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 NaÃ¯ve 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
naÃ¯ve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

We found this trial at

sites

Raleigh Regional Cancer Center

Beckley, West Virginia 25801

from

Beckley, WV