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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

12,547

Participants

Timeline

Start Date

August 4, 2022

Primary Completion Date

December 26, 2025

Study Completion Date

December 26, 2025

Conditions
Lyme Disease
Interventions
BIOLOGICAL

VLA15

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

OTHER

Saline

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

Trial Locations (120)

12065

Care Access - Albany, Halfmoon

12553

Mid Hudson Medical Research, New Windsor

13045

Smith Allergy and Asthma Specialists, Cortland

13326

Bassett Medical Center, Cooperstown

13850

Velocity Clinical Research, Vestal, Vestal

13905

Velocity Clinical Research, Binghamton, Binghamton

14845

Smith Allergy & Asthma Specialists, Horseheads

15236

Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18), Pittsburgh

15243

Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, Pittsburgh

15401

Preferred Primary Care Physicians, Uniontown

15478

Frontier Clinical Research, LLC, Smithfield

15683

Frontier Clinical Research, LLC, Scottdale

15767

Care Access Mobile Site, Punxsutawney

15801

TruCare Internal Medicine & Infectious Disease, DuBois

16148

CCP - Kid's Way, Hermitage

16506

Allegheny Health and Wellness Pavilion, Erie

16508

Central Erie Primary Care, Erie

16635

Altoona Center For Clinical Research, Duncansville

17099

Care Access Mobile Site, Yeagertown

17901

Care Access - Pottsville, Pottsville

18202

Care Access - Mountaintop, Hazle Township

18508

Care Access - Scranton, Scranton

18510

Northeast Clinical Trials Group, Scranton

18702

Care Access - Wilkes-Barre, Wilkes-Barre

18704

Care Access - Kingston, Kingston

18840

Guthrie Medical Group, P.C., Sayre

Robert Packer Hospital, Sayre

20100

Terveystalo Pulssi, Turku

20520

FVR, Turun rokotetutkimusklinikka, Turku

21093

Johns Hopkins Rockland Physician Practice and Research Group, Lutherville

21157

Sumit Bhutani MD LLC, Westminster

Woodholme Gastroenterology Associates, Westminster

21205

Johns Hopkins, Baltimore

21287

Johns Hopkins Hospital, Baltimore

22601

Amherst Family Practice, P.C., Winchester

28100

FVR, Porin rokotetutkimusklinikka, Pori

33100

FVR, Tampereen rokotetutkimusklinikka, Tampere

53792

University of Wisconsin Carbone Cancer Center-University Hospital, Madison

54449

Marshfield Medical Center - Marshfield, Marshfield

54476

Marshfield Medical Center - Weston, Weston

55116

Internistische Gemeinschaftspraxis Mainz, Mainz

55402

Clinical Research Institute, Minneapolis

67100

FVR, Kokkolan rokotetutkimusklinikka, Kokkola

06426

Care Access - Essex, Essex

06320

Care Access Mobile Site, New London

06902

Stamford Health Medical Group, Stamford

06904

Stamford Hospital, Stamford

04401

Northern Light Eastern Maine Medical Center, Bangor

04938

Care Access - Farmington, Farmington

04856

Pen Bay Medical Center, Rockport

02721

Pediatric Associates of Fall River, Fall River

02347

Care Access - Lakeville, Lakeville

02176

Care Access - Melrose, Melrose

01844

ActivMed Practices and Research, Methuen

02554

Care Access - Briarpatch and Mobile Site, Nantucket

Care Access - Nantucket, Nantucket

Care Access Mobile Site, Nantucket

02061

South Shore Medical Center, Norwell

02370

Care Access - Hingham, Rockland

01103

Sisu BHR, Springfield

02571

Care Access - Wareham, Wareham

02190

South Shore Hospital, Weymouth

01655

University of Massachusetts Chan Medical School, Worcester

03053

Care Access - Londonderry, Londonderry

03860

Care Access - North Conway, North Conway

03801

ActivMed Practices & Research, LLC., Portsmouth

08302

Internal Medicine Associates, Bridgeton

07724

Clinilabs, Eatontown

08822

Hunterdon Infectious Disease Specialists, Flemington

Hunterdon Medical Center, Flemington

07030

Care Access - Hoboken, Hoboken

07059

IMA Clinical Research Warren, Warren Township

02818

Velocity Clinical Research, Providence, East Greenwich

02807

Care Access Mobile Site, New Shoreham

02886

Care Access - Warwick, Warwick

05301

Care Access - Brattleboro - Putney Road, Brattleboro

Care Access - Brattleboro, Brattleboro

05401

The University of Vermont Medical Center Inc., Burlington

05753

Care Access - Middlebury, Middlebury (village)

B4V 3N2

Viable Clinical Research Corporation, Bridgewater

B3K6R8

Canadian Center for Vaccinology, Halifax

L7M 4Y1

Centricity Research Burlington Multispecialty, Burlington

N5W 6A2

Milestone Research Inc., London

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

N7T 4X3

Bluewater Clinical Research Group Inc., Sarnia

L4A 1H2

Stouffville Medical Research Institute Inc., Stouffville

M9W 4L6

Centricity Research Toronto Manna Multispecialty, Toronto

J1L 0H8

Diex Recherche Sherbrooke, Sherbrooke

G6P 3Z8

Diex Recherche Victoriaville, Victoriaville

00100

FVR, Etelä-Helsingin rokotetutkimusklinikka, Helsinki

00930

FVR, Itä-Helsingin rokotetutkimusklinikka, Helsinki

04400

FVR, Järvenpään rokotetutkimusklinikka, Järvenpää

00290

MeVac - Meilahti Vaccine Research Center, Helsinki

04107

AmBeNet GmbH, Leipzig

1105 AZ

Amsterdam UMC, locatie AMC, Amsterdam

62-030

Rodzinne Centrum Medyczne LUBMED, Luboń

87-100

MICS Centrum Medyczne Torun, Torun

30-644

Przylądek Zdrowia, Krakow

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawa II, Krakow

33-100

ALERGO-MED Specjalistyczna Przychodnia Lekarska, Tarnów

55-100

Szpital im. Św. Jadwigi Śląskiej w Trzebnicy, Trzebnica

53-673

Futuremeds spolka z ograniczona odpowiedzialnoscia, Wroclaw

05-092

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym, Łomianki

47-100

Centrum Medyczne Lucyna Andrzej Dymek, Strzelce Opolskie

15-274

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

15-540

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

59-700

Zespol Opieki Zdrowotnej w Boleslawcu, Bolesławiec

81-537

Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

40-018

Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra, Katowice

30-348

Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji, Krakow

31-501

Krakowskie Centrum Medyczne, Krakow

20-044

NZOZ Praktyka Lekarza Rodzinnego Eskulap, Lublin

50-220

Przychodnia EuroMediCare Wroclaw Lowiecka, Wroclaw

51-141

Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny, Wroclaw

371 79

Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona, Karlskrona

171 64

CTC Karolinska, Solna

113 61

Studieenheten Akademiskt Specialistcentrum, Stockholm

752 37

CTC MTC, Uppsala

222 22

ProbarE, Lund

701 85

Universitetssjukhuset Örebro, Örebro

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Valneva Austria GmbH

INDUSTRY

lead

Pfizer

INDUSTRY