Trial to Evaluate the Safety and Immunogenicity of a 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 - Any |
Updated: | 3/28/2019 |
Start Date: | December 12, 2018 |
End Date: | January 2, 2020 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a
20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Inclusion Criteria:
1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and
older.
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. Negative urine pregnancy test at Visit1 for all subjects who are 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.
4. Pregnant female subjects or breastfeeding female subjects.
We found this trial at
55
sites
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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