Status:
COMPLETED
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
60-64 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Male or female adults \>/= 60 to \</=64 years of age (from the 60th birthday up to, but not including, the 65th birthday) at enrollment.
- 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.
- Female subjects who are not 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.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT03313037
Start Date
October 10 2017
End Date
December 10 2018
Last Update
December 26 2019
Active Locations (14)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
2
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
3
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
4
Qps-Mra, Llc
South Miami, Florida, United States, 33143