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Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

Primary Purpose

Lyme Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VLA15
Normal Saline
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lyme Disease focused on measuring Borreliosis, Borrelia burgdorferi, Spirochetes, Vector-Borne Disease, Lyme Disease Vaccine, VLA15, Outer Surface Protein A (OspA), Ticks

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UAB Child Health Research Unit (CHRU)
  • University of Alabama at Birmingham - School of Medicine
  • Lakeview Clinical Research
  • Coast Clinical Research, LLC
  • Apex Research Group LLC
  • New England Research Associates
  • Stamford Therapeutics Consortium
  • Children's National Medical Center
  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
  • Bio-Medical Research LLC
  • Bio-Medical Research LLC
  • GCP Research, Global Clinical professionals
  • ForCare Clinical Research
  • Tekton Research
  • ASR, LLC
  • Clinical Research Prime
  • University of Chicago Medical Center
  • Alliance for Multispecialty Research, LLC
  • Johnson County Clinical Trials
  • Alliance for Multispecialty Research, LLC
  • Kentucky Pediatric/ Adult Research
  • Bluegrass Clinical Research, Inc.
  • MD Medical Research
  • Virgo Carter Pediatrics
  • Sisu BHR
  • Michigan Center of Medical Research (MICHMER)
  • Vida Clinical Studies, LLC
  • Vida Clinical Studies, LLC
  • Great Lakes Research Institute
  • Clinical Research Institute
  • Velocity Clinical Research, Omaha
  • Hassman Research Institute
  • Rutgers University
  • IMA Clinical Research Warren
  • Prime Global Research
  • Advantage Clinical Trials
  • Advantage Clinical Trials
  • Buffalo Clinical and Translational Research Center
  • Advanced Specialty Care
  • Smith Allergy and Asthma Specialists
  • Stony Brook Medicine Clinical Research Center
  • Meridian Clinical Research, LLC
  • Southampton Hospital
  • Smith Allergy & Asthma Specialists
  • NYU Langone Hospital - Long Island
  • DiGiovanna Institute for Medical Education & Research
  • Rochester Clinical Research, LLC
  • Stony Brook University
  • SUNY Upstate Medical University
  • Meridian Clinical Research, LLC
  • Centricity Research Columbus Ohio Multispecialty
  • Allegheny Health and Wellness Pavilion
  • Central Erie Primary Care
  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
  • Northeast Clinical Trials Group
  • Coastal Carolina Research Center
  • Benchmark Research
  • Benchmark Research
  • Texas Health Resources
  • C & R Research Services USA
  • DM Clinical Research - Cy Fair
  • DM Clinical Research
  • Research Your Health
  • Sun Research Institute
  • Velocity Clinical Research, Salt Lake City
  • Pediatric Research of Charlottesville, LLC
  • Clinical Research Partners, LLC
  • Frontier Clinical research
  • Preston Healthcare Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VLA15

Normal Saline (Placebo)

Arm Description

Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).

Participants will receive 0.9% sodium chloride solution for injection

Outcomes

Primary Outcome Measures

The percentage of participants reporting prompted local reactions
The percentage of participants reporting prompted systemic events
The percentage of participants reporting adverse events (AEs)
The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
The percentage of participants reporting serious adverse events (SAEs)

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
October 23, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05634811
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
June 6, 2025 (Anticipated)
Study Completion Date
June 6, 2025 (Anticipated)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
Borreliosis, Borrelia burgdorferi, Spirochetes, Vector-Borne Disease, Lyme Disease Vaccine, VLA15, Outer Surface Protein A (OspA), Ticks

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VLA15
Arm Type
Experimental
Arm Description
Participants will receive 6-valent OspA-based Lyme disease vaccine (VLA15).
Arm Title
Normal Saline (Placebo)
Arm Type
Placebo Comparator
Arm Description
Participants will receive 0.9% sodium chloride solution for injection
Intervention Type
Biological
Intervention Name(s)
VLA15
Other Intervention Name(s)
PF-07307405
Intervention Description
6-valent OspA-based Lyme disease vaccine
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
0.9% sodium chloride solution for injection
Primary Outcome Measure Information:
Title
The percentage of participants reporting prompted local reactions
Time Frame
Within 7 days following each study intervention administration
Title
The percentage of participants reporting prompted systemic events
Time Frame
Within 7 days following each study intervention administration
Title
The percentage of participants reporting adverse events (AEs)
Time Frame
Through 1 month following each study intervention administration
Title
The percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Time Frame
Through study completion, up to 24 months
Title
The percentage of participants reporting serious adverse events (SAEs)
Time Frame
Through study completion, up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
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
UAB Child Health Research Unit (CHRU)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham - School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Lakeview Clinical Research
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Coast Clinical Research, LLC
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Apex Research Group LLC
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
New England Research Associates
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Bio-Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Bio-Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
GCP Research, Global Clinical professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Tekton Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
ASR, LLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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
Johnson County Clinical Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Kentucky Pediatric/ Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Bluegrass Clinical Research, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
MD Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Virgo Carter Pediatrics
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Sisu BHR
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Michigan Center of Medical Research (MICHMER)
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Vida Clinical Studies, LLC
City
Dearborn Heights
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Vida Clinical Studies, LLC
City
Dearborn Heights
State/Province
Michigan
ZIP/Postal Code
48127
Country
United States
Facility Name
Great Lakes Research Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Velocity Clinical Research, Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
IMA Clinical Research Warren
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Facility Name
Prime Global Research
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Advantage Clinical Trials
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Advantage Clinical Trials
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Buffalo Clinical and Translational Research Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Advanced Specialty Care
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Smith Allergy and Asthma Specialists
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Stony Brook Medicine Clinical Research Center
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Southampton Hospital
City
Hampton Bays
State/Province
New York
ZIP/Postal Code
11946
Country
United States
Facility Name
Smith Allergy & Asthma Specialists
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
DiGiovanna Institute for Medical Education & Research
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Rochester Clinical Research, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Centricity Research Columbus Ohio Multispecialty
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Central Erie Primary Care
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Northeast Clinical Trials Group
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Texas Health Resources
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
C & R Research Services USA
City
Houston
State/Province
Texas
ZIP/Postal Code
77022
Country
United States
Facility Name
DM Clinical Research - Cy Fair
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
DM Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Velocity Clinical Research, Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Frontier Clinical research
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States
Facility Name
Preston Healthcare Services
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States

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=C4601012
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

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