Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 49
Updated:3/28/2019
Start Date:February 14, 2019
End Date:December 16, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE

This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18
through 49 years of age with no history of pneumococcal vaccination will be randomized in a
2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
13vPnC.


Inclusion Criteria:

1. Male or female adults ≥18 and <50 years of age.

2. Adults determined by clinical assessment, including medical history and clinical
judgment, to be eligible for the study, including adults with preexisting stable
disease, defined as disease not requiring significant change in therapy in the
previous 6 weeks or hospitalization for worsening disease within 12 weeks before
receipt of investigational product.

3. Female subject of childbearing potential or male subject who is able to father
children, and willing to use a highly effective method of contraception as outlined in
this protocol for at least 28 days after the dose of investigational product; or
female subject not of childbearing potential or male subject not able to father
children.

Exclusion Criteria:

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

2. 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.

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

4. Pregnant female subjects or breastfeeding female subjects (known or suspected).
We found this trial at
20
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Stockbridge, Georgia 30281
448
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Stockbridge, GA
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
615
mi
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Warwick, RI
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
781
mi
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Wichita, KS
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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...
1960
mi
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Anaheim, CA
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Austin, Texas
1065
mi
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Austin, TX
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Bardstown, Kentucky 40004
198
mi
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Bardstown, KY
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Dakota Dunes, South Dakota 57049
720
mi
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Dakota Dunes, SD
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761
mi
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DeLand, FL
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7261 Sheridan Street
Hollywood, Florida 33024
975
mi
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Hollywood, FL
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Honolulu, Hawaii 96814
4501
mi
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Honolulu, HI
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Norfolk, Nebraska 68701
762
mi
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Norfolk, NE
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Omaha, Nebraska 68134
688
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Omaha, NE
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3100 Duraleigh Road
Raleigh, North Carolina 27612
370
mi
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Raleigh, NC
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Rochester, New York 14609
356
mi
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Rochester, NY
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
2043
mi
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Sacramento, CA
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Sacramento, California 95823
2043
mi
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Sacramento, CA
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1506
mi
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Salt Lake City, UT
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San Jose, California 94538
2088
mi
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San Jose, CA
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Santa Clara, California 95051
2091
mi
from 43215
Santa Clara, CA
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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...
484
mi
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Wilmington, NC
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