20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

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

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 1511
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Centro Médico Dra. De Salvo
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Clinica Mayo UMCB S.R.L.
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Hospital del Niño Jesus
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
    • Guelph, Ontario, Canada, N1H 1B1
      • Dawson Clinical Research Inc.
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research , Inc
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
    • Toronto, Ontario, Canada, M5G 1N8
      • Dr. Hartley Garfield Medicine Professional Corporation
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Centre Hospitalier Universitaire (CHU) Sainte-Justine
    • Pierrefonds, Quebec, Canada, H9H 4Y6
      • McGill University Health Centre, Vaccine Study Centre
    • Québec City, Quebec, Canada, G1E 7G9
      • CHU de Quebec-Universite Laval
• Chile
  • Región Metropolitana
    • Colina, Santiago, Región Metropolitana, Chile, 9350079
      • CESFAM Colina
    • Colina, Santiago, Región Metropolitana, Chile
      • CESFAM Esmeralda
    • Santiago, Región Metropolitana, Chile, 8380453
      • Grupo Estudios Clínicos Infectología Respiratoria
    • Santiago, Región Metropolitana, Chile, 8880465
      • Hospital Padre Hurtado
    • Santiago, Región Metropolitana, Chile, 8331143
      • Biocinetic
• Czechia
  • Hradec Kralove, Czechia, 50004
    • Ordinace praktického lékaře pro děti a dorost
  • Jindrichuv Hradec II, Czechia, 377 01
    • Ordinace praktického lékaře pro děti a dorost
  • Veleslavin, Czechia, 162 00
    • Detska ambulance Petriny spol. s r.o.
• Finland
  • Helsinki, Finland, 00290
    • MeVac - Meilahti Vaccine Research Center
• Germany
  • Bramsche, Germany, 49565
    • Kinderarztpraxis Bramsche
  • Herford, Germany, 32049
    • Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
  • Mannheim, Germany, 68161
    • Praxis fuer Kinderpneumologie und Allergologie Mannheim
  • Mönchengladbach, Germany, 41236
    • Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
  • Reinfeld, Germany, 23858
    • Praxis Dr. med. Joachim Weimer
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Sibamed GmbH & Co.KG
• Greece
  • Athens, Greece, 12462
    • University General Hospital "Attikon"
  • Athens, Greece, 11527
    • "Aghia Sophia" Children's Hospital
  • Athens, Greece, 11527
    • P. and A. Kyriakou Children's Hospital
  • Thessaloniki, Greece, 54642
    • "Ippokratio" General Hospital of Thessaloniki
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • General University Hospital Of Larissa
• Hungary
  • Budapest, Hungary, 1042
    • Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
  • Budapest, Hungary, 1188
    • Futurenest Kft. Pestszentimrei Gyermekrendelő
  • Csongrad, Hungary, 6640
    • Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
  • Debrecen, Hungary, 4025
    • Futurenest Kft. 16. házi gyermekorvosi rendelő
  • Gyor, Hungary, 9024
    • Mimiped Bt
  • Miskolc, Hungary, 3527
    • Futurenest Kft
  • Szazhalombatta, Hungary, 2440
    • Bettimedical BT
  • Baranya
    • Szigetvar, Baranya, Hungary, 7900
      • Papp és Tsa Eü és Szolg Bt
  • VAS Megye
    • Szombathely, VAS Megye, Hungary, 9700
      • Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
• Puerto Rico
  • Ponce, Puerto Rico, 00176
    • Ponce Medical School Foundation Inc./ CAIMED Center
• Spain
  • Barcelona, Spain, 08017
    • Clínica Corachan
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Malaga, Spain, 29015
    • Grupo Pediatrico Uncibay
  • Valencia, Spain, 46020
    • FISABIO
  • Valencia, Spain, 46022
    • Centro de Salud la Serreria II
  • Valencia, Spain, 46011
    • Centro de Salud de Malvarrosa
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • CHUS - Hospital Clinico Universitario
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 08195
      • Hospital Universitari General de Catalunya
  • Castellon
    • Burriana, Castellon, Spain, 12530
      • Centro de Salud de Burriana II
  • Castilla Y LEON
    • Burgos, Castilla Y LEON, Spain, 09006
      • Hospital Universitario de Burgos
  • Madrid
    • Boadilla del Monte, Madrid, Spain, 28660
      • Hospital Universitario HM Monteprincipe
  • Valencia
    • L'Eliana, Valencia, Spain, 46183
      • Centro de Salud L'Eliana
    • Paiporta, Valencia, Spain, 46200
      • Centro de Salud de Paiporta
• United States
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • California
    • Fullerton, California, United States, 92831
