344
Participants
Start Date
August 31, 2011
Primary Completion Date
December 31, 2011
Study Completion Date
December 31, 2011
Serogroup B meningococcal vaccine
"All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2.~A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination"
Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne, Melbourne
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre, Kippa-Ring
Royal Children's Hospital, Herston
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street, Sherwood
Women's and Children's Hospital, 72 King William Road, North Adelaide
Telethon Institute for Child Heath Research-cnr, Hamilton Street and Roberts Road-Subiaco
TASC Research Services, 1-15243 91st Avenue, Surrey
Colchester Regional Hospital Colchester Research Group, 68 Robie Street, Truro
Albion Finch Medical Centre, 1620 Albion Road, Suite 106, Etobicoke
Medicor Research Inc, 359 Riverside, Suite 200, Greater Sudbury
SKDS Research Inc, 221-679 Davis Dr.Newmarket, Toronto
Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540, Toronto
Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301, Woodstock
Lead Sponsor
Collaborators (1)
Novartis Vaccines
INDUSTRY
Novartis
INDUSTRY