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A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.

Primary Purpose

Myocarditis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cardiac Imaging
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myocarditis focused on measuring COMIRNATY, post-vaccine, COVID-19, MIS-C

Eligibility Criteria

0 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cohort 1/2:

    1. Age <21 years.
    2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
    3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset.
    4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
    5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.

  • Cohort 3:

    1. Age <21 years.
    2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.

    3. COVID-19-related disease

      1. Acute COVID-19 infection OR
      2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND

    4. Probable or confirmed myocarditis/pericarditis* not temporally related to vaccination with COMINARTY

      1. Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:

        • Elevated troponin above upper limit of normal
        • Abnormal ECG or rhythm monitoring finding consistent with myocarditis
        • Abnormal cardiac function or wall motion abnormalities on echocardiogram
        • cMRI findings consistent with myocarditis OR

      2. Confirmed myocarditis/pericarditis as defined by:

        • Histopathologic confirmation of myocarditis OR
        • Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis
    5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.

Exclusion Criteria:

  1. A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.

  2. Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of:

    1. Bicommissural aortic valve with < trivial stenosis and/or insufficiency
    2. Mitral valve prolapse with < trivial insufficiency
    3. Hemodynamically insignificant atrial septal or ventricular septal defects.
  3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).

Sites / Locations

  • Children's of AlabamaRecruiting
  • Phoenix Children's HospitalRecruiting
  • Childrens Hospital Los AngelesRecruiting
  • Valley Children's HospitalRecruiting
  • Childrens Hospital of Colorado
  • Connecticut Children's Medical CenterRecruiting
  • Nemours Children's Hospital, DelawareRecruiting
  • Childrens National HospitalRecruiting
  • Children's Healthcare of Atlanta - EglestonRecruiting
  • Lurie Children's HospitalRecruiting
  • Indiana UniversityRecruiting
  • Indiana University School of MedicineRecruiting
  • Children's HospitalRecruiting
  • Boston Children's HospitalRecruiting
  • University of Michigan Hospital-Mott Children's HospitalRecruiting
  • Childrens Mercy Kansas CityRecruiting
  • Northwell Health-Cohen Children's Medical Center
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • The Children's Hospital of Philadelphia
  • Medical University of South Carolina (Musc) - Children's HospitalRecruiting
  • Medical University of South Carolina: Shawn Jenkins Women's and Children's HospitalRecruiting
  • Texas Children's HospitalRecruiting
  • Baylor College Of Medicine (Bcm) - Texas Children's Hospital (Tch)Recruiting
  • Texas Children's HospitalRecruiting
  • Primary Children'sRecruiting
  • Primary Children's HospitalRecruiting
  • Seattle Children's Hospital & Research InstituteRecruiting
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

myocarditis/pericarditis following COMIRNATY

myocarditis/pericarditis following COVID-19 or MIS-C

Arm Description

myocarditis/pericarditis following COMIRNATY within 28 days of dose

myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY

Outcomes

Primary Outcome Measures

Composite findings of myocarditis
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF < 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Myocarditis by original or revised Lake Louise criteria on cMRI
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Complications, including non-cardiac morbidities by medical history
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Behavior Assessment System for Children, Third Edition (BASC-3), <8 yr (T score <30->70 with higher number meaning lower functioning) or PROMIS Short Forms ≥8 yr (scores from 3-15 with higher number meaning better functioning)
The Pediatric Quality of Life Inventory (PEDS QL)
The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to <18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning.
The Quality of Life Scale (QOLS)
The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants ≥18 years old.
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)

Secondary Outcome Measures

Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance.
Time to recovery of myocardial inflammation and injury by Lake Louise (the original or revised) criteria
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Complications, including non-cardiac morbidities for myocarditis
Echocardiographic LVEF
Myocardial inflammation scarring (by cMRI)
Arrhythmias on cardiac recordings
Complications, including non-cardiac morbidities by medical history
Lower LVEF by composite results
Identification of possible sociodemographic and medical risk factors for greater frequency and severity of acute and longer-term cardiac sequelae in participants, measured by ECG, original or revised Lake Louise criteria on cMRI, and presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
For patients with isolated pericarditis, to determine time to recovery to normal.
Freedom from symptoms/signs of pericarditis; typical ECG findings of pericarditis; >small pericardial effusion; therapy with anti-inflammatory medications
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Conduction system disturbances on cardiac recordings

Full Information

First Posted
January 10, 2022
Last Updated
October 4, 2023
Sponsor
Pfizer
Collaborators
Carelon Research, National Health Lung Blood Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05295290
Brief Title
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Official Title
Low Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
November 21, 2029 (Anticipated)
Study Completion Date
November 21, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Carelon Research, National Health Lung Blood Institute

