Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age



Status:Active, not recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:60 - 64
Updated:8/5/2018
Start Date:October 10, 2017
End Date:December 10, 2018

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A Phase 2, Randomized, Double-blind Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Adults 60 Through 64 Years Of Age

This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy
adults aged 60 through 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 followed 1 month later with a dose of saline or Prevnar 13 followed 1 month
later with a dose of PPSV23 (control group).


Inclusion Criteria:

1. Male or female adults >/= 60 to not including, the 65th birthday) at enrollment.

2. Healthy adults, including adults with preexisting stable disease, defined as disease
not requiring significant change in therapy or requiring hospitalization within 3
months before receipt of investigational product, as determined by medical history,
physical examination, laboratory screening, and clinical judgment of the investigator.

3. Female subjects who are not of childbearing potential.

Exclusion Criteria:

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.

2. History of microbiologically proven invasive disease caused by S pneumoniae.

3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
or without dialysis, clinically unstable cardiac disease, or any other disorder that,
in the investigator's opinion, excludes the subject from participating in the study.
We found this trial at
14
sites
3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Austin, Texas
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Charleston, South Carolina 29407
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801 Monterey Street
Coral Gables, Florida 33134
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Draper, UT
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Honolulu, Hawaii 96814
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South Jordan, UT
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South Miami, Florida 33143
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Stockbridge, Georgia 30281
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Tomball, Texas 77375
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