ClinicalTrials.gov
History of Changes for Study: NCT05634811
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
Latest version (submitted March 3, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 22, 2022 None (earliest Version on record)
2 December 9, 2022 Study Status and Contacts/Locations
3 December 15, 2022 Study Status and Contacts/Locations
4 December 15, 2022 Recruitment Status, Study Status and Contacts/Locations
5 December 29, 2022 Contacts/Locations and Study Status
6 January 19, 2023 Contacts/Locations and Study Status
7 February 9, 2023 Contacts/Locations and Study Status
8 March 10, 2023 Study Status and Contacts/Locations
9 March 31, 2023 Contacts/Locations and Study Status
10 May 3, 2023 Contacts/Locations and Study Status
11 May 18, 2023 Contacts/Locations and Study Status
12 May 31, 2023 Contacts/Locations and Study Status
13 June 11, 2023 Study Status and Contacts/Locations
14 July 20, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
15 October 23, 2023 Study Status, Contacts/Locations and Study Design
16 December 20, 2023 Study Status, Contacts/Locations and Study Design
17 March 3, 2024 Study Status, Contacts/Locations and Study Design
Comparison Format:
Scroll up to access the controls
Changes (Side-by-Side) for Study: NCT05634811
June 11, 2023 (v13) -- July 20, 2023 (v14)

Changes in: Study Status, Study Design and Contacts/Locations
Open or close this module Study Identification
Unique Protocol ID: C4601012 C4601012
Brief Title: Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
Official Title: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2023 July 2023
Overall Status: RecruitingActive, not recruiting
Study Start: December 12, 2022 December 12, 2022
Primary Completion: June 30, 2025 [Anticipated] June 6, 2025 [Anticipated]
Study Completion: June 30, 2025 [Anticipated] June 6, 2025 [Anticipated]
First Submitted: November 22, 2022 November 22, 2022
First Submitted that
Met QC Criteria:		 November 22, 2022 November 22, 2022
First Posted: December 2, 2022 [Actual] December 2, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 11, 2023 July 20, 2023
Last Update Posted: June 13, 2023 [Actual] July 21, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer Pfizer
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: YesYes
U.S. FDA-regulated Device: NoNo
Data Monitoring: Yes Yes
Open or close this module Study Description
Brief Summary:

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.

We are looking for children who:

  • are healthy
  • are age 5 through 17
  • have not been diagnosed with any form of Lyme disease in the past
  • have not received any vaccines for Lyme disease in the past

Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.

Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.

Everyone participating in this study will:

  • get the shots in a clinic or in a hospital office
  • receive a total of 4 shots
  • receive the first 3 shots within 6 months
  • receive the last shot about 1 year afterwards
  • need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.

We are looking for children who:

  • are healthy
  • are age 5 through 17
  • have not been diagnosed with any form of Lyme disease in the past
  • have not received any vaccines for Lyme disease in the past

Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.

Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.

Everyone participating in this study will:

  • get the shots in a clinic or in a hospital office
  • receive a total of 4 shots
  • receive the first 3 shots within 6 months
  • receive the last shot about 1 year afterwards
  • need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.
Detailed Description:
Open or close this module Conditions
Conditions: Lyme Disease Lyme Disease
Keywords: Borreliosis
Borrelia burgdorferi
Spirochetes
Vector-Borne Disease
Lyme Disease Vaccine
VLA15
Outer Surface Protein A (OspA)
Ticks 		Borreliosis
Borrelia burgdorferi
Spirochetes
Vector-Borne Disease
Lyme Disease Vaccine
VLA15
Outer Surface Protein A (OspA)
Ticks
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: OtherOther
Study Phase: Phase 3Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: RandomizedRandomized
Enrollment: 3000 [Anticipated] 3496 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: VLA15
Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).
 Biological: VLA15
6-valent OspA-based Lyme disease vaccine
Other Names:
  • PF-07307405
Placebo Comparator: Normal Saline (Placebo)
Participants will receive 0.9% sodium chloride solution for injection
Normal Saline
0.9% sodium chloride solution for injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The percentage of participants reporting prompted local reactions
[ Time Frame: Within 7 days following each study intervention administration ]