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
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: Are age <21 years. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
Detailed Description
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C. To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis,15 2) have received any dose of COMIRNATY ≤ 7 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment. Inclusion criteria for participants are: Age <21 years Presentation to a participating medical center with evaluation in Emergency Room and/or hospitalization Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY ≤7 days of symptom onset, even if a different brand of COVID-19 vaccine had been administered in earlier vaccinations Retrospectively ascertained participants must be enrolled within 2 years of diagnosis COVID-19 related disease Probable or confirmed myocarditis/pericarditis as per the contemporaneous CDC case definition at the time of diagnosis Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)'s Pediatric Heart Network (PHN) and Pfizer. Approximately 300 prospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care at participating medical centers for myocarditis/pericarditis associated with COMIRNATY, up to 200 retrospectively ascertained cases of persons <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY, and approximately 100 persons <21 years of age with COVID-associated myocarditis/pericarditis, including MIS-C will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis
Keywords
COMIRNATY, post-vaccine, COVID-19, MIS-C

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons less than 21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C, without exposure to COMIRNATY.
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
myocarditis/pericarditis following COMIRNATY
Arm Type
Other
Arm Description
myocarditis/pericarditis following COMIRNATY within 28 days of dose
Arm Title
myocarditis/pericarditis following COVID-19 or MIS-C
Arm Type
Other
Arm Description
myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Imaging
Intervention Description
ECG, echocardiogram, ambulatory monitor, exercise stress test
Primary Outcome Measure Information:
Title
Composite findings of myocarditis
Description
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF < 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Time Frame
6 months after illness onset
Title
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Time Frame
Up to 5 years following illness onset.
Title
Myocarditis by original or revised Lake Louise criteria on cMRI
Time Frame
Up to 5 years following illness onset.
Title
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Time Frame
Up to 5 years following illness onset.
Title
Complications, including non-cardiac morbidities by medical history
Time Frame
Up to 5 years following illness onset.
Title
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Description
Behavior Assessment System for Children, Third Edition (BASC-3), <8 yr (T score <30->70 with higher number meaning lower functioning) or PROMIS Short Forms ≥8 yr (scores from 3-15 with higher number meaning better functioning)
Time Frame
Up to 5 years following illness onset.
Title
The Pediatric Quality of Life Inventory (PEDS QL)
Description
The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to <18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning.
Time Frame
Up to 5 years following illness onset.
Title
The Quality of Life Scale (QOLS)
Description
The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants ≥18 years old.
Time Frame
Up to 5 years following illness onset.
Title
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Time Frame
Up to 5 years following illness onset.
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance.
Time Frame
During the hospitalization or within 2 weeks of hospital discharge, generally obtained less than 3 weeks from presentation.
Title
Time to recovery of myocardial inflammation and injury by Lake Louise (the original or revised) criteria
Time Frame
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Title
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Time Frame
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Title
Complications, including non-cardiac morbidities for myocarditis
Time Frame
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Title
Echocardiographic LVEF
Time Frame
Up to 5 years following illness onset.
Title
Myocardial inflammation scarring (by cMRI)
Time Frame
Up to 5 years following illness onset.
Title
Arrhythmias on cardiac recordings
Time Frame
Up to 5 years following illness onset.
Title
Complications, including non-cardiac morbidities by medical history
Time Frame
Up to 5 years following illness onset.
Title
Lower LVEF by composite results
Description
Identification of possible sociodemographic and medical risk factors for greater frequency and severity of acute and longer-term cardiac sequelae in participants, measured by ECG, original or revised Lake Louise criteria on cMRI, and presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Time Frame
Up to 5 years following illness onset.
Title
For patients with isolated pericarditis, to determine time to recovery to normal.
Description
Freedom from symptoms/signs of pericarditis; typical ECG findings of pericarditis; >small pericardial effusion; therapy with anti-inflammatory medications
Time Frame
At each study visit, up to 5 years, until the endpoint event is met
Title
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Time Frame
During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Title
Conduction system disturbances on cardiac recordings
Time Frame
Up to 5 years following illness onset.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cohort 1/2: Age <21 years. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. Cohort 3: Age <21 years. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. COVID-19-related disease Acute COVID-19 infection OR Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND Probable or confirmed myocarditis/pericarditis* not temporally related to vaccination with COMINARTY Probable myocarditis/pericarditis as defined by ≥ 1 new finding of: Elevated troponin above upper limit of normal Abnormal ECG or rhythm monitoring finding consistent with myocarditis Abnormal cardiac function or wall motion abnormalities on echocardiogram cMRI findings consistent with myocarditis OR Confirmed myocarditis/pericarditis as defined by: Histopathologic confirmation of myocarditis OR Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. Exclusion Criteria: A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis. Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of: Bicommissural aortic valve with < trivial stenosis and/or insufficiency Mitral valve prolapse with < trivial insufficiency Hemodynamically insignificant atrial septal or ventricular septal defects. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
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
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Name
Nemours Children's Hospital, Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Hospital-Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health-Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical University of South Carolina (Musc) - Children's Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College Of Medicine (Bcm) - Texas Children's Hospital (Tch)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2316
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Primary Children's
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital & Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting

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=C4591036
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.

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