      • Good Samaritan Family Health Team
    • Oxnard, California, United States, 93030
      • FocilMed
    • Sacramento, California, United States, 95831
      • Superior Research, LLC
    • Ventura, California, United States, 93003
      • Carey Chronis, MD
    • Westlake Village, California, United States, 91361
      • Fomat - Robert Nudelman MD
  • Colorado
    • Frisco, Colorado, United States, 80443
      • Ebert Family Clinic
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Advanced Research for Health Improvement, LLC
    • Gulf Breeze, Florida, United States, 32563
      • Pensacola Pediatrics
    • Miami, Florida, United States, 33144
      • Y&L Advance Health Care Inc, d/b/a Elite
    • Naples, Florida, United States, 34102
      • Advanced Research for Health Improvement, LLC
    • North Miami Beach, Florida, United States, 33162
      • Citadelle Clinical Research
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
    • Pensacola, Florida, United States, 32504
      • Pensacola Pediatrics
    • South Miami, Florida, United States, 33143
      • KIDZ Medical Services Pediatric Pulmonary Center
    • Tampa, Florida, United States, 33613
      • Teena Hughes/PAS Research
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Idaho Falls Pediatrics
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials LLLP
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
    • Idaho Falls, Idaho, United States, 83404
      • The Pediatric Center
    • Idaho Falls, Idaho, United States, 83402
      • Idaho Falls Pediatrics
  • Kansas
    • Topeka, Kansas, United States, 66604
      • Cotton O'Neil Clinical Research Center, Pediatrics
  • Kentucky
    • Louisville, Kentucky, United States, 40243
      • All Children Pediatrics
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • MedClinical Research Partners, LLC
  • New York
    • Bronx, New York, United States, 10468
      • Advantage Clinical Trials
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Pediatric Partners, PA
    • Statesville, North Carolina, United States, 28625
      • PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
    • Winston-Salem, North Carolina, United States, 27103
      • Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
  • Texas
    • Lampasas, Texas, United States, 76550
      • FMC Science
    • Lampasas, Texas, United States, 76550
      • Advent Health Family Medicine Rural Health Clinics, Inc.
    • League City, Texas, United States, 77573
      • Maximos Ob/Gyn
    • Pharr, Texas, United States, 78577
      • Rio Grande Valley Clinical Research Institute
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • Salt Lake City, Utah, United States, 84124
      • Wasatch Pediatrics - St. Marks Office
    • South Jordan, Utah, United States, 84095
      • Copperview Medical Center
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine	Biological: 20-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine	Biological: 13-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Local Reactions Within 7 Days After Dose 1	Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.	Within 7 Days after Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2	Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.	Within 7 Days after Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3	Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.	Within 7 Days after Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4	Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement.	Within 7 Days after Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Dose 1	Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days after Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2	Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days after Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3	Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days after Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4	Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days after Dose 4
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	From Dose 1 to 1 Month after Dose 3
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	From Dose 4 to 1 Month after Dose 4
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4	A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events.	From Dose 1 to 6 Months after Dose 4
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4	An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.	From Dose 1 to 6 Months after Dose 4

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B7471013; 2019-003307-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No