Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
NCT ID: NCT04642079
Last Updated: 2024-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
839 participants
INTERVENTIONAL
2020-12-04
2022-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Cohort 1: =>15 through 23 months of age
20vPnC
20vPnC
20-valent pneumococcal conjugate vaccine
Cohort 2: 2 through 4 years of age
20vPnC
20vPnC
20-valent pneumococcal conjugate vaccine
Cohort 3: 5 through 9 years of age
20vPnC
20vPnC
20-valent pneumococcal conjugate vaccine
Cohort 4: 10 through 17 years of age
20vPnC
20vPnC
20-valent pneumococcal conjugate vaccine
Interventions
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20vPnC
20-valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* For children \<5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered \>2 months before enrolment into the study
Exclusion Criteria
* Major known congenital malformation or serious chronic disorder
* 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
* Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
* Cohorts 3 and 4: Pregnant or breastfeeding female participants
15 Months
17 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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Northwest Arkansas Pediatrics
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
The Children's Clinic
Jonesboro, Arkansas, United States
California Research Foundation
San Diego, California, United States
Pharmax Research Clinic, Inc.
Miami, Florida, United States
Bio-Medical Research, LLC
Miami, Florida, United States
Children's Health Center
Tampa, Florida, United States
Tekton Research, Inc
Chamblee, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Meridian Clinical Research, LLC
Sioux City, Iowa, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Michael W. Simon, M.D., PSC
Lexington, Kentucky, United States
MedPharmics, LLC
Gulfport, Mississippi, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Velocity Clinical Research, Sioux City
Omaha, Nebraska, United States
Wr-Crcn, Llc
Henderson, Nevada, United States
MedPharmic's, LLC
Albuquerque, New Mexico, United States
Meridian Clinical Research, LLC
Binghamton, New York, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Association Inc.
Dayton, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Lockman & Lubell Pediatric Associates
Fort Washington, Pennsylvania, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
Benchmark Research
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Tekton Research, Inc
San Antonio, Texas, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
Wasatch Pediatrics, Cottonwood Office
Murray, Utah, United States
Pediatric Care
Provo, Utah, United States
JBR Clinical Research
Salt Lake City, 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
CopperView Medical Center
South Jordan, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Wee Care Pediatrics
Syracuse, Utah, United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Countries
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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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B7471014
Identifier Type: -
Identifier Source: org_study_id
2019-003308-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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