The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,146
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
St. Vincent´s Hospital
Darlinghurst, New South Wales, Australia
Incidence of SAEs and AESI, such as arthritis, Guillain Barré Syndrome (GBS), encephalitis, convulsions, Bell´s palsy, neuritis, vasculitis, demyelinating disorders (ADEM and myelitis) and vaccination failure
SAE = Serious adverse event, AESI = Adverse event of special interest
Time frame: 12 months after the third vaccination administered in precursor study 880801
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National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
Westmead, New South Wales, Australia
Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
Auchenflower, Queensland, Australia
Cairns Base Hospital
Cairns, Queensland, Australia
QPID Clinical Trials Centre, Royal Children´s Hospital
Herston, Queensland, Australia
Dept of Microbiology & Infectious Diseases
Bedford Park, South Australia, Australia
CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
North Adelaide, South Australia, Australia
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
Geelong, Victoria, Australia
Centre for Clinical Studies
Heidelberg, Victoria, Australia
...and 3 more locations