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An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)

Primary Purpose

Lyme Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VLA15
Saline
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lyme Disease focused on measuring VLA15, Lyme Borreliosis, Vaccine, Tick

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to:
  • Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.
  • Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas.
  • Individuals who live on land plots with tree lines and come into contact with these trees regularly.
  • Individuals who have dogs that regularly are outdoors and frequently return with attached ticks.
  • Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides.

Key Exclusion Criteria:

  • Any diagnosis of Lyme disease within the past 3 months.
  • Any history of Lyme carditis, neuroborreliosis, or arthritis, regardless of when diagnosed.
  • Known tick bite within the past 4 weeks.
  • Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
  • Any autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease.
  • Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.

Sites / Locations

  • Care Access - Essex
  • Care Access Mobile Site
  • Stamford Health Medical GroupRecruiting
  • Stamford HospitalRecruiting
  • Northern Light Eastern Maine Medical CenterRecruiting
  • Care Access - Farmington
  • Care Access - Farmington
  • Pen Bay Medical CenterRecruiting
  • Care Access - South Portland
  • Johns Hopkins
  • Johns Hopkins Bayview Medical Center
  • Johns Hopkins Hospital
  • Johns Hopkins Rockland Physician Practice and Research Group
  • Sumit Bhutani MD LLCRecruiting
  • Woodholme Gastroenterology AssociatesRecruiting
  • Pediatric Associates of Fall RiverRecruiting
  • Care Access - Lakeville
  • Care Access - Melrose
  • ActivMed Practices and ResearchRecruiting
  • Care Access - Briarpatch and Mobile Site
  • Care Access - Nantucket
  • Care Access Mobile Site
  • South Shore Medical Center
  • Care Access - Hingham
  • Sisu BHRRecruiting
  • Care Access - Wareham
  • South Shore Hospital
  • University of Massachusetts Chan Medical SchoolRecruiting
  • Clinical Research InstituteRecruiting
  • Care Access - Londonderry
  • Care Access - North Conway
  • ActivMed Practices & Research, LLC.Recruiting
  • Internal Medicine AssociatesRecruiting
  • ClinilabsRecruiting
  • Hunterdon Infectious Disease Specialists
  • Care Access - Hoboken
  • IMA Clinical Research WarrenRecruiting
  • Bassett Medical Center
  • Smith Allergy and Asthma SpecialistsRecruiting
  • Care Access - Albany
  • Care Access - Albany
  • Smith Allergy & Asthma SpecialistsRecruiting
  • United Health Services at Wilson Memorial HospitalRecruiting
  • Mid Hudson Medical ResearchRecruiting
  • Velocity Clinical Research, VestalRecruiting
  • TruCare Internal Medicine & Infectious Disease
  • Altoona Center For Clinical ResearchRecruiting
  • Allegheny Health and Wellness PavilionRecruiting
  • Central Erie Primary CareRecruiting
  • Care Access - Mountaintop
  • CCP - Kid's WayRecruiting
  • Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals
  • Care Access - Kingston
  • Care Access - Malvern
  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Recruiting
  • Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairRecruiting
  • Care Access - Pottsville
  • Care Access Mobile Site
  • Guthrie Medical Group, P. C.Recruiting
  • Robert Packer HospitalRecruiting
  • Frontier Clinical Research, LLCRecruiting
  • Care Access - Scranton
  • Northeast Clinical Trials GroupRecruiting
  • Frontier Clinical Research, LLCRecruiting
  • Preferred Primary Care PhysiciansRecruiting
  • Care Access - Wilkes-Barre
  • Care Access Mobile Site
  • Velocity Clinical Research, ProvidenceRecruiting
  • Care Access Mobile Site
  • Care New England Medical Group
  • Care Access - Warwick
  • Kent Hospital
  • Care Access - Brattleboro - Putney Road
  • Care Access - Brattleboro
  • The University of Vermont Medical Center Inc.Recruiting
  • Care Access - Middlebury
  • Amherst Family Practice, P.C.Recruiting
  • University Hospital and UW Health ClinicsRecruiting
  • Marshfield Medical Center - MarshfieldRecruiting
  • Marshfield Medical Center - Weston
  • Viable Clinical Research CorporationRecruiting
  • Canadian Center for VaccinologyRecruiting
  • Centricity Research Burlington MultispecialtyRecruiting
  • Milestone Research Inc.Recruiting
  • Bluewater Clinical Research Group Inc.Recruiting
  • Stouffville Medical Research Institute Inc.Recruiting
  • Centricity Research Toronto Manna MultispecialtyRecruiting
  • Diex Recherche Sherbrooke Inc.Recruiting
  • Diex Recherche Victoriavile Inc.Recruiting
  • FVR, Tampereen rokotetutkimusklinikka
  • FVR, Etelä-Helsingin rokotetutkimusklinikka
  • FVR, Itä-Helsingin rokotetutkimusklinikka
  • FVR, Järvenpään rokotetutkimusklinikka
  • FVR, Turun rokotetutkimusklinikkaRecruiting
  • MeVac - Meilahti Vaccine Research Center
  • FVR, Kokkolan rokotetutkimusklinikka
  • FVR, Porin rokotetutkimusklinikka
  • FVR, Porin rokotetutkimusklinikka
  • Tampere Vaccine Research Clinic
  • Terveystalo Pulssi
  • AmBeNet GmbHRecruiting
  • Internistische Gemeinschaftspraxis Mainz
  • Amsterdam UMC, locatie AMCRecruiting
  • Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
  • Futuremeds spolka z ograniczona odpowiedzialnoscia
  • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla RodzinyRecruiting
  • MICS Centrum Medyczne Torun
  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
  • Przylądek Zdrowia
  • Krakowski Szpital Specjalistyczny im. Jana Pawa II
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska
  • Centrum Medyczne Lucyna Andrzej Dymek
  • Rodzinne Centrum Medyczne LUBMED
  • Ośrodek Wsparcia Badań Klinicznych
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Zespol Opieki Zdrowotnej w Boleslawcu
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
  • Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji
  • Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji
  • Krakowskie Centrum Medyczne
  • NZOZ Praktyka Lekarza Rodzinnego Eskulap
  • Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w PoznaniuRecruiting
  • Przychodnia EuroMediCare Wroclaw Lowiecka
  • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
  • Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - KarlskronaRecruiting
  • CTC Karolinska
  • Studieenheten Akademiskt Specialistcentrum
  • CTC MTC
  • ProbarE
  • Universitetssjukhuset Örebro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

