Status:
COMPLETED
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
Eligibility Criteria
Inclusion
- Male or female participants ≥65 years of age at the time of consent
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
- Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.
Exclusion
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
- Vaccination with any influenza or pneumococcal vaccine \<6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
- \-- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
1796 Patients enrolled
Trial Details
Trial ID
NCT04526574
Start Date
September 1 2020
End Date
June 29 2021
Last Update
July 8 2022
Active Locations (63)
Enter a location and click search to find clinical trials sorted by distance.
1
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
2
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States, 85224
3
Hope Research Institute
Phoenix, Arizona, United States, 85018
4
Paradigm Clinical Research Center
Redding, California, United States, 96001