1,630
Participants
Start Date
March 1, 2011
Primary Completion Date
September 13, 2011
Study Completion Date
February 28, 2014
Multivalent recombinant OspA Lyme Borreliosis Vaccine
Primary vaccination (6 study arms of 50 subjects each): 3 intramuscular injections containing either dose A, B or C in an adjuvanted or non-adjuvanted formulation (6 different formulations) given in monthly intervals (recruited in 3 sequential cohorts)
Multivalent recombinant OspA Lyme Borreliosis Vaccine
Booster vaccination 9-12 months after first vaccination in Section 1 subjects
Multivalent recombinant OspA Lyme Borreliosis Vaccine
3 intramuscular injections at monthly intervals (using 2 formulations selected from Section 1) in seronegative and seropositive subjects (N=350) and a booster vaccination at 6 months or at 9-12 months (Cohorts 4: seronegatives; Cohort 5: seropositives)
Medical University Vienna, Dept. of Clinical Pharmacology, Vienna
Zentrum für Reisemedizin (Center for Travel Medicine), Vienna
Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT), Berlin
Internistische Gemeinschaftspraxis (Internal Medicine Group Practice), Mainz
Innomed Dr. Naudts Klinische Forschung, Rodgau
Universitätsklinikum Tübingen, Abtlg. Tropenmedizin, Tübingen
Hautarztpraxis Cutanis (Dermatologist), Freiburg im Breisgau
GWT-TUD GmbH, Dresden
Collaborators (1)
Baxter Innovations GmbH
INDUSTRY
Baxalta now part of Shire
INDUSTRY