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20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

42 Days - 98 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eclipse Clinical Research
  • Good Samaritan Family Health Team
  • FocilMed
  • Superior Research, LLC
  • Carey Chronis, MD
  • Fomat - Robert Nudelman MD
  • Ebert Family Clinic
  • Advanced Research for Health Improvement, LLC
  • Pensacola Pediatrics
  • Y&L Advance Health Care Inc, d/b/a Elite
  • Advanced Research for Health Improvement, LLC
  • Citadelle Clinical Research
  • Avanza Medical Research Center
  • Pensacola Pediatrics
  • KIDZ Medical Services Pediatric Pulmonary Center
  • Teena Hughes/PAS Research
  • Idaho Falls Pediatrics
  • Elite Clinical Trials LLLP
  • Idaho Falls Pediatrics
  • Clinical Research Prime
  • The Pediatric Center
  • Cotton O'Neil Clinical Research Center, Pediatrics
  • All Children Pediatrics
  • Boston Medical Center
  • MedClinical Research Partners, LLC
  • Advantage Clinical Trials
  • Pediatric Partners, PA
  • PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
  • Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network)
  • PMG Research of Winston-Salem
  • Omega Medical Research
  • Coastal Pediatric Research
  • The Jackson Clinic, PA
  • Advent Health Family Medicine Rural Health Clinics, Inc.
  • FMC Science
  • Maximos Ob/Gyn
  • Rio Grande Valley Clinical Research Institute
  • Tanner Clinic
  • Wasatch Pediatrics - St. Marks Office
  • CopperView Medical Center
  • PI-Coor Clinical Research LLC
  • Clinica Mayo UMCB S.R.L.
  • Hospital del Nino Jesus
  • Centro Medico Dra. De Salvo
  • Aggarwal and Associates Limited
  • Dawson Clinical Research Inc.
  • Milestone Research , Inc
  • Bluewater Clinical Research Group Inc.
  • Dr. Hartley Garfield Medicine Professional Corporation
  • Centre hospitalier universitaire (CHU) Sainte-Justine
  • McGill University Health Centre, Vaccine Study Centre
  • CHU de Quebec-Universite Laval
  • CESFAM Colina
  • CESFAM Esmeralda
  • Biocinetic
  • Grupo Estudios Clínicos Infectología Respiratoria
  • Hospital Padre Hurtado
  • Ordinace praktickeho lekare pro deti a dorost
  • Ordinace praktickeho lekare pro deti a dorost
  • Detska ambulance Petriny spol. s r.o.
  • MeVac - Meilahti Vaccine Research Center
  • SIBAmed GmbH & Co.KG
  • Kinderarztpraxis Bramsche
  • Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel
  • Praxis fuer Kinderpneumologie und Allergologie Mannheim
  • Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott
  • Praxis Dr. med. Joachim Weimer
  • University General Hospital of Heraklion
  • General University Hospital of Larissa
  • "Aghia Sophia" Children's Hospital
  • P. and A. Kyriakou Children's Hospital
  • University General Hospital "ATTIKON"
  • "Ippokratio" General Hospital of Thessaloniki
  • Papp és Tsa Eü és Szolg Bt
  • Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely
  • Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő
  • Futurenest Kft. Pestszentimrei Gyermekrendelő
  • Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis
  • Futurenest Kft. 16. házi gyermekorvosi rendelő
  • Mimiped Bt
  • Futurenest Kft
  • Bettimedical BT
  • Ponce Medical School Foundation Inc./ CAIMED Center
  • CHUS - Hospital Clinico Universitario
  • Hospital Universitari General de Catalunya
  • Centro de Salud de Burriana II
  • Hospital Universitario de Burgos
  • Hospital Universitario HM Monteprincipe
  • Centro de Salud L'Eliana
  • Centro de Salud de Paiporta
  • Clinica Corachan
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Grupo Pediatrico Uncibay
  • Centro de Salud de Malvarrosa
  • FISABIO
  • Centro de Salud la Serreria II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine

Arm Description

Pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2020
Last Updated
May 18, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04379713
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20-valent pneumococcal conjugate vaccine
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine
Arm Title
13-valent pneumococcal conjugate vaccine
Arm Type
Active Comparator
Arm Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
20-valent pneumococcal conjugate vaccine
Intervention Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
Pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Description
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.
Time Frame
Within 7 Days after Dose 1
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Description
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.
Time Frame
Within 7 Days after Dose 2
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Description
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.
Time Frame
Within 7 Days after Dose 3
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Description
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.
Time Frame
Within 7 Days after Dose 4
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Description
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).
Time Frame
Within 7 Days after Dose 1
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Description
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).
Time Frame
Within 7 Days after Dose 2
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Description
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).
Time Frame
Within 7 Days after Dose 3
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Description
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).
Time Frame
Within 7 Days after Dose 4
Title
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Description
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.
Time Frame
From Dose 1 to 1 Month after Dose 3
Title
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
Description
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.
Time Frame
From Dose 4 to 1 Month after Dose 4
Title
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4
Description
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.
Time Frame
From Dose 1 to 6 Months after Dose 4
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4
Description
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.
Time Frame
From Dose 1 to 6 Months after Dose 4

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471013
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

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