VLA15 Lot 1 (3-dose primary vaccination series and booster dose)

VLA15 Lot 2 (3-dose primary vaccination series and booster dose)

VLA15 Lot 3 (3-dose primary vaccination series and booster dose)

Placebo (3-dose primary vaccination series and booster dose)

Arm Description

Shot in the deltoid muscle (preferable in the nondominant arm)

Shot in the deltoid muscle (preferable in the nondominant arm)

Shot in the deltoid muscle (preferable in the nondominant arm)

Shot in the deltoid muscle (preferable in the nondominant arm)

Outcomes

Primary Outcome Measures

Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
Percentage of participants reporting local reactions
Percentage of participants reporting systemic events
Percentage of participants reporting adverse events (AEs)
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Percentage of participants reporting serious adverse events (SAEs)
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)
Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata.

Secondary Outcome Measures

Vaccine efficacy among participants enrolled from North American sites
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
Vaccine efficacy among participants after primary series
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee

Full Information

First Posted
July 5, 2022
Last Updated
October 12, 2023
Sponsor
Pfizer
Collaborators
Valneva Austria GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05477524
Brief Title
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
Acronym
VALOR
Official Title
A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Valneva Austria GmbH

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 main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,000 healthy participants 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence. Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months later. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective. If enrolled, participants will need to visit the research site at least 7 times during the study. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
VLA15, Lyme Borreliosis, Vaccine, Tick

