Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
NCT ID: NCT04526574
Last Updated: 2022-07-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1796 participants
INTERVENTIONAL
2020-09-01
2021-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Coadministration Group
Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Saline
Normal saline for injection
Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)
Separate Administration Group
Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Saline
Normal saline for injection
Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)
Interventions
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Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
Saline
Normal saline for injection
Influenza vaccine
Seasonal inactivated influenza vaccine (SIIV)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
Paradigm Clinical Research Center
Redding, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Research Foundation
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC - Miami
Coral Gables, Florida, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Indago Research and Health Center, Inc.
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Alpha Science Research, LLC
Miami, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Advanced Clinical Research
Meridian, Idaho, United States
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Meridian Clinical Research, LLC
Binghamton, New York, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Accellacare - Raleigh
Raleigh, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Meridian Clinical Research
Cincinnati, Ohio, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Omega Medical Research
Warwick, Rhode Island, United States
Main Street Physician's Care
Little River, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Texas Health Resource
Fort Worth, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Wellness Clinical Research
McKinney, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc / Jordan River Family Medicine
South Jordan, Utah, United States
Alliance for Multispecialty Research - Norfolk
Norfolk, Virginia, United States
National Clinical Research, Inc
Richmond, Virginia, United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, United States
Countries
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References
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Cannon K, Cardona JF, Yacisin K, Thompson A, Belanger TJ, Lee DY, Peng Y, Moyer L, Ginis J, Gruber WC, Scott DA, Watson W. Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine coadministered with quadrivalent influenza vaccine: A phase 3 randomized trial. Vaccine. 2023 Mar 24;41(13):2137-2146. doi: 10.1016/j.vaccine.2022.11.046. Epub 2023 Feb 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7471004
Identifier Type: -
Identifier Source: org_study_id
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