Clinical Research, Inc. — Endwell, New York, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• PMG Research of Raleigh, LLC d/b/a PMG Research of Cary — Cary, North Carolina, United States

Full record on ClinicalTrials.gov

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