20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

NCT ID: NCT04379713

Last Updated: 2023-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2022-08-31

Brief Summary

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

Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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20-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

20-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Group Type ACTIVE_COMPARATOR

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Pneumococcal conjugate vaccine

Interventions

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20-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

42 Days

Maximum Eligible Age

98 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Good Samaritan Family Health Team

Fullerton, California, United States

Site Status

FocilMed

Oxnard, California, United States

Site Status

Superior Research, LLC

Sacramento, California, United States

Site Status

Carey Chronis, MD

Ventura, California, United States

Site Status

Fomat - Robert Nudelman MD

Westlake Village, California, United States

Site Status

Ebert Family Clinic

Frisco, Colorado, United States

Site Status

Advanced Research for Health Improvement, LLC

Fort Myers, Florida, United States

Site Status

Pensacola Pediatrics

Gulf Breeze, Florida, United States

Site Status

Y&L Advance Health Care Inc, d/b/a Elite

Miami, Florida, United States

Site Status

Advanced Research for Health Improvement, LLC

Naples, Florida, United States

Site Status

Citadelle Clinical Research

North Miami Beach, Florida, United States

Site Status

Avanza Medical Research Center

Pensacola, Florida, United States

Site Status

Pensacola Pediatrics

Pensacola, Florida, United States

Site Status

KIDZ Medical Services Pediatric Pulmonary Center

South Miami, Florida, United States

Site Status

Teena Hughes/PAS Research

Tampa, Florida, United States

Site Status

Idaho Falls Pediatrics

Ammon, Idaho, United States

Site Status

Elite Clinical Trials LLLP

Blackfoot, Idaho, United States

Site Status

Idaho Falls Pediatrics

Idaho Falls, Idaho, United States

Site Status

Clinical Research Prime

Idaho Falls, Idaho, United States

Site Status

The Pediatric Center

Idaho Falls, Idaho, United States

Site Status

Cotton O'Neil Clinical Research Center, Pediatrics

Topeka, Kansas, United States

Site Status

All Children Pediatrics

Louisville, Kentucky, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

MedClinical Research Partners, LLC

East Orange, New Jersey, United States

Site Status

Advantage Clinical Trials

The Bronx, New York, United States

Site Status

Pediatric Partners, PA

Raleigh, North Carolina, United States

Site Status

PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare

Statesville, North Carolina, United States

Site Status

Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)

Winston-Salem, North Carolina, United States

Site Status

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Coastal Pediatric Research

Summerville, South Carolina, United States

Site Status

The Jackson Clinic, PA

Jackson, Tennessee, United States

Site Status

Advent Health Family Medicine Rural Health Clinics, Inc.

Lampasas, Texas, United States

Site Status

FMC Science

Lampasas, Texas, United States

Site Status

Maximos Ob/Gyn

League City, Texas, United States

Site Status

Rio Grande Valley Clinical Research Institute

Pharr, Texas, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Wasatch Pediatrics - St. Marks Office

Salt Lake City, Utah, United States

Site Status

CopperView Medical Center

South Jordan, Utah, United States

Site Status

PI-Coor Clinical Research LLC

Burke, Virginia, United States

Site Status

Clinica Mayo UMCB S.R.L.

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

Hospital del Nino Jesus

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

Centro Medico Dra. De Salvo

Buenos Aires, , Argentina

Site Status

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Site Status

Dawson Clinical Research Inc.

Guelph, Ontario, Canada

Site Status

Milestone Research , Inc

London, Ontario, Canada

Site Status

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Site Status

Dr. Hartley Garfield Medicine Professional Corporation

Toronto, Ontario, Canada

Site Status

Centre hospitalier universitaire (CHU) Sainte-Justine

Montreal, Quebec, Canada

Site Status

McGill University Health Centre, Vaccine Study Centre

Pierrefonds, Quebec, Canada

Site Status

CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Site Status

CESFAM Colina

Colina, Santiago, Santiago Metropolitan, Chile

Site Status

CESFAM Esmeralda

Colina, Santiago, Santiago Metropolitan, Chile

Site Status

Biocinetic

Santiago, Santiago Metropolitan, Chile

Site Status

Grupo Estudios Clínicos Infectología Respiratoria

Santiago, Santiago Metropolitan, Chile

Site Status

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, Chile

Site Status

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, , Czechia

Site Status

Ordinace praktickeho lekare pro deti a dorost

Jindrichuv Hradec II, , Czechia

Site Status

Detska ambulance Petriny spol. s r.o.

Veleslavín, , Czechia

Site Status

MeVac - Meilahti Vaccine Research Center

Helsinki, , Finland

Site Status

SIBAmed GmbH & Co.KG

Leipzig, Saxony, Germany

Site Status

Kinderarztpraxis Bramsche

Bramsche, , Germany

Site Status

Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel

Herford, , Germany

Site Status

Praxis fuer Kinderpneumologie und Allergologie Mannheim

Mannheim, , Germany

Site Status

Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott

Mönchengladbach, , Germany

Site Status

Praxis Dr. med. Joachim Weimer

Reinfeld, , Germany

Site Status

University General Hospital of Heraklion

Heraklion, Crete, Greece

Site Status

General University Hospital of Larissa

Larissa, Thessaly, Greece

Site Status

"Aghia Sophia" Children's Hospital

Athens, , Greece

Site Status

P. and A. Kyriakou Children's Hospital

Athens, , Greece

Site Status

University General Hospital "ATTIKON"

Athens, , Greece

Site Status

"Ippokratio" General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status

Papp és Tsa Eü és Szolg Bt

Szigetvár, Baranya, Hungary

Site Status

Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely

Szombathely, Vas County, Hungary

Site Status

Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő

Budapest, , Hungary

Site Status

Futurenest Kft. Pestszentimrei Gyermekrendelő

Budapest, , Hungary

Site Status

Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis

Csongrád, , Hungary

Site Status

Futurenest Kft. 16. házi gyermekorvosi rendelő

Debrecen, , Hungary

Site Status

Mimiped Bt

Győr, , Hungary

Site Status

Futurenest Kft

Miskolc, , Hungary

Site Status

Bettimedical BT

Százhalombatta, , Hungary

Site Status

Ponce Medical School Foundation Inc./ CAIMED Center

Ponce, , Puerto Rico

Site Status

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruna, Spain

Site Status

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Centro de Salud de Burriana II

Burriana, Castellon, Spain

Site Status

Hospital Universitario de Burgos

Burgos, Castille and León, Spain

Site Status

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain

Site Status

Centro de Salud L'Eliana

L'Eliana, Valencia, Spain

Site Status

Centro de Salud de Paiporta

Paiporta, Valencia, Spain

Site Status

Clinica Corachan

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Grupo Pediatrico Uncibay

Málaga, , Spain

Site Status

Centro de Salud de Malvarrosa

Valencia, , Spain

Site Status

FISABIO

Valencia, , Spain

Site Status

Centro de Salud la Serreria II

Valencia, , Spain

Site Status

Countries

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United States Argentina Canada Chile Czechia Finland Germany Greece Hungary Puerto Rico Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7471013

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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