 The percentage of participants reporting prompted local reactions
[ Time Frame: Within 7 days following each study intervention administration ]
2. The percentage of participants reporting prompted systemic events
[ Time Frame: Within 7 days following each study intervention administration ]

 The percentage of participants reporting prompted systemic events
[ Time Frame: Within 7 days following each study intervention administration ]
3. The percentage of participants reporting adverse events (AEs)
[ Time Frame: Through 1 month following each study intervention administration ]

 The percentage of participants reporting adverse events (AEs)
[ Time Frame: Through 1 month following each study intervention administration ]
4. The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
[ Time Frame: Through study completion, up to 24 months ]

 The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
[ Time Frame: Through study completion, up to 24 months ]
5. The percentage of participants reporting serious adverse events (SAEs)
[ Time Frame: Through study completion, up to 24 months ]

 The percentage of participants reporting serious adverse events (SAEs)
[ Time Frame: Through study completion, up to 24 months ]
Open or close this module Eligibility
Minimum Age: 5 Years 5 Years
Maximum Age: 17 Years 17 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: YesYes
Criteria:

Inclusion Criteria:

  • Healthy participants at enrollment who are determined to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
  • Participants and/or participants' parent(s)/guardian who are willing and able to comply with all scheduled visits, study procedures and lifestyle considerations for the duration of the study.

Exclusion Criteria:

  • Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Any diagnosis of Lyme disease within the past 3 months.
  • Any history of Lyme arthritis, carditis, neuroborreliosis, or other disseminated Lyme Disease (LD), regardless of when diagnosed.
  • Known tick bite within the past 4 weeks.
  • Congenital or acquired immunodeficiency or other conditions or treatments associated with immunosuppression that would inhibit the ability to mount an immune response to a vaccine.
  • Other medical, psychiatric condition, active suicidal ideation/behavior or lab abnormality which increases risk of study participation or, in investigator's judgment is inappropriate for the study.
  • Receipt of a previous vaccination for LD.
  • Treatment for LD in the 3 months prior to study intervention administration.
  • Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
  • Receipt of systemic corticosteroids for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical corticosteroids are permitted.
  • Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
  • Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
  • Participation in other studies involving investigational drugs/vaccines/devices within 28 days prior to study entry and/or during study participation (observational studies are acceptable).
  • Investigator site staff, sponsor/sponsor delegates directly involved in the conduct of the study and their family members; site staff supervised by the investigator and their family members.

Inclusion Criteria:

  • Healthy participants at enrollment who are determined to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
  • Participants and/or participants' parent(s)/guardian who are willing and able to comply with all scheduled visits, study procedures and lifestyle considerations for the duration of the study.

Exclusion Criteria:

