Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza

In brief

This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.

Key facts

Study ID

NCT00521586

Run by

Pfizer

People needed

1116

Starts

2007-09-01

Expected to finish

2013-12-01

Last updated by the study team

2015-04-09

Who can join

Age: 50 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female aged 50 to 59 years
• Determined by medical history, physical examination and clinical judgement to be eligible for the study
• Able to complete electronic diary
• Available for the 5 year 9 month duration of the study

You may not qualify if…

• Previous vaccination with any licensed or experimental pneumococcal vaccine
• Allergic to egg proteins and chicken proteins
• History of Guillian-Barre syndrome
• Vaccination with TIV within 6 months before study start
• Vaccination with diphtheria-containing vaccine within 6 months of study start
• Serious chronic disorders including immunodeficiency or metastatic malignancy
• Known or suspected hypersensitivity to any vaccine or vaccine component

Where it is running

• Clinical Research Advantage, Inc. — Chandler, Arizona, United States
• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials — Aurora, Colorado, United States
• Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
• A. G. A. Clinical Trials — Hialeah, Florida, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Accelovance — Peoria, Illinois, United States
• Suite 100 — Riverdale, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Radiant Research, Inc — St Louis, Missouri, United States
• Big Sky Clinical Research — Butte, Montana, United States
• FFM Clinical Research — Camillus, New York, United States
• Rochester Clinical Research — Rochester, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• PMG Research of Raleigh, LLC — Cary, North Carolina, United States
• Hickory Family Practice Associates — Hickory, North Carolina, United States
• PMG Research of Hickory, LLC — Hickory, North Carolina, United States
• Unifour Medical Research Associates, LLC — Hickory, North Carolina, United States
• Unifour Medical Research Associates — Hickory, North Carolina, United States
• Fairbrook Medical Clinic — Hickory, North Carolina, United States
• PMG Research of Hickory, LLC — Hickory, North Carolina, United States
• Unifour Medical Research Associates, LLC — Hickory, North Carolina, United States
• PMG Research of Raleigh, LLC — Raleigh, North Carolina, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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