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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:2/7/2015
Start Date:September 2014
End Date:September 2015
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.

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.


Inclusion Criteria:

1. 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.

2. Male or female adults 50 years of age or older.

3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1
year prior to study enrollment.

4. Negative urine pregnancy test for all female subjects who are of child bearing
potential.

Exclusion Criteria:

1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational
pneumococcal conjugate vaccine.

2. History of severe adverse reactions associated with any vaccine or vaccine-related
component.

3. Allergic to egg proteins (egg or egg products) and chicken proteins.

4. History of Guillain-Barré syndrome.

5. Vaccination with any influenza vaccine within 6 months (182 days) before
investigational product administration.

6. Documented S pneumoniae infection within the past 5 years before investigational
product administration.
We found this trial at
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Jacksonville, Florida 32205
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Austin, Texas
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Bellevue, Nebraska 68005
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Binghamton, New York 13901
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Bristol, Tennessee 37620
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Carnegie, Pennsylvania 15106
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Columbus, Ohio 43212
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Downington, Pennsylvania 19335
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East Greenwich, Rhode Island 02818
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Endwell, New York 13760
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Fort Worth, Texas 76135
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Fort Worth, Texas 76135
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Franklin, Ohio 45005
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Greensboro, North Carolina 27408
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Hickory, North Carolina 28602
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Huntsville, Alabama 35802
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Knoxville, Tennessee 37920
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Las Vegas, Nevada 89128
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Las Vegas, Nevada 89104
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Lenexa, Kansas 66219
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Metairie, Louisiana 70006
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Miami, Florida 33165
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Mt. Pleasant, South Carolina 29464
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Murray, Utah 84123
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Norfolk, Nebraska 68701
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Omaha, Nebraska 68134
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Pinellas Park, Florida 33781
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Rochester, New York 14609
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Sacramento, California 95823
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San Angelo, Texas 76904
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San Francisco, California 94102
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Savannah, Georgia 31406
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Scottsdale, Arizona 85251
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South Bend, Indiana 46601
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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Winston-Salem, North Carolina 27103
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