  • Female participants that are pregnant, breastfeeding, or have a positive urine pregnancy test at Visit 1. Sexually active females and fertile males unwilling to use contraception as per protocol.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Any diagnosis of Lyme disease within the past 3 months.
  • Any history of Lyme arthritis, carditis, neuroborreliosis, or other disseminated Lyme Disease (LD), regardless of when diagnosed.
  • Known tick bite within the past 4 weeks.
  • Congenital or acquired immunodeficiency or other conditions or treatments associated with immunosuppression that would inhibit the ability to mount an immune response to a vaccine.
  • Other medical, psychiatric condition, active suicidal ideation/behavior or lab abnormality which increases risk of study participation or, in investigator's judgment is inappropriate for the study.
  • Receipt of a previous vaccination for LD.
  • Treatment for LD in the 3 months prior to study intervention administration.
  • Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
  • Receipt of systemic corticosteroids for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical corticosteroids are permitted.
  • Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
  • Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s).
  • Participation in other studies involving investigational drugs/vaccines/devices within 28 days prior to study entry and/or during study participation (observational studies are acceptable).
  • Investigator site staff, sponsor/sponsor delegates directly involved in the conduct of the study and their family members; site staff supervised by the investigator and their family members.
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer 		Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, AlabamaUnited States, Alabama
UAB Child Health Research Unit (CHRU)
[Recruiting]
Birmingham, Alabama, United States, 35233		UAB Child Health Research Unit (CHRU)
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham - School of Medicine
[Recruiting]
Birmingham, Alabama, United States, 35233		University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States, 35233
Lakeview Clinical Research
[Recruiting]
Guntersville, Alabama, United States, 35976		Lakeview Clinical Research
Guntersville, Alabama, United States, 35976
United States, CaliforniaUnited States, California
Coast Clinical Research, LLC
[Recruiting]
Bellflower, California, United States, 90706		Coast Clinical Research, LLC
Bellflower, California, United States, 90706
Apex Research Group LLC
[Recruiting]
Fair Oaks, California, United States, 95628		Apex Research Group LLC
Fair Oaks, California, United States, 95628
United States, ConnecticutUnited States, Connecticut
New England Research Associates
[Recruiting]
Bridgeport, Connecticut, United States, 06606		New England Research Associates
Bridgeport, Connecticut, United States, 06606
Stamford Therapeutics Consortium
[Recruiting]
Stamford, Connecticut, United States, 06905		Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
United States, District of ColumbiaUnited States, District of Columbia
Children's National Medical Center
[Recruiting]
Washington, District of Columbia, United States, 20010		Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, FloridaUnited States, Florida
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
[Recruiting]
Brandon, Florida, United States, 33511		Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Brandon, Florida, United States, 33511
Bio-Medical Research LLC
[Not yet recruiting]
Miami, Florida, United States, 33144		Bio-Medical Research LLC
Miami, Florida, United States, 33144
Bio-Medical Research LLC
[Recruiting]
Miami, Florida, United States, 33144		Bio-Medical Research LLC
Miami, Florida, United States, 33184
Bio-Medical Research LLC
[Not yet recruiting]
Miami, Florida, United States, 33184
GCP Research, Global Clinical professionals
[Recruiting]
Saint Petersburg, Florida, United States, 33705		GCP Research, Global Clinical professionals
Saint Petersburg, Florida, United States, 33705
ForCare Clinical Research
[Recruiting]
Tampa, Florida, United States, 33613		ForCare Clinical Research
Tampa, Florida, United States, 33613
United States, GeorgiaUnited States, Georgia
Tekton Research
[Recruiting]
Atlanta, Georgia, United States, 30341		Tekton Research
Atlanta, Georgia, United States, 30341
United States, IdahoUnited States, Idaho
ASR, LLC
[Recruiting]
Boise, Idaho, United States, 83702		ASR, LLC
Boise, Idaho, United States, 83702
Clinical Research Prime
[Recruiting]
Idaho Falls, Idaho, United States, 83404		Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
United States, IllinoisUnited States, Illinois
