Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

PHASE2CompletedINTERVENTIONAL
Enrollment

396

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

August 21, 2017

Study Completion Date

March 17, 2020

Conditions
Meningococcal B Disease
Interventions
BIOLOGICAL

rLP2086 vaccine

60 mcg or 120mcg at 0, 2 and 6 months

BIOLOGICAL

Pediatric HAV vaccine

0.5-mL dose at months 0 and 6. Normal saline at month 2.

Trial Locations (25)

2035

Australian Clinical Research Network (ACRN), Maroubra

Maroubra Medical Centre, Maroubra

2605

The Canberra Hospital, Canberra, Garran

3052

Murdoch Children's Research Institute, Parkville

5006

Women's And Children's Hospital, North Adelaide

6009

Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital, Nedlands

20520

Turku Vaccine Research Clinic, Turku

28100

Pori Vaccine Research Clinic, Pori

33100

Tampere Vaccine Research Clinic, Tampere

377 01

Ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

Samostatna ordinace praktickeho lekare pro deti a dorost, Jindřichův Hradec

160 00

Medicentrum 6 s.r.o, Praha 6 - Vokovice

257 41

Prakticky Lekar Pro Deti A Mladez, Týnec nad Sázavou

02230

Espoo Vaccine Research Clinic, Espoo

00100

Helsinki South Vaccine Research Clinic, Helsinki

00930

Helsinki East Vaccine Research Clinic, Helsinki

04400

Jarvenpaa Vaccine Research Center, Järvenpää

85-079

NZOZ Vitamed, Bydgoszcz

39-200

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

31-302

Indywidualna Specjalistyczna Praktyka Lekarska Hanna Czajka, Krakow

91-347

Specjalistyczna Praktyka Lekarska GRAVITA, Lodz

20-044

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

41-103

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska, Siemianowice Śląskie

55-100

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

50-368

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Klinika Pediatrii i Chorob, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY