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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety assessment | No Intervention | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ross River Virus (RRV) Vaccine | Biological | Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subjects who participated in precursor Study 880801 and meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Aichinger, MD | Baxter Innovations GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holdsworth House Medical Practice | Darlinghurst | New South Wales | 2010 | Australia | ||
| St. Vincent´s Hospital |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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