Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
| Status: | Archived |
|---|---|
| Conditions: | Pneumonia, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Compared to a 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) in Adults 60 to 64 Years Old Who Are Naive to 23vPS and the Safety, Tolerability, and Immunogenicity of 13vPnC in Adults 18 to 59 Years Old Who Are Naïve to 23vPS
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.
We found this trial at
16
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Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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601 Elmwood Ave
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Strong Memorial Hospital (University of Rochester School of Medicine) In addition to offering traditional and...
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