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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series 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 >36 weeks of gestation and 2 months of age at the time of consent.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Major known congenital malformation or serious chronic disorder
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
  • Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation

Sites / Locations

  • Children's of Alabama
  • UAB Pediatric Primary Care Clinic at Children's of Alabama
  • Southeastern Pediatric Associates
  • MedPharmics, LLC
  • Northwest Arkansas Pediatrics
  • The Children's Clinic of Jonesboro, P.A.
  • Gardens Medical Center
  • Coast Clinical Research, LLC
  • Priti Desai, M.D. Inc.
  • Universal Biopharma Research Institute Inc.
  • Matrix Clinical Research
  • Advanced Investigative Medicine, Inc.
  • Kaiser Permanente Oakland
  • Orange County Research Institute
  • Center for Clinical Trials of San Gabriel
  • Children's Colorado Health Pavilion (Child Health Clinic)
  • Children's Hospital Colorado
  • Optumcare Colorado Springs, LLC
  • Optumcare Colorado Springs, LLC
  • Gentle Medicine Associates
  • Sarkis Clinical Trials
  • Benton Pediatrics
  • Qway Research
  • Next Phase Research Alliance
  • Axcess Medical Research
  • Crystal Biomedical Research, LLC
  • Acevedo Clinical Research Associates
  • Suncoast Research Associates, LLC
  • Bio-Medical Research, LLC
  • Children's Health Center
  • Tekton Research, Inc.
  • Uptown Pediatrics
  • Columbus Regional Research Institute
  • Meridian Clinical Research
  • Omega Pediatrics
  • Idaho Falls Pediatrics
  • Idaho Falls Pediatrics
  • Clinical Research Prime
  • Family First Medical Center
  • Snake River Research, PLLC
  • The Pediatric Center
  • Saltzer Health
  • ASR, LLC
  • The Iowa Clinic
  • Blank Children's Pediatric Clinic
  • Unity Point Health
  • The Iowa Clinic
  • Alliance for Multispecialty Research, LLC
  • Kentucky Pediatric/Adult Research
  • Michael W. Simon, MD, PSC
  • Novak Center for Children's Health
  • Brownsboro Park Pediatrics
  • Meridian Clinical Research, LLC
  • Benchmark Research
  • ACC Pediatric Research
  • MedPharmics, LLC
  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health
  • The Pediatric Center of Frederick, LLC
  • MedPharmics, LLC
  • Boeson Research
  • Meridian Clinical Research
  • Midwest Children's Health Research Institute
  • Midwest Children's Health Research Institute
  • Children's Physicians Dundee
  • Medpharmics
  • SUNY Downstate Medical Center
  • Child Health Care Associates
  • Smart Medical Research, Inc
  • Child Health Care Associates
  • ECU Physicians Adult and Pediatric Health Center
  • ECU Physicians Pediatric Outpatient Clinic
  • Leo Jenkins Cancer Center Pharmacy
  • Dayton Clinical Research
  • Ohio Pediatric Research Association, Inc.
  • Pediatric Associates of Fairfield
  • Senders Pediatrics
  • Pediatric Medical Associates
  • Allegheny Health and Wellness Pavilion
  • Lockman & Lubell Pediatric Associates
  • Coastal Pediatric Research
  • Palmetto Pediatrics, PA
  • Sanford Children's Specialty Clinic
  • Sanford 69th & Louise Family Medicine
  • Holston Medical Group
  • Premier Medical Group
  • Holston Medical Group
  • LeBonheur Children's Hospital
  • Coastal Bend Clinical Research
  • Kool Kids Pediatrics
  • La Providence Pediatrics Clinic
  • Houston Clinical Research Associates
  • DCOL Center for Clinical Research
  • Diagnostic Clinic of Longview
  • Ashley Pediatrics Day and Night Clinic
  • Dr. Ruben Aleman & Associates
  • Tekton Research, Inc.
  • Wee Care Pediatrics
  • Wee Care Pediatrics
  • Wasatch Pediatrics, Cottonwood Office
  • Wee Care Pediatrics
  • Dixie Pediatrics
  • Wee Care Pediatrics
  • Pediatric Associates of Charlottesville, PLC
  • Pediatric Research of Charlottesville, LLC
  • The Vancouver Clinic, Inc
  • Cooperativa de Facultad Medica Sanacoop DBA Instituto Sanacoop
  • Clinical Research Puerto Rico
  • Hispanic Alliance for Clinical and Translational Research
  • San Juan Hospital
  • San Miguel Medical

