Status:
COMPLETED
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- Male or female adults \>/= 18 years of age (from the 18th birthday) at enrollment and older.
- 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.
- Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.
Exclusion
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- 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.
- Pregnant female subjects or breastfeeding female subjects.
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2019
Estimated Enrollment :
3902 Patients enrolled
Trial Details
Trial ID
NCT03760146
Start Date
December 12 2018
End Date
December 16 2019
Last Update
December 2 2021
Active Locations (68)
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1
Accel Research Sites
Birmingham, Alabama, United States, 35216
2
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
3
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States, 85224
4
The Pain Center of Arizona
Peoria, Arizona, United States, 85381