Sponsor study identifier
interventional
1,146
1 country
13
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 19, 2012
Actual (reported)May 24, 2012
Actual (reported)July 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 2013
Actual (reported)April 2013
Actual (reported)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
12 months after the third vaccination administered in precursor study 880801
Vaccine safety will be assessed in the period between 6 and 12 months after the 3rd vaccination in precursor Study 880801 based on diaries distributed to all subjects for documentation of SAEs or AESI. Females who became pregnant after the 3rd vaccination in Study 880801 will be followed until end of pregnancy.
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
St. Vincent´s Hospital
Darlinghurst, New South Wales, 2010, Australia
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
Westmead, New South Wales, 2145, Australia
Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
Auchenflower, Queensland, 4066, Australia
Cairns Base Hospital
Cairns, Queensland, 4870, Australia
QPID Clinical Trials Centre, Royal Children´s Hospital
Herston, Queensland, 4029, Australia
Gerald Aichinger, MD
Baxter Innovations GmbH
1,146 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2012
First Posted
May 24, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Dept of Microbiology & Infectious Diseases
Bedford Park, South Australia, 5042, Australia
CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
North Adelaide, South Australia, 5006, Australia
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
Geelong, Victoria, 3220, Australia
Centre for Clinical Studies
Heidelberg, Victoria, 3084, Australia
Emeritus Research
Malvern East, Victoria, 3145, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, 6840, Australia
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
October 9, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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