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VLA15 Lot 1 (3-dose primary vaccination series and booster dose)
Arm Type
Experimental
Arm Description
Shot in the deltoid muscle (preferable in the nondominant arm)
Arm Title
VLA15 Lot 2 (3-dose primary vaccination series and booster dose)
Arm Type
Experimental
Arm Description
Shot in the deltoid muscle (preferable in the nondominant arm)
Arm Title
VLA15 Lot 3 (3-dose primary vaccination series and booster dose)
Arm Type
Experimental
Arm Description
Shot in the deltoid muscle (preferable in the nondominant arm)
Arm Title
Placebo (3-dose primary vaccination series and booster dose)
Arm Type
Placebo Comparator
Arm Description
Shot in the deltoid muscle (preferable in the nondominant arm)
Intervention Type
Biological
Intervention Name(s)
VLA15
Intervention Description
Shot in the deltoid muscle (preferable in the nondominant arm)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Shot in the deltoid muscle (preferable in the nondominant arm)
Primary Outcome Measure Information:
Title
Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group
Description
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
Time Frame
Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)).
Title
Percentage of participants reporting local reactions
Time Frame
Within 7 days following each study intervention administration
Title
Percentage of participants reporting systemic events
Time Frame
Within 7 days following each study intervention administration
Title
Percentage of participants reporting adverse events (AEs)
Time Frame
Through 1 month following each study intervention administration
Title
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Time Frame
Through study completion, up to approximately 30 months.
Title
Percentage of participants reporting serious adverse events (SAEs)
Time Frame
Through study completion, up to approximately 30 months.
Title
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2
Time Frame
At 1 month after completion of the primary series and the booster dose
Title
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3
Time Frame
At 1 month after completion of the primary series and the booster dose
Title
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3
Time Frame
At 1 month after completion of the primary series and the booster dose
Title
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)
Description
Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata.
Time Frame
At 1 month after completion of the booster dose
Secondary Outcome Measure Information:
Title
Vaccine efficacy among participants enrolled from North American sites
Description
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
Time Frame
Through the end of the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until end of October)
Title
Vaccine efficacy among participants after primary series
Description
A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
Time Frame
Through the end of the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until end of October)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to: Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management. Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas. Individuals who live on land plots with tree lines and come into contact with these trees regularly. Individuals who have dogs that regularly are outdoors and frequently return with attached ticks. Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides. Key Exclusion Criteria: Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding. Any diagnosis of Lyme disease within the past 3 months. Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated Lyme disease regardless of when diagnosed. Known tick bite within the past 4 weeks. Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease. Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease. Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.
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
Care Access - Essex
City
Essex
State/Province
Connecticut
ZIP/Postal Code
06426
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access Mobile Site
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Stamford Health Medical Group
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Individual Site Status
Recruiting
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern Light Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Farmington
City
Farmington
State/Province
Maine
ZIP/Postal Code
04938
Country
United States
Individual Site Status
Withdrawn
Facility Name
Care Access - Farmington
City
Farmington
State/Province
Maine
ZIP/Postal Code
04938
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Pen Bay Medical Center
City
Rockport
State/Province
Maine
ZIP/Postal Code
04856
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - South Portland
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Johns Hopkins Rockland Physician Practice and Research Group
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sumit Bhutani MD LLC
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Individual Site Status
Recruiting
Facility Name
Woodholme Gastroenterology Associates
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Associates of Fall River
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Lakeville
City
Lakeville
State/Province
Massachusetts
ZIP/Postal Code
02347
Country
United States
Individual Site Status
Withdrawn
Facility Name
Care Access - Melrose
City
Melrose
State/Province
Massachusetts
ZIP/Postal Code
02176
Country
United States
Individual Site Status
Withdrawn
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Briarpatch and Mobile Site
City
Nantucket
State/Province
Massachusetts
ZIP/Postal Code
02554
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access - Nantucket
City
Nantucket
State/Province
Massachusetts
ZIP/Postal Code
02554
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access Mobile Site
City
Nantucket
State/Province
Massachusetts
ZIP/Postal Code
02554
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
South Shore Medical Center
City
Norwell
State/Province
Massachusetts
ZIP/Postal Code
02061
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access - Hingham
City
Rockland
State/Province
Massachusetts
ZIP/Postal Code
02370
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sisu BHR
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Wareham
City
Wareham
State/Province
Massachusetts
ZIP/Postal Code
02571
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
South Shore Hospital
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Massachusetts Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Londonderry
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access - North Conway
City
N. Conway
State/Province
New Hampshire
ZIP/Postal Code
03860
Country
United States
Individual Site Status
Withdrawn
Facility Name
ActivMed Practices & Research, LLC.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Name
Internal Medicine Associates
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinilabs
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Individual Site Status
Recruiting
Facility Name
Hunterdon Infectious Disease Specialists
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access - Hoboken
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
IMA Clinical Research Warren
City
Warren
State/Province
New Jersey
ZIP/Postal Code
07059
Country
United States
Individual Site Status
Recruiting
Facility Name
Bassett Medical Center
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Smith Allergy and Asthma Specialists
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Albany
City
Halfmoon
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access - Albany
City
Halfmoon
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Smith Allergy & Asthma Specialists
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Individual Site Status
Recruiting
Facility Name
United Health Services at Wilson Memorial Hospital
