Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
NCT ID: NCT03512288
Last Updated: 2021-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
460 participants
INTERVENTIONAL
2018-04-16
2020-02-11
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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Multivalent
Pneumococcal conjugate vaccines
Multivalent
Pneumococcal conjugate vaccine
Control
13vPnC
13vPnC
Pneumococcal conjugate vaccine
Interventions
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Multivalent
Pneumococcal conjugate vaccine
13vPnC
Pneumococcal conjugate vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study.
Exclusion Criteria
* Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
* Previous receipt of \>1 dose of hepatitis B vaccine.
* Prior hepatitis B vaccine must have been administered at age \<30 days.
* Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins
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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Northwest Arkansas Pediatrics
Fayetteville, Arkansas, United States
Premier Health Research Center, LLC
Downey, California, United States
St. Joseph Heritage Healthcare
Huntington Beach, California, United States
Kaiser Permanente Oakland
Oakland, California, United States
Orange County Research Institute
Ontario, California, United States
Kaiser Permanente South Sacramento
Sacramento, California, United States
Kaiser Permanente San Jose
San Jose, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
ACC Pediatric Research
Haughton, Louisiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
LSUHSC Shreveport
Shreveport, Louisiana, United States
University Health Shreveport
Shreveport, Louisiana, United States
Children's Physicians, Creighton University Medical Center
Omaha, Nebraska, United States
Child Health Care Associates
East Syracuse, New York, United States
Blue Ridge Pediatric and Adolescent Medicine, Inc.
Boone, North Carolina, United States
Capitol Pediatrics & Adolescent Center PLLC
Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Pediatric Associates of Mt. Carmel, Inc.
Cincinnati, Ohio, United States
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Oklahoma State University - Center for Health Sciences
Tulsa, Oklahoma, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
CCP - Kid's Way
Hermitage, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
Tekton Research, Inc.
San Antonio, Texas, United States
Wee Care Pediatrics
Layton, Utah, United States
Wasatch Pediatrics, Cottonwood Office
Murray, Utah, United States
Wee Care Pediatrics
Roy, Utah, United States
CopperView Medical Center
South Jordan, 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
Countries
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References
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Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7471003
Identifier Type: -
Identifier Source: org_study_id
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