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

The percentages of participants reporting prompted local reactions within 7 days after each vaccination in each group
Prompted local reactions after each dose in each group
The percentages of participants reporting prompted systemic events within 7 days after each vaccination in each group
Prompted systemic reactions after each dose in each group
The percentages of participants reporting AEs from Dose 1 to 1 month after Dose 3 in each group
Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group
The percentages of participants reporting AEs from Dose 4 to 1 month after Dose 4 in each group
Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group
The percentages of participants reporting SAEs up to 6 months after Dose 4 in each group
SAEs occurring up to 6 months after Dose 4 in each group
The percentages of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group
NDCMCs occurring up to 6 months after Dose 4 in each group
The percentages of participants with pre-defined pneumococcal IgG concentrations at 1 month after Dose 3
IgG concentrations 1 month after Dose 3
IgG GMCs 1 month after Dose 4
IgG GMCs 1 month after Dose 4
The percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
Antibody levels 1 month after Dose 3

Secondary Outcome Measures

IgG GMCs 1 month after Dose 3
IgG GMC concentrations 1 month after Dose 3
The percentages of participants with predefined pneumococcal IgG concentrations at 1 month after Dose 4
IgG concentrations 1 month after Dose 4
OPA GMTs at 1 month after Dose 3 in each group
OPA GMTs 1 month after Dose 3
OPA GMTs at 1 month after Dose 4 in each group
OPA GMTs 1 month after Dose 4
IgG GMFRs from 1 month after Dose 3 to before Dose 4
IgG GMFRs from 1 month after Dose 3 to before Dose 4
IgG GMFRs from 1 month before to 1 month after Dose 4
IgG GMFRs from 1 month before to 1 month after Dose 4
IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4
IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4
Percentages of participants with pre-specified antibody levels to specific concomitant vaccine antigen 1 month after Dose 3
Antibody levels 1 month after Dose 3
Ratios of antibody levels for specific concomitant vaccine antigens 1 month after Dose 4
Antibody levels 1 month after Dose 4

