Clinical trial NCT04379713: 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 1511
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.


Eligibility criteria: Inclusion Criteria:

* Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42 to ≤98 days) at the time of consent (the day of birth is considered day of life 1).
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
* Major known congenital malformation or serious chronic disorder.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1
timeFrame: Within 7 Days after Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2
timeFrame: Within 7 Days after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 Days after Dose 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 4
timeFrame: Within 7 Days after Dose 4
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1
timeFrame: Within 7 Days after Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 Days after Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 Days after Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 4
timeFrame: Within 7 Days after Dose 4
measure: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
timeFrame: From Dose 1 to 1 Month after Dose 3
measure: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
timeFrame: From Dose 4 to 1 Month after Dose 4
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4
timeFrame: From Dose 1 to 6 Months after Dose 4
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4
timeFrame: From Dose 1 to 6 Months after Dose 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Fullerton
country: United States
facility: Good Samaritan Family Health Team
state: California
city: Oxnard
country: United States
facility: FocilMed
state: California
city: Sacramento
country: United States
facility: Superior Research, LLC
state: California
city: Ventura
country: United States
facility: Carey Chronis, MD
state: California
city: Westlake Village
country: United States
facility: Fomat - Robert Nudelman MD
state: California
city: Frisco
country: United States
facility: Ebert Family Clinic
state: Colorado
city: Fort Myers
country: United States
facility: Advanced Research for Health Improvement, LLC
state: Florida
city: Gulf Breeze
country: United States
facility: Pensacola Pediatrics
state: Florida
city: Miami
country: United States
facility: Y&L Advance Health Care Inc, d/b/a Elite
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Citadelle Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Pensacola
country: United States
facility: Pensacola Pediatrics
state: Florida
city: South Miami
country: United States
facility: KIDZ Medical Services Pediatric Pulmonary Center
state: Florida
city: Tampa
country: United States
facility: Teena Hughes/PAS Research
state: Florida
city: Ammon
country: United States
facility: Idaho Falls Pediatrics
state: Idaho
city: Blackfoot
country: United States
facility: Elite Clinical Trials LLLP
state: Idaho
city: Idaho Falls
country: United States
facility: Idaho Falls Pediatrics
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: The Pediatric Center
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center, Pediatrics
state: Kansas
city: Louisville
country: United States
facility: All Children Pediatrics
state: Kentucky
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: East Orange
country: United States
facility: MedClinical Research Partners, LLC
state: New Jersey
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Raleigh
country: United States
facility: Pediatric Partners, PA
state: North Carolina
city: Statesville
country: United States
facility: PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
state: North Carolina
city: Winston-Salem
country: United States
facility: Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Lampasas
country: United States
facility: Advent Health Family Medicine Rural Health Clinics, Inc.
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: Pharr
country: United States
facility: Rio Grande Valley Clinical Research Institute
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Pediatrics - St. Marks Office
state: Utah
city: South Jordan
country: United States
facility: CopperView Medical Center
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research LLC
state: Virginia
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo UMCB S.R.L.
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Hospital del Nino Jesus
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra. De Salvo
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Guelph
country: Canada
facility: Dawson Clinical Research Inc.
state: Ontario
city: London
country: Canada
facility: Milestone Research , Inc
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Hartley Garfield Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier universitaire (CHU) Sainte-Justine
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre, Vaccine Study Centre
state: Quebec
city: Québec City
country: Canada
facility: CHU de Quebec-Universite Laval
state: Quebec
city: Colina, Santiago
country: Chile
facility: CESFAM Colina
state: Región Metropolitana
city: Colina, Santiago
country: Chile
facility: CESFAM Esmeralda
state: Región Metropolitana
city: Santiago
country: Chile
facility: Biocinetic
state: Región Metropolitana
city: Santiago
country: Chile
facility: Grupo Estudios Clínicos Infectología Respiratoria
state: Región Metropolitana
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
state: Región Metropolitana
city: Hradec Kralove
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Jindrichuv Hradec II
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Veleslavin
country: Czechia
facility: Detska ambulance Petriny spol. s r.o.
city: Helsinki
country: Finland
facility: MeVac - Meilahti Vaccine Research Center
city: Leipzig
country: Germany
facility: SIBAmed GmbH & Co.KG
state: Saxony
city: Bramsche
country: Germany
facility: Kinderarztpraxis Bramsche
city: Herford
country: Germany
facility: Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
city: Mannheim
country: Germany
facility: Praxis fuer Kinderpneumologie und Allergologie Mannheim
city: Mönchengladbach
country: Germany
facility: Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
city: Reinfeld
country: Germany
facility: Praxis Dr. med. Joachim Weimer
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Crete
city: Larissa
country: Greece
facility: General University Hospital of Larissa
state: Thessaly
city: Athens
country: Greece
facility: "Aghia Sophia" Children's Hospital
city: Athens
country: Greece
facility: P. and A. Kyriakou Children's Hospital
city: Athens
country: Greece
facility: University General Hospital "ATTIKON"
city: Thessaloniki
country: Greece
facility: "Ippokratio" General Hospital of Thessaloniki
city: Szigetvar
country: Hungary
facility: Papp és Tsa Eü és Szolg Bt
state: Baranya
city: Szombathely
country: Hungary
facility: Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
state: VAS Megye
city: Budapest
country: Hungary
facility: Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
city: Budapest
country: Hungary
facility: Futurenest Kft. Pestszentimrei Gyermekrendelő
city: Csongrad
country: Hungary
facility: Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
city: Debrecen
country: Hungary
facility: Futurenest Kft. 16. házi gyermekorvosi rendelő
city: Gyor
country: Hungary
facility: Mimiped Bt
city: Miskolc
country: Hungary
facility: Futurenest Kft
city: Szazhalombatta
country: Hungary
facility: Bettimedical BT
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc./ CAIMED Center
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruna
city: Sant Cugat del Valles
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona
city: Burriana
country: Spain
facility: Centro de Salud de Burriana II
state: Castellon
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla Y LEON
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Monteprincipe
state: Madrid
city: L'Eliana
country: Spain
facility: Centro de Salud L'Eliana
state: Valencia
city: Paiporta
country: Spain
facility: Centro de Salud de Paiporta
state: Valencia
city: Barcelona
country: Spain
facility: Clinica Corachan
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Grupo Pediatrico Uncibay
city: Valencia
country: Spain
facility: Centro de Salud de Malvarrosa
city: Valencia
country: Spain
facility: FISABIO
city: Valencia
country: Spain
facility: Centro de Salud la Serreria II
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: