A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age



Status:Active, not recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - 85
Updated:12/19/2018
Start Date:October 12, 2017
End Date:May 24, 2019

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

A Phase 1/2, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50 Through 85 Years Of Age

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a
2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination
will be randomized equally to receive either a single intramuscular dose of multivalent
pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis
combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2
months prior to investigational product administration will be randomized equally to receive
either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the
licensed 23-valent pneumococcal polysaccharide vaccine (control group).


Inclusion Criteria:

- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of
pneumococcal vaccination

- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated
with Prevnar 13 >= 2 months prior to investigational product administration

Exclusion Criteria:

- Stage 1: Vaccination within 12 months before investigational product administration
with diphtheria-, pertussis-, or tetanus-containing vaccine

- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
dose of Prevnar 13
We found this trial at
17
sites
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
1787
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
2559
mi
from 91732
Warwick, RI
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1186
mi
from 91732
Wichita, KS
Click here to add this to my saved trials
Augusta, Kansas 67010
1201
mi
from 91732
Augusta, KS
Click here to add this to my saved trials
Augusta, Kansas 67010
1201
mi
from 91732
Augusta, KS
Click here to add this to my saved trials
Bardstown, Kentucky 40004
1829
mi
from 91732
Bardstown, KY
Click here to add this to my saved trials
Cerritos, California 90703
15
mi
from 91732
Cerritos, CA
Click here to add this to my saved trials
Charleston, South Carolina 29407
2180
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28209
2101
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Newton, Kansas 67114
1183
mi
from 91732
Newton, KS
Click here to add this to my saved trials
Norfolk, Nebraska 68701
1243
mi
from 91732
Norfolk, NE
Click here to add this to my saved trials
Omaha, Nebraska 68134
1295
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
571
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
566
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
Savannah, Georgia 31406
2132
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
West Jordan, Utah 84088
559
mi
from 91732
West Jordan, UT
Click here to add this to my saved trials
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
2275
mi
from 91732
Wilmington, NC
Click here to add this to my saved trials