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 |
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.
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
47
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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