University of Chicago Medical Center
[Recruiting]
Chicago, Illinois, United States, 60637		University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, KansasUnited States, Kansas
Alliance for Multispecialty Research, LLC
[Recruiting]
El Dorado, Kansas, United States, 67042		Alliance for Multispecialty Research, LLC
El Dorado, Kansas, United States, 67042
Johnson County Clinical Trials
[Not yet recruiting]
Lenexa, Kansas, United States, 66219		Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
Alliance for Multispecialty Research, LLC
[Recruiting]
Wichita, Kansas, United States, 67207		Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States, 67207
United States, KentuckyUnited States, Kentucky
Kentucky Pediatric/ Adult Research
[Recruiting]
Bardstown, Kentucky, United States, 40004		Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States, 40004
Bluegrass Clinical Research, Inc.
[Recruiting]
Louisville, Kentucky, United States, 40291		Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States, 40291
United States, MarylandUnited States, Maryland
MD Medical Research
[Recruiting]
Oxon Hill, Maryland, United States, 20745		MD Medical Research
Oxon Hill, Maryland, United States, 20745
Virgo Carter Pediatrics
[Recruiting]
Silver Spring, Maryland, United States, 20910		Virgo Carter Pediatrics
Silver Spring, Maryland, United States, 20910
United States, MassachusettsUnited States, Massachusetts
Sisu BHR
[Recruiting]
Springfield, Massachusetts, United States, 01103		Sisu BHR
Springfield, Massachusetts, United States, 01103
United States, MichiganUnited States, Michigan
Michigan Center of Medical Research (MICHMER)
[Recruiting]
Bingham Farms, Michigan, United States, 48025		Michigan Center of Medical Research (MICHMER)
Bingham Farms, Michigan, United States, 48025
Vida Clinical Studies, LLC
[Recruiting]
Dearborn Heights, Michigan, United States, 48124		Vida Clinical Studies, LLC
Dearborn Heights, Michigan, United States, 48124
Vida Clinical Studies, LLC
[Not yet recruiting]
Dearborn Heights, Michigan, United States, 48127		Vida Clinical Studies, LLC
Dearborn Heights, Michigan, United States, 48127
Great Lakes Research Institute
[Recruiting]
Southfield, Michigan, United States, 48075		Great Lakes Research Institute
Southfield, Michigan, United States, 48075
United States, MinnesotaUnited States, Minnesota
Clinical Research Institute
[Recruiting]
Minneapolis, Minnesota, United States, 55402		Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, NebraskaUnited States, Nebraska
Velocity Clinical Research, Omaha
[Recruiting]
Omaha, Nebraska, United States, 68134		Velocity Clinical Research, Omaha
Omaha, Nebraska, United States, 68134
United States, New JerseyUnited States, New Jersey
Hassman Research Institute
[Recruiting]
Berlin, New Jersey, United States, 08009		Hassman Research Institute
Berlin, New Jersey, United States, 08009
Rutgers University
[Recruiting]
New Brunswick, New Jersey, United States, 08901		Rutgers University
New Brunswick, New Jersey, United States, 08901
IMA Clinical Research Warren
[Recruiting]
Warren, New Jersey, United States, 07059		IMA Clinical Research Warren
Warren, New Jersey, United States, 07059
United States, New YorkUnited States, New York
Prime Global Research
[Recruiting]
Bronx, New York, United States, 10456		Prime Global Research
Bronx, New York, United States, 10456
Advantage Clinical Trials
[Recruiting]
Bronx, New York, United States, 10468		Advantage Clinical Trials
Bronx, New York, United States, 10468
Buffalo Clinical and Translational Research Center
[Recruiting]
Buffalo, New York, United States, 14203		Buffalo Clinical and Translational Research Center
Buffalo, New York, United States, 14203
Advanced Specialty Care
[Recruiting]
Commack, New York, United States, 11725		Advanced Specialty Care
Commack, New York, United States, 11725
Smith Allergy and Asthma Specialists
[Recruiting]
Cortland, New York, United States, 13045		Smith Allergy and Asthma Specialists
Cortland, New York, United States, 13045
Stony Brook Medicine Clinical Research Center
[Recruiting]
East Setauket, New York, United States, 11733		Stony Brook Medicine Clinical Research Center
East Setauket, New York, United States, 11733
Meridian Clinical Research, LLC
[Recruiting]
Endwell, New York, United States, 13760		Meridian Clinical Research, LLC
Endwell, New York, United States, 13760
Southampton Hospital
[Recruiting]
Hampton Bays, New York, United States, 11946		Southampton Hospital
Hampton Bays, New York, United States, 11946
Smith Allergy & Asthma Specialists
[Recruiting]
Horseheads, New York, United States, 14845		Smith Allergy & Asthma Specialists
Horseheads, New York, United States, 14845
NYU Langone Hospital - Long Island
