A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

PHASE3CompletedINTERVENTIONAL
Enrollment

5,715

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Meningitis, Meningococcal
Interventions
BIOLOGICAL

rLP2086 vaccine

120 mcg, 3 doses, at month 0, 2, and 6.

BIOLOGICAL

control

HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Trial Locations (86)

2035

Australian Clinical Research Network, Maroubra

2145

The Children's Hospital at Westmead, Westmead

4075

AusTrials Pty Ltd, Sherwood

5006

Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics, North Adelaide

6008

Telethon Institute for Child Health Research, Subiaco

8200

Aarhus Universitetshospital, Skejby, Aarhus N

10117

Innomedica OU, Tallinn

10617

Merekivi Perearstid OU, Tallinn

Merelahe Family Doctors Centre, Tallinn

14609

Rochester Clinical Research, Inc., Rochester

20246

Clinical Trial Center North, Hamburg

20251

Clinical Trial Center North GmbH & Co.KG, Hamburg

20359

Bernhard Nocht Centre for Clinical Trials (BNCCT), Hamburg

20520

Turku Vaccine Research Clinic, Turku

22015

PI-Coor Clinical Research, LLC, Burke

22902

Pediatric Research of Charlottesville, Charlottesville

28100

Pori Vaccine Research Clinic, Pori

29464

Coastal Carolina Research Center, Mt. Pleasant

30138

Ordinace praktickeho lekare pro deti a dorost, Pilsen

32216

Jacksonville Center for Clinical Research, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

32934

Optimal Research, LLC, Melbourne

32935

Accelovance, Melbourne

33100

Tampere Vaccine Research Clinic, Tampere

33143

Miami Research Associates, South Miami

35802

Accelovance,Inc., Huntsville

37620

PMG Research of Bristol, Bristol

37701

Samostatna ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

40004

Kentucky Pediatric/Adult Research, Bardstown

41014

Instituto Hispalense de Pediatria, Seville

44122

Rapid Medical Research. Inc., Cleveland

44316

Eraarst Kersti Veidrik Ou, Rakvere

45414

Ohio Pediatric Research Association, Dayton

46001

Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir, Valencia

46545

Accelovance,Inc., Mishawaka

48259

"JSC InMedica", Kaunas

51503

Clinical Research Advantage,Inc/Ridge Family Practice, Council Bluffs

68025

Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP, Fremont

Prairie Fields Family Medicine/Clinical Research Advantage, Fremont

72432

Harrisburg Family Medical Center, Harrisburg

75234

Research Across America, Dallas

76135

Benchmark Research, Fort Worth

77055

West Houston Clinical Research Service, Houston

77450

Research Across America, Katy

78229

Clinical Trials of Texas, Inc., San Antonio

78705

Benchmark Research, Austin

78745

Tekton Research, Austin

84088

Advanced Clinical Research, West Jordan

84095

J. Lewis Research, Inc. - Jordan River Family Medicine, South Jordan

84109

J. Lewis Research, Inc. - Foothill Family Clinic, Salt Lake City

84121

J. Lewis Research, Inc. / Foothill Family Clinic South, Salt Lake City

84124

Jean Brown Research, Salt Lake City

85224

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC, Chandler

Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC, Chandler

85282

Cassidy Medical Group/Clinical Research Advantage, Tempe

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC, Tempe

Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address, Tempe

90185

Norrlands Universitetssjukhus, Institution för Pediatrik, Umeå

92083

Cassidy Medical Group/Clinical Research Advantage, Vista

92108

Accelovance. Inc, San Diego

94102

Benchmark Research, San Francisco

97070

Juliusspital Wuerzburg, Würzburg

886000

Centro de Estudios de Vacunas, CESFAM Gabriela Mistral, Santiago

4781156

Centro De Investigacion Clinica Del Sur, Temuco

7500539

Hospital Luis Calvo Mackenna, Santiago

8330034

Hospital Clinico de la Pontificia Universidad Catolica de Chile/, Santiago

8550442

Cesfam Dr. Jose Symon Ojeda, Conchalí

377 01

Ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

Samostatna ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

120 00

Ordinace praktickeho lekare pro deti a dorost, Prague

257 41

Prakticky Lekar Pro Deti a Mladez, Týnec nad Sázavou

LT-49449

Saules Family Medicine Centre, Kaunas

LT47116

Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases, Kaunas

LT50009

LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE, Kaunas

LT01117

Centro poliklinika, Public Institution, Vilnius

31-202

Krakowski Szpital Specjalistyczny im Jana Pawla II, Krakow

39-200

Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek, Dębica

31-302

Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska, Krakow

21-100

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny, Lubartów

55-120

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak, Oborniki Śląskie

61-709

Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu, Poznan

41-103

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska, Siemianowice Śląskie

87-100

NZOZ Nasz Lekarz, Torun

55-100

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny, Trzebnica

50-345

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw

205 02

Vaccinenheten Barn- och ungdomsmedicinska kliniken, Malmo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01352793 - A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years | Biotech Hunter | Biotech Hunter