Full Information

First Posted
May 7, 2020
Last Updated
November 1, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04382326
Brief Title
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 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
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series 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
1997 (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
20-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
13-valent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
The percentages of participants reporting prompted local reactions within 7 days after each vaccination in each group
Description
Prompted local reactions after each dose in each group
Time Frame
Day 7
Title
The percentages of participants reporting prompted systemic events within 7 days after each vaccination in each group
Description
Prompted systemic reactions after each dose in each group
Time Frame
Day 7
Title
The percentages of participants reporting AEs from Dose 1 to 1 month after Dose 3 in each group
Description
Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group
Time Frame
Dose 1 to 1 month after Dose 3
Title
The percentages of participants reporting AEs from Dose 4 to 1 month after Dose 4 in each group
Description
Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group
Time Frame
Dose 4 to 1 month after Dose 4
Title
The percentages of participants reporting SAEs up to 6 months after Dose 4 in each group
Description
SAEs occurring up to 6 months after Dose 4 in each group
Time Frame
Dose 1 to 6 months after Dose 4
Title
The percentages of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group
Description
NDCMCs occurring up to 6 months after Dose 4 in each group
Time Frame
Dose 1 to 6 months after Dose 4
Title
The percentages of participants with pre-defined pneumococcal IgG concentrations at 1 month after Dose 3
Description
IgG concentrations 1 month after Dose 3
Time Frame
1 month after Dose 3
Title
IgG GMCs 1 month after Dose 4
Description
IgG GMCs 1 month after Dose 4
Time Frame
1 month after Dose 4
Title
The percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
Description
Antibody levels 1 month after Dose 3
Time Frame
1 month after Dose 3
Secondary Outcome Measure Information:
Title
IgG GMCs 1 month after Dose 3
Description
IgG GMC concentrations 1 month after Dose 3
Time Frame
1 month after Dose 3
Title
The percentages of participants with predefined pneumococcal IgG concentrations at 1 month after Dose 4
Description
IgG concentrations 1 month after Dose 4
Time Frame
1 month after Dose 4
Title
OPA GMTs at 1 month after Dose 3 in each group
Description
OPA GMTs 1 month after Dose 3
Time Frame
1 month after Dose 3
Title
OPA GMTs at 1 month after Dose 4 in each group
Description
OPA GMTs 1 month after Dose 4
Time Frame
1 month after Dose 4
Title
IgG GMFRs from 1 month after Dose 3 to before Dose 4
Description
IgG GMFRs from 1 month after Dose 3 to before Dose 4
Time Frame
From 1 month after Dose 3 to before Dose 4
Title
IgG GMFRs from 1 month before to 1 month after Dose 4
Description
IgG GMFRs from 1 month before to 1 month after Dose 4
Time Frame
From 1 month before to 1 month after Dose 4
Title
IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4
Description
IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4
Time Frame
From 1 month after Dose 3 to 1 month after Dose 4
Title
Percentages of participants with pre-specified antibody levels to specific concomitant vaccine antigen 1 month after Dose 3
Description
Antibody levels 1 month after Dose 3
Time Frame
1 month after Dose 3
Title
Ratios of antibody levels for specific concomitant vaccine antigens 1 month after Dose 4
Description
Antibody levels 1 month after Dose 4
Time Frame
1 month 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 >36 weeks of gestation and 2 months of age at the time of consent. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. Exclusion Criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) Major known congenital malformation or serious chronic disorder Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
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
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UAB Pediatric Primary Care Clinic at Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Southeastern Pediatric Associates
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
MedPharmics, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Northwest Arkansas Pediatrics
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
The Children's Clinic of Jonesboro, P.A.
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Gardens Medical Center
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Coast Clinical Research, LLC
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Priti Desai, M.D. Inc.
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Universal Biopharma Research Institute Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
Matrix Clinical Research
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
Advanced Investigative Medicine, Inc.
City
Hawthorne
State/Province
California
ZIP/Postal Code
90250
Country
United States
Facility Name
Kaiser Permanente Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Orange County Research Institute
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Center for Clinical Trials of San Gabriel
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Children's Colorado Health Pavilion (Child Health Clinic)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80011
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Optumcare Colorado Springs, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Optumcare Colorado Springs, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
Facility Name
Gentle Medicine Associates
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Benton Pediatrics
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32653
Country
United States
Facility Name
Qway Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Next Phase Research Alliance
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Crystal Biomedical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Bio-Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
Children's Health Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Tekton Research, Inc.
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Uptown Pediatrics
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Meridian Clinical Research
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Omega Pediatrics
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Idaho Falls Pediatrics
City
Ammon
State/Province
Idaho
ZIP/Postal Code
83406
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
Family First Medical Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Snake River Research, PLLC
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
Saltzer Health
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
ASR, LLC
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
The Iowa Clinic
City
Ankeny
State/Province
Iowa
ZIP/Postal Code
50023
Country
United States
Facility Name
Blank Children's Pediatric Clinic
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Unity Point Health
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
The Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Michael W. Simon, MD, PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
Novak Center for Children's Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Brownsboro Park Pediatrics
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Benchmark Research
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
ACC Pediatric Research
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The Pediatric Center of Frederick, LLC
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
MedPharmics, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Children's Physicians Dundee
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
Facility Name
Medpharmics
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Child Health Care Associates
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Smart Medical Research, Inc
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Facility Name
Child Health Care Associates
City
Liverpool
State/Province
New York
ZIP/Postal Code
13090
Country
United States
Facility Name
ECU Physicians Adult and Pediatric Health Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
ECU Physicians Pediatric Outpatient Clinic
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Leo Jenkins Cancer Center Pharmacy
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Ohio Pediatric Research Association, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Pediatric Associates of Fairfield
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Senders Pediatrics
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Pediatric Medical Associates
City
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Lockman & Lubell Pediatric Associates
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Palmetto Pediatrics, PA
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-9170
Country
United States
Facility Name
Sanford Children's Specialty Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford 69th & Louise Family Medicine
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Premier Medical Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
LeBonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Coastal Bend Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
Kool Kids Pediatrics
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
La Providence Pediatrics Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77071
Country
United States
Facility Name
Houston Clinical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Diagnostic Clinic of Longview
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Ashley Pediatrics Day and Night Clinic
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Dr. Ruben Aleman & Associates
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Tekton Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
Wee Care Pediatrics
City
Kaysville
State/Province
Utah
ZIP/Postal Code
84037
Country
United States
Facility Name
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wasatch Pediatrics, Cottonwood Office
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wee Care Pediatrics
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
Dixie Pediatrics
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Wee Care Pediatrics
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Pediatric Associates of Charlottesville, PLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
The Vancouver Clinic, Inc
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Cooperativa de Facultad Medica Sanacoop DBA Instituto Sanacoop
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico
City
Guayama
ZIP/Postal Code
00784
Country
Puerto Rico
Facility Name
Hispanic Alliance for Clinical and Translational Research
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
San Juan Hospital
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
San Miguel Medical
City
Trujillo Alto
ZIP/Postal Code
00976
Country
Puerto Rico

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=B7471011
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

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