Prophylaxis of Ross River Virus InfectionPhase 3NCT01604746
Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
A Phase 3 study testing Ross River Virus (RRV) Vaccine in people with Prophylaxis of Ross River Virus Infection, run by Alachua Government Services, Inc. at 13 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis of Ross River Virus Infection
- What is being tested?
- Ross River Virus (RRV) Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,146 participants
- Where
- 13 sitesAustralia
- Study dates
- Jul 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
Auchenflower, Queensland, 4066
Dept of Microbiology & Infectious Diseases
Bedford Park, South Australia, 5042
Cairns Base Hospital
Cairns, Queensland, 4870
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010
St. Vincent´s Hospital
Darlinghurst, New South Wales, 2010
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
Geelong, Victoria, 3220
Centre for Clinical Studies
Heidelberg, Victoria, 3084
QPID Clinical Trials Centre, Royal Children´s Hospital
Herston, Queensland, 4029
Emeritus Research
Malvern East, Victoria, 3145
Linear Clinical Research
Nedlands, Western Australia, 6009
CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
North Adelaide, South Australia, 5006
Princess Margaret Hospital for Children
Perth, Western Australia, 6840
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
Westmead, New South Wales, 2145
About this study
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)
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.
- Being tested
- Ross River Virus (RRV) Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ross River Virus (RRV) VaccineBiological
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Ross River Virus (RRV) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after the third vaccination administered in precursor study 880801
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis of Ross River Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerald Aichinger, MD, Study director, Baxter Innovations GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604746
- Sponsor's protocol ID
- 881201
- Status last verified
- Oct 2015
- First submitted
- 19 May 2012
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01604746
- Acronym / sponsor ID
- 881201
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety assessment | No intervention | Biological: Ross River Virus (RRV) VaccineVaccine 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