Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
NCT ID: NCT03550313
Last Updated: 2021-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
565 participants
INTERVENTIONAL
2018-06-01
2020-11-05
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
NONE
Study Groups
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Group 1 - Coadministration
Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13
Multivalent
Pneumococcal conjugate vaccine
Prevnar 13
Pneumococcal conjugate vaccine
Group 2 - Staggered Administration
Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13
Multivalent
Pneumococcal conjugate vaccine
Prevnar 13
Pneumococcal conjugate vaccine
Group 3 - Control with Supplemental Dose
Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine
Multivalent
Pneumococcal conjugate vaccine
Prevnar 13
Pneumococcal conjugate vaccine
Interventions
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Multivalent
Pneumococcal conjugate vaccine
Prevnar 13
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.
Exclusion Criteria
* Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
* 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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Mobile Pediatric Clinic
Mobile, Alabama, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Emmaus Research Center, Inc.
Anaheim, California, United States
Hoag Memorial Hospital Presbyterian
Huntington Beach, California, United States
Madera Family Medical Group
Madera, California, United States
Orange County Research Institute
Ontario, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Center for Clinical Trials
Paramount, California, United States
Gentle Medicine Associates
Boynton Beach, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Next Phase Research Alliance
Homestead, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Bio-Medical Research, LLC
Miami, Florida, United States
Crystal Biomedical Research, LLC
Miami Lakes, Florida, United States
IACT Health
Columbus, Georgia, United States
Advocate Children's Hospital
Park Ridge, Illinois, United States
MOC Research
Mishawaka, Indiana, United States
Michael W. Simon, MD, PSC
Lexington, Kentucky, United States
All Children Pediatrics
Louisville, Kentucky, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
LSUHSC-Shreveport
Shreveport, Louisiana, United States
Ochsner-LSU Health Shreveport
Shreveport, Louisiana, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States
Pediatric Phlebotomy
Boston, Massachusetts, United States
Tufts Medical Center IDS - Pharmacy
Boston, Massachusetts, United States
Children's Mercy Clinics on Broadway
Kansas City, Missouri, United States
Children's Physicians Embassy Park
Omaha, Nebraska, United States
Children's Physicians Spring Valley
Omaha, Nebraska, United States
Creighton University Clinical Research Office
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
Sugarcamp Family Research
Dayton, Ohio, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Parkside Pediatrics
Greenville, South Carolina, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
Sanford Research
Sioux Falls, South Dakota, United States
Sanford 69th & Louise Family Medicine
Sioux Falls, South Dakota, United States
Holston Medical Group
Kingsport, Tennessee, United States
Ventavia Research Group
Houston, Texas, United States
Mercury Clinical Research
Houston, Texas, United States
Pediatric Associates
Houston, Texas, United States
Ventavia Research Group
Keller, Texas, United States
Tekton Research, Inc.
San Antonio, Texas, United States
Ventavia Research Group, LLC
Spring, Texas, United States
Dixie Pediatrics
St. George, Utah, United States
Marshall Health
Huntington, West Virginia, United States
Countries
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References
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Simon MW, Bataille R, Caldwell NS, Gessner BD, Jodar L, Lamberth E, Peng Y, Scott DA, Lei L, Giardina PC, Gruber WC, Jansen KU, Thompson A, Watson W. Safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with 13-valent pneumococcal conjugate vaccine in healthy infants: A phase 2 randomized trial. Hum Vaccin Immunother. 2023 Aug;19(2):2245727. doi: 10.1080/21645515.2023.2245727. Epub 2023 Nov 5.
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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2020-005039-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3571002
Identifier Type: -
Identifier Source: org_study_id