A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

PHASE3CompletedINTERVENTIONAL
Enrollment

3,596

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Meningococcal Vaccine
Interventions
BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months (lot 1)

BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months (lot 2)

BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months (lot 3)

BIOLOGICAL

Havrix (HAV)

0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.

BIOLOGICAL

Saline

0.5 mL dose of sterile normal saline for injection.

Trial Locations (99)

11501

Winthrop Division of Pediatric Infectious Diseases, Mineola

Winthrop Pediatric Associates, Mineola

Winthrop University Pharmacy, Mineola

Winthrop-University Hospital - Clinical Trials Center, Mineola

14609

Rochester Clinical Research, Inc., Rochester

15241

PEAK Research, LLC, Upper Saint Clair

15401

Preferred Primary Care Physicians, Inc., Uniontown

16000

Ordinace praktickeho lekare pro deti a dorost, Prague

16132

Dipartimento di Scienze della Salute, Genova

16508

Liberty Family Practice, Erie

20122

UOC di Pediatria 1, Milan

22180

Advanced Pediatrics, Vienna

22902

Pediatric Research of Charlottesville, LLC, Charlottesville

Pediatric Research of Charlottesville, Charlottesville

25001

Ordinace praktickeho lekare pro deti a dorost, Brandýs nad Labem-Stará Boleslav

25070

Ordinace praktickeho lekare pro deti a dorost, Odolena Voda

27203

Asheboro Research Associates, Asheboro

27518

Cary Pediatric Center, Cary

27609

Capitol Pediatrics & Adolescent Center PLLC, Raleigh

30721

North Georgia Clinical Research Center, Dalton

32216

Jacksonville Center for Clinical Research, Jacksonville

32934

Accelovance, Melbourne

32935

Accelovance, Melbourne

33012

Aga Clinical Trials, Hialeah

35205

Birmingham Pediatric Associates, PC, Birmingham

35235

Alabama Clinical Therapeutics, LLC, Birmingham

36305

Southeastern Pediatrics, Dothan

37087

Cumberland Pediatrics Associates, Lebanon

37660

Holston Medical Group - Suite 3B, Kingsport

Holston Medical Group Laboratory, Kingsport

Holston Medical Group, Kingsport

37701

Ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

40004

Kentucky Pediatric/Adult Research, Bardstown

40291

Bluegrass Clinical Research, Inc., Louisville

40353

Central Kentucky Research Associates, Inc., Mount Sterling

Mt. Sterling Pediatrics, Mount Sterling

42301

Pedia Research, LLC, Owensboro

44121

Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics, Cleveland

45406

Dayton Clinical Research, Dayton

45414

Ohio Pediatric Research Association, Dayton

Ohio Pediatrics, Inc., Dayton

46256

Northpoint Pediatrics, Indianapolis

46545

Accelovance, Inc., Mishawaka

Optimal Research, LLC, Mishawaka

47150

Nassim, McMonigle, Mescia & Associates, New Albany

49120

Southwestern Medical Clinic Lakeland HealthCare Affiliate, Niles

49565

Kinderarztpraxis Dr. Thomas Adelt, Bramsche

50002

Ordinace praktickeho lekare pro deti a dorost, Hradec Králové

53002

MUDr. Elena Adamkova, Pardubice

53012

Zdravotnicke stredisko Dubina v.o.s., Pardubice

55108

Allina Health Bandana Square Clinic, Saint Paul

60115

Northern Illinois Research Associates, DeKalb

63141

Sundance Clinical Research, LLC, St Louis

67010

Augusta Family Practice, Augusta

Heartland Research Associates, LLC, Augusta

67114

Heartland Research Associates, LLC, Newton

67205

Heartland Research Associates, LLC, Wichita

67207

Heartland Research Associates, LLC, Wichita

68005

Bellevue Urgent Care, Bellevue

Pioneer Clinical Research, LLC, Bellevue

68131

Creighton University Medical Center, Omaha

68134

Meridian Clinical Research, Llc, Omaha

70006

Benchmark Research, Metairie

70535

David B. Ware, MD, Eunice

Horizon Research Group of Opelousas, LLC, Eunice

71037

ACC Pediatric Research, Haughton

72205

Arkansas Pediatric Clinic, Little Rock

72401

The Children's Clinic of Jonesboro, P.A., Jonesboro

72432

Harrisburg Family Medical Center, Harrisburg

77694

Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel, Kehl

80922

Colorado Springs Health Partners/Clinical Research Advantage, Inc., Colorado Springs

90220

Oulu Vaccine Research Clinic, Oulu

97070

Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg

97100

Azienda Sanitaria Provinciale di Ragusa, Ragusa

98664

The Vancouver Clinic, Vancouver

92103-6204

California Research Foundation, San Diego

P3E 1H5

Medicor Research Inc., Greater Sudbury

M5G 1N8

Dr. Hartley Garfield Medicine Professional Corporation, Toronto

G1W 4R4

Clinique Medicale St-Louis (recherche) Inc., Québec

G3K 2P8

ALPHA Recherche Clinique, Québec

J1H 1Z1

Diex Research Sherbrooke Inc., Sherbrooke

500 05

Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny, Hradec Králové

00930

Helsinki East Vaccine Research Clinic, Helsinki

04400

Jarvenpaa Vaccine Research Clinic, Järvenpää

01300

Vantaa East Vaccine Research Clinic, Vantaa

07100

Servizio di Igiene e Sanita Pubblica, Sassari

Azienda Ospedaliero Universitaria di Sassari, Sassari

31-202

oddzial Neuroinfekcji i Neurologii Dzieciecel, Krakowski Szpital Specjalistyczny im.J ana Pawla II, Krakow

Wojewodzka Poradnia Szczepien Ochronnych, Krakow

39-200

Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek, Dębica

55-093

NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin, Kiełczów

20-044

NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o., Lublin

NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o. ul., Lunlin

41-103

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska, Siemianowice Śląskie

50-452

NZOZ Praktyka Lekarza Rodzinnego Beata Stecka, Wroclaw

SO16 6YD

NIHR Wellcome Trust Clinical Research Facility, Southampton

BS2 8DX

University of Bristol, Clinical Research and Imaging Centre, Bristol

SW17 ORE

St. George's University of London**, London

OX3 7LE

Oxford Vaccine Group, University of Oxford, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY