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
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San Jose, California 94538
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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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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Bardstown, Kentucky 40004
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Dakota Dunes, South Dakota 57049
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7261 Sheridan Street
Hollywood, Florida 33024
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Honolulu, Hawaii 96814
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Norfolk, Nebraska 68701
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Omaha, Nebraska 68134
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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Rochester, New York 14609
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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...
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Sacramento, California 95823
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Santa Clara, California 95051
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Stockbridge, Georgia 30281
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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...
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