20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
NCT ID: NCT04382326
Last Updated: 2023-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1997 participants
INTERVENTIONAL
2020-05-20
2022-09-02
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
QUADRUPLE
Study Groups
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20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Interventions
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20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for 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 receipt of \>1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at \>30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
42 Days
98 Days
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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Children's of Alabama
Birmingham, Alabama, United States
UAB Pediatric Primary Care Clinic at Children's of Alabama
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
MedPharmics, LLC
Phoenix, Arizona, United States
Northwest Arkansas Pediatrics
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Gardens Medical Center
Bell Gardens, California, United States
Coast Clinical Research, LLC
Bellflower, California, United States
Priti Desai, M.D. Inc.
Covina, California, United States
Universal Biopharma Research Institute Inc.
Fresno, California, United States
Matrix Clinical Research
Gardena, California, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, United States
Kaiser Permanente Oakland
Oakland, California, United States
Orange County Research Institute
Ontario, California, United States
Center for Clinical Trials of San Gabriel
West Covina, California, United States
Children's Colorado Health Pavilion (Child Health Clinic)
Aurora, Colorado, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, United States
Optumcare Colorado Springs, LLC
Colorado Springs, Colorado, United States
Gentle Medicine Associates
Boynton Beach, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Benton Pediatrics
Gainesville, Florida, United States
Qway Research
Hialeah, Florida, United States
Next Phase Research Alliance
Homestead, Florida, United States
Axcess Medical Research
Loxahatchee Groves, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Bio-Medical Research, LLC
Miami, Florida, United States
Crystal Biomedical Research, LLC
Miami Lakes, Florida, United States
Children's Health Center
Tampa, Florida, United States
Tekton Research, Inc
Chamblee, Georgia, United States
Uptown Pediatrics
Columbus, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Meridian Clinical Research
Macon, Georgia, United States
Omega Pediatrics
Roswell, Georgia, United States
Idaho Falls Pediatrics
Ammon, Idaho, United States
Idaho Falls Pediatrics
Idaho Falls, Idaho, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Family First Medical Center
Idaho Falls, Idaho, United States
Snake River Research, PLLC
Idaho Falls, Idaho, United States
The Pediatric Center
Idaho Falls, Idaho, United States
Saltzer Health
Nampa, Idaho, United States
ASR, LLC
Nampa, Idaho, United States
The Iowa Clinic
Ankeny, Iowa, United States
Blank Children's Pediatric Clinic
Des Moines, Iowa, United States
Unity Point Health
Des Moines, Iowa, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Alliance for Multispecialty Research, LLC
El Dorado, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Michael W. Simon, MD, PSC
Lexington, Kentucky, United States
Novak Center for Children's Health
Louisville, Kentucky, United States
Brownsboro Park Pediatrics
Louisville, Kentucky, United States
Velocity Clinical Research at Primary Pediatrics, Macon
Baton Rouge, Louisiana, United States
Benchmark Research
Covington, Louisiana, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Velocity Clinical Research, Covington
Metairie, Louisiana, United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States
The Pediatric Center of Frederick, LLC
Frederick, Maryland, United States
MedPharmics, LLC
Gulfport, Mississippi, United States
Boeson Research
Missoula, Montana, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Children's Physicians Dundee
Omaha, Nebraska, United States
Medpharmics
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Child Health Care Associates
East Syracuse, New York, United States
Smart Medical Research, Inc
Jackson Heights, New York, United States
Child Health Care Associates
Liverpool, New York, United States
ECU Physicians Adult and Pediatric Health Center
Greenville, North Carolina, United States
ECU Physicians Pediatric Outpatient Clinic
Greenville, North Carolina, United States
Leo Jenkins Cancer Center Pharmacy
Greenville, North Carolina, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, United States
Pediatric Associates of Fairfield
Fairfield, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Pediatric Medical Associates
East Norriton, Pennsylvania, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Lockman & Lubell Pediatric Associates
Fort Washington, Pennsylvania, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
Sanford 69th & Louise Family Medicine
Sioux Falls, South Dakota, United States
Holston Medical Group
Bristol, Tennessee, United States
Premier Medical Group
Clarksville, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
LeBonheur Children's Hospital
Memphis, Tennessee, United States
Coastal Bend Clinical Research
Corpus Christi, Texas, United States
Kool Kids Pediatrics
Houston, Texas, United States
La Providence Pediatrics Clinic
Houston, Texas, United States
Houston Clinical Research Associates
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Diagnostic Clinic of Longview
Longview, Texas, United States
Ashley Pediatrics Day and Night Clinic
McAllen, Texas, United States
Dr. Ruben Aleman & Associates
McAllen, Texas, United States
Tekton Research, Inc
San Antonio, Texas, United States
Wee Care Pediatrics
Kaysville, Utah, United States
Wee Care Pediatrics
Layton, Utah, United States
Wasatch Pediatrics, Cottonwood Office
Murray, Utah, United States
Wee Care Pediatrics
Roy, Utah, United States
Dixie Pediatrics
St. George, Utah, United States
Wee Care Pediatrics
Syracuse, Utah, United States
Pediatric Associates of Charlottesville, PLC
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
The Vancouver Clinic, Inc
Vancouver, Washington, United States
San Miguel Medical
Trujillo Alto, PR, Puerto Rico
Cooperativa de Facultad Medica Sanacoop DBA Instituto Sanacoop
Bayamón, , Puerto Rico
Clinical Research Puerto Rico
Guayama, , Puerto Rico
Hispanic Alliance for Clinical and Translational Research
San Juan, , Puerto Rico
San Juan Hospital
San Juan, , Puerto Rico
Countries
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References
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Senders S, Klein NP, Tamimi N, Thompson A, Baugher G, Trammel J, Peng Y, Giardina P, Scully IL, Pride M, Center KJ, Gruber WC, Scott DA, Watson W. A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2024 Jun 1;43(6):596-603. doi: 10.1097/INF.0000000000004334. Epub 2024 Mar 26.
Mt-Isa S, Chumbley JR, Crawford EL, Banniettis N, Buchwald UK, Weaver J, Weiss T. An indirect treatment comparison (ITC) and matching-adjusted indirect comparison (MAIC) between a 15-valent (V114) and a 20-valent (PCV20) pneumococcal conjugate vaccine among healthy infants. Expert Rev Vaccines. 2023 Jan-Dec;22(1):906-917. doi: 10.1080/14760584.2023.2270039. Epub 2023 Oct 19.
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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2019-003305-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471011
Identifier Type: -
Identifier Source: org_study_id