[Recruiting]
Mineola, New York, United States, 11501		NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
DiGiovanna Institute for Medical Education & Research
[Recruiting]
North Massapequa, New York, United States, 11758		DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, United States, 11758
Rochester Clinical Research, Inc.
[Recruiting]
Rochester, New York, United States, 14609		Rochester Clinical Research, LLC
Rochester, New York, United States, 14609
Stony Brook University
[Recruiting]
Stony Brook, New York, United States, 11794		Stony Brook University
Stony Brook, New York, United States, 11794
SUNY Upstate Medical University
[Recruiting]
Syracuse, New York, United States, 13215		SUNY Upstate Medical University
Syracuse, New York, United States, 13215
Meridian Clinical Research, LLC
[Recruiting]
Vestal, New York, United States, 13850		Meridian Clinical Research, LLC
Vestal, New York, United States, 13850
United States, OhioUnited States, Ohio
Aventiv Research Inc
[Recruiting]
Columbus, Ohio, United States, 43213		Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States, 43213
United States, PennsylvaniaUnited States, Pennsylvania
Allegheny Health and Wellness Pavilion
[Recruiting]
Erie, Pennsylvania, United States, 16506		Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States, 16506
Central Erie Primary Care
[Recruiting]
Erie, Pennsylvania, United States, 16508		Central Erie Primary Care
Erie, Pennsylvania, United States, 16508
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15236		Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, United States, 15236
Northeast Clinical Trials Group
[Recruiting]
Scranton, Pennsylvania, United States, 18510		Northeast Clinical Trials Group
Scranton, Pennsylvania, United States, 18510
United States, South CarolinaUnited States, South Carolina
Coastal Carolina Research Center
[Recruiting]
North Charleston, South Carolina, United States, 29405		Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
United States, TexasUnited States, Texas
Benchmark Research
[Recruiting]
Austin, Texas, United States, 78705		Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research
[Recruiting]
Fort Worth, Texas, United States, 76135		Benchmark Research
Fort Worth, Texas, United States, 76135
Texas Health Resources
[Recruiting]
Fort Worth, Texas, United States, 76135		Texas Health Resources
Fort Worth, Texas, United States, 76135
C & R Research Services USA
[Recruiting]
Houston, Texas, United States, 77022		C & R Research Services USA
Houston, Texas, United States, 77022
DM Clinical Research - Cy Fair
[Recruiting]
Houston, Texas, United States, 77065		DM Clinical Research - Cy Fair
Houston, Texas, United States, 77065
DM Clinical Research
[Recruiting]
Houston, Texas, United States, 77065		DM Clinical Research
Houston, Texas, United States, 77065
Research Your Health
[Recruiting]
Plano, Texas, United States, 75093		Research Your Health
Plano, Texas, United States, 75093
Sun Research Institute
[Recruiting]
San Antonio, Texas, United States, 78215		Sun Research Institute
San Antonio, Texas, United States, 78215
United States, UtahUnited States, Utah
Velocity Clinical Research, Salt Lake City
[Recruiting]
West Jordan, Utah, United States, 84088		Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
United States, VirginiaUnited States, Virginia
Pediatric Research of Charlottesville, LLC
[Recruiting]
Charlottesville, Virginia, United States, 22902		Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States, 22902
Clinical Research Partners, LLC
[Recruiting]
Richmond, Virginia, United States, 23226		Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
United States, West VirginiaUnited States, West Virginia
Frontier Clinical Research, LLC
[Recruiting]
Kingwood, West Virginia, United States, 26537		Frontier Clinical research
Kingwood, West Virginia, United States, 26537
Frontier Clinical research
[Recruiting]
Kingwood, West Virginia, United States, 26537		Preston Healthcare Services
Kingwood, West Virginia, United States, 26537
Preston Healthcare Services
[Recruiting]
Kingwood, West Virginia, United States, 26537
Open or close this module IPDSharing
Plan to Share IPD: Yes
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. 		Yes
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.
Supporting Information:
Supporting Information:
Time Frame:
Time Frame:
Access Criteria:
Access Criteria:
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requestsURL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Open or close this module References
Citations:
Links:
Description: To obtain contact information for a study center near you, click here.
Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services