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Vestal
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Individual Site Status
Recruiting
Facility Name
TruCare Internal Medicine & Infectious Disease
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Erie Primary Care
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Mountaintop
City
Hazle Township
State/Province
Pennsylvania
ZIP/Postal Code
18202
Country
United States
Individual Site Status
Withdrawn
Facility Name
CCP - Kid's Way
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Individual Site Status
Recruiting
Facility Name
Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
16641
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Care Access - Kingston
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Individual Site Status
Withdrawn
Facility Name
Care Access - Malvern
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Individual Site Status
Withdrawn
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Pottsville
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access Mobile Site
City
Punxsutawney
State/Province
Pennsylvania
ZIP/Postal Code
15767
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Guthrie Medical Group, P. C.
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Individual Site Status
Recruiting
Facility Name
Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research, LLC
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Scranton
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18508
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northeast Clinical Trials Group
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Wilkes-Barre
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access Mobile Site
City
Yeagertown
State/Province
Pennsylvania
ZIP/Postal Code
17099
Country
United States
Individual Site Status
Withdrawn
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access Mobile Site
City
New Shoreham
State/Province
Rhode Island
ZIP/Postal Code
02807
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care New England Medical Group
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Care Access - Warwick
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Care Access - Brattleboro - Putney Road
City
Brattleboro
State/Province
Vermont
ZIP/Postal Code
05301
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Care Access - Brattleboro
City
Brattleboro
State/Province
Vermont
ZIP/Postal Code
05301
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Vermont Medical Center Inc.
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access - Middlebury
City
Middlebury
State/Province
Vermont
ZIP/Postal Code
05753
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Amherst Family Practice, P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospital and UW Health Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Marshfield Medical Center - Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Viable Clinical Research Corporation
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Canadian Center for Vaccinology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K6R8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research Burlington Multispecialty
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Milestone Research Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Stouffville Medical Research Institute Inc.
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research Toronto Manna Multispecialty
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Victoriavile Inc.
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Individual Site Status
Recruiting
Facility Name
FVR, Tampereen rokotetutkimusklinikka
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33100
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
FVR, Etelä-Helsingin rokotetutkimusklinikka
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
FVR, Itä-Helsingin rokotetutkimusklinikka
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00930
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
FVR, Järvenpään rokotetutkimusklinikka
City
Järvenpää
State/Province
Uusimaa
ZIP/Postal Code
04400
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
FVR, Turun rokotetutkimusklinikka
City
Turku
State/Province
Varsinais-suomi
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Name
MeVac - Meilahti Vaccine Research Center
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
FVR, Kokkolan rokotetutkimusklinikka
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
FVR, Porin rokotetutkimusklinikka
City
Pori
ZIP/Postal Code
28100
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
FVR, Porin rokotetutkimusklinikka
City
Pori
ZIP/Postal Code
28100
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Tampere Vaccine Research Clinic
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Terveystalo Pulssi
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
AmBeNet GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04107
Country
Germany
Individual Site Status
Recruiting
Facility Name
Internistische Gemeinschaftspraxis Mainz
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Amsterdam UMC, locatie AMC
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
City
Trzebnica
State/Province
Dolnośląskie
ZIP/Postal Code
55-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Futuremeds spolka z ograniczona odpowiedzialnoscia
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-088
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
51-141
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Torun
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
City
Lomianki
State/Province
Mazowieckie
ZIP/Postal Code
05-092
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Przylądek Zdrowia
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
30-644
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawa II
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska
City
Tarnow
State/Province
Małopolskie
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne Lucyna Andrzej Dymek
City
Strzelce Opolskie
State/Province
Opolskie
ZIP/Postal Code
47-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Rodzinne Centrum Medyczne LUBMED
City
Lubon
State/Province
Wielkopolskie
ZIP/Postal Code
62-030
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Ośrodek Wsparcia Badań Klinicznych
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Zespol Opieki Zdrowotnej w Boleslawcu
City
Boleslawiec
ZIP/Postal Code
59-700
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
City
Katowice
ZIP/Postal Code
40-018
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji
City
Krakow
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Krakowskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
NZOZ Praktyka Lekarza Rodzinnego Eskulap
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
City
Poznan
ZIP/Postal Code
60-663
Country
Poland
Individual Site Status
Recruiting
Facility Name
Przychodnia EuroMediCare Wroclaw Lowiecka
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
City
Wroclaw
ZIP/Postal Code
51-141
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona
City
Karlskrona
State/Province
Blekinge LÄN [se-10]
ZIP/Postal Code
371 79
Country
Sweden
Individual Site Status
Recruiting
Facility Name
CTC Karolinska
City
Solna
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Studieenheten Akademiskt Specialistcentrum
City
Stockholm
State/Province
Stockholms LÄN [se-01]
ZIP/Postal Code
113 61
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
CTC MTC
City
Uppsala
State/Province
Uppsala LÄN [se-03]
ZIP/Postal Code
752 37
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
ProbarE
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Universitetssjukhuset Örebro
City
Örebro
State/Province
Örebro LÄN [se-18]
ZIP/Postal Code
701 85
Country
Sweden
Individual Site Status
Active, not 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=C4601003
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

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