Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
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ClinicalTrials.gov Identifier: NCT01604746 |
Recruitment Status
:
Completed
First Posted
: May 24, 2012
Last Update Posted
: October 9, 2015
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Condition or disease | Intervention/treatment | Phase |
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Prophylaxis of Ross River Virus Infection | Biological: Ross River Virus (RRV) Vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1146 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Open-label Phase 3b Study to Investigate the Safety of Ross River Virus (RRV) Vaccine From 6 to 12 Months After the Third Vaccination in Healthy Adults (Follow up to Precursor Study 880801) |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |
Arm | Intervention/treatment |
---|---|
No Intervention: Safety assessment
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.
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Biological: Ross River Virus (RRV) Vaccine
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
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- 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 [ Time Frame: 12 months after the third vaccination administered in precursor study 880801 ]SAE = Serious adverse event, AESI = Adverse event of special interest

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects who participated in precursor Study 880801 and meet all of the following criteria:
- Subject received 3 RRV vaccinations in Study 880801
- Subject has completed Visit 6 in Study 880801
- Subject and, if applicable, subject´s parent(s)/legal guardian(s), understand the nature of the study and its procedures, agree to its provisions and provide written informed consent prior to study entry
- Subject provides written assent according to his/her age, if applicable
Exclusion Criteria:
- Subject has participated in another clinical study other than Study 880801 involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604746
Australia, New South Wales | |
Holdsworth House Medical Practice | |
Darlinghurst, New South Wales, Australia, 2010 | |
St. Vincent´s Hospital | |
Darlinghurst, New South Wales, Australia, 2010 | |
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead | |
Westmead, New South Wales, Australia, 2145 | |
Australia, Queensland | |
Wesley Research Institute Clinical Trials Centre, The Wesley Hospital | |
Auchenflower, Queensland, Australia, 4066 | |
Cairns Base Hospital | |
Cairns, Queensland, Australia, 4870 | |
QPID Clinical Trials Centre, Royal Children´s Hospital | |
Herston, Queensland, Australia, 4029 | |
Australia, South Australia | |
Dept of Microbiology & Infectious Diseases | |
Bedford Park, South Australia, Australia, 5042 | |
CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd. | |
North Adelaide, South Australia, Australia, 5006 | |
Australia, Victoria | |
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl | |
Geelong, Victoria, Australia, 3220 | |
Centre for Clinical Studies | |
Heidelberg, Victoria, Australia, 3084 | |
Emeritus Research | |
Malvern East, Victoria, Australia, 3145 | |
Australia, Western Australia | |
Linear Clinical Research | |
Nedlands, Western Australia, Australia, 6009 | |
Princess Margaret Hospital for Children | |
Perth, Western Australia, Australia, 6840 |
Study Director: | Gerald Aichinger, MD | Baxter Innovations GmbH |
Responsible Party: | Nanotherapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01604746 History of Changes |
Other Study ID Numbers: |
881201 |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | October 9, 2015 |
Last Verified: | October 2015 |
Additional relevant MeSH terms:
Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |