A Study of the Safety, Tolerability, and Immunogenicity of V114 Compared With Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-valent Pneumococcal Polysaccharide Vaccine (V114-007)



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:65 - Any
Updated:1/16/2016
Start Date:October 2015
End Date:February 2016
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

This study is designed to assess the safety, tolerability, and immunogenicity of V114
compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated
with 23-valent pneumococcal polysaccharide vaccine.


Inclusion Criteria:

- Good health; any underlying chronic illness must be documented to be in stable
condition

- Have documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine one
year or longer prior to study entry.

- Male, or postmenopausal female

Exclusion Criteria:

- Prior administration of any pneumococcal vaccine other than 23-valent pneumococcal
polysaccharide vaccine

- History of invasive pneumococcal disease or known history of other culture-positive
pneumococcal disease

- Known hypersensitivity to any vaccine component

- Known or suspected impairment of immune function

- Received systemic corticosteroids for >=14 consecutive days and has not completed
treatment <=30 days prior to study entry, or received systemic corticosteroids
exceeding physiologic replacement doses within 14 days prior to study vaccination

- Coagulation disorder contraindicating intramuscular vaccination

- Receives immunosuppressive therapy, including chemotherapeutic agents used to treat
cancer or other conditions, and treatments associated with organ or bone marrow
transplantation, or autoimmune disease

- Received a blood transfusion or blood products, including immunoglobulins within the
6 months before receipt of study vaccine or is scheduled to receive a blood
transfusion or blood product within 30 days of receipt of study vaccine. Autologous
blood transfusions are not considered an exclusion criterion

- Participated in another clinical study of an investigational product within 2 months
before the beginning of or any time during the duration of the current clinical study

- User of recreational or illicit drugs or has had a recent history (within the last
year) of drug or alcohol abuse or dependence.
We found this trial at
17
sites
?
mi
from 43215
DeLand, FL
Click here to add this to my saved trials
110
mi
from 43215
Akron, OH
Click here to add this to my saved trials
198
mi
from 43215
Bardstown, KY
Click here to add this to my saved trials
369
mi
from 43215
Cary, NC
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
618
mi
from 43215
Kansas City, MO
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
1109
mi
from 43215
New Braunfels, TX
Click here to add this to my saved trials
779
mi
from 43215
Newton, KS
Click here to add this to my saved trials
355
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
1518
mi
from 43215
South Jordan, UT
Click here to add this to my saved trials
2083
mi
from 43215
Walnut Creek, CA
Click here to add this to my saved trials
306
mi
from 43215
Winston-Salem, NC
Click here to add this to my saved trials