20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
NCT ID: NCT04379713
Last Updated: 2023-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1511 participants
INTERVENTIONAL
2020-05-21
2022-08-31
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
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Interventions
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20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
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.
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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Eclipse Clinical Research
Tucson, Arizona, United States
Good Samaritan Family Health Team
Fullerton, California, United States
FocilMed
Oxnard, California, United States
Superior Research, LLC
Sacramento, California, United States
Carey Chronis, MD
Ventura, California, United States
Fomat - Robert Nudelman MD
Westlake Village, California, United States
Ebert Family Clinic
Frisco, Colorado, United States
Advanced Research for Health Improvement, LLC
Fort Myers, Florida, United States
Pensacola Pediatrics
Gulf Breeze, Florida, United States
Y&L Advance Health Care Inc, d/b/a Elite
Miami, Florida, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, United States
Citadelle Clinical Research
North Miami Beach, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Pensacola Pediatrics
Pensacola, Florida, United States
KIDZ Medical Services Pediatric Pulmonary Center
South Miami, Florida, United States
Teena Hughes/PAS Research
Tampa, Florida, United States
Idaho Falls Pediatrics
Ammon, Idaho, United States
Elite Clinical Trials LLLP
Blackfoot, Idaho, United States
Idaho Falls Pediatrics
Idaho Falls, Idaho, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
The Pediatric Center
Idaho Falls, Idaho, United States
Cotton O'Neil Clinical Research Center, Pediatrics
Topeka, Kansas, United States
All Children Pediatrics
Louisville, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
MedClinical Research Partners, LLC
East Orange, New Jersey, United States
Advantage Clinical Trials
The Bronx, New York, United States
Pediatric Partners, PA
Raleigh, North Carolina, United States
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
Statesville, North Carolina, United States
Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
Winston-Salem, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Advent Health Family Medicine Rural Health Clinics, Inc.
Lampasas, Texas, United States
FMC Science
Lampasas, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
Rio Grande Valley Clinical Research Institute
Pharr, Texas, United States
Tanner Clinic
Layton, Utah, United States
Wasatch Pediatrics - St. Marks Office
Salt Lake City, Utah, United States
CopperView Medical Center
South Jordan, Utah, United States
PI-Coor Clinical Research LLC
Burke, Virginia, United States
Clinica Mayo UMCB S.R.L.
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital del Nino Jesus
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Medico Dra. De Salvo
Buenos Aires, , Argentina
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Dawson Clinical Research Inc.
Guelph, Ontario, Canada
Milestone Research , Inc
London, Ontario, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, Canada
Dr. Hartley Garfield Medicine Professional Corporation
Toronto, Ontario, Canada
Centre hospitalier universitaire (CHU) Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Centre, Vaccine Study Centre
Pierrefonds, Quebec, Canada
CHU de Quebec-Universite Laval
Québec, Quebec, Canada
CESFAM Colina
Colina, Santiago, Santiago Metropolitan, Chile
CESFAM Esmeralda
Colina, Santiago, Santiago Metropolitan, Chile
Biocinetic
Santiago, Santiago Metropolitan, Chile
Grupo Estudios Clínicos Infectología Respiratoria
Santiago, Santiago Metropolitan, Chile
Hospital Padre Hurtado
Santiago, Santiago Metropolitan, Chile
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec II, , Czechia
Detska ambulance Petriny spol. s r.o.
Veleslavín, , Czechia
MeVac - Meilahti Vaccine Research Center
Helsinki, , Finland
SIBAmed GmbH & Co.KG
Leipzig, Saxony, Germany
Kinderarztpraxis Bramsche
Bramsche, , Germany
Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
Herford, , Germany
Praxis fuer Kinderpneumologie und Allergologie Mannheim
Mannheim, , Germany
Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
Mönchengladbach, , Germany
Praxis Dr. med. Joachim Weimer
Reinfeld, , Germany
University General Hospital of Heraklion
Heraklion, Crete, Greece
General University Hospital of Larissa
Larissa, Thessaly, Greece
"Aghia Sophia" Children's Hospital
Athens, , Greece
P. and A. Kyriakou Children's Hospital
Athens, , Greece
University General Hospital "ATTIKON"
Athens, , Greece
"Ippokratio" General Hospital of Thessaloniki
Thessaloniki, , Greece
Papp és Tsa Eü és Szolg Bt
Szigetvár, Baranya, Hungary
Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
Szombathely, Vas County, Hungary
Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
Budapest, , Hungary
Futurenest Kft. Pestszentimrei Gyermekrendelő
Budapest, , Hungary
Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
Csongrád, , Hungary
Futurenest Kft. 16. házi gyermekorvosi rendelő
Debrecen, , Hungary
Mimiped Bt
Győr, , Hungary
Futurenest Kft
Miskolc, , Hungary
Bettimedical BT
Százhalombatta, , Hungary
Ponce Medical School Foundation Inc./ CAIMED Center
Ponce, , Puerto Rico
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruna, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Centro de Salud de Burriana II
Burriana, Castellon, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Centro de Salud L'Eliana
L'Eliana, Valencia, Spain
Centro de Salud de Paiporta
Paiporta, Valencia, Spain
Clinica Corachan
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Grupo Pediatrico Uncibay
Málaga, , Spain
Centro de Salud de Malvarrosa
Valencia, , Spain
FISABIO
Valencia, , Spain
Centro de Salud la Serreria II
Valencia, , Spain
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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2019-003307-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471013
Identifier Type: -
Identifier Source: org_study_id
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