Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
This study has been completed.
Sponsor:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01604746
First received: May 19, 2012
Last updated: December 11, 2014
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prophylaxis of Ross River Virus Infection |
Biological: Ross River Virus (RRV) Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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) |
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]SAE = Serious adverse event, AESI = Adverse event of special interest
| Enrollment: | 1146 |
| Study Start Date: | July 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604746
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604746
Locations
| 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 | |
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
| Study Director: | Gerald Aichinger, MD | Baxter Innovations GmbH |
More Information
No publications provided
| Responsible Party: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT01604746 History of Changes |
| Other Study ID Numbers: | 881201 |
| Study First Received: | May 19, 2012 |
| Last Updated: | December 11, 2014 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
ClinicalTrials.gov processed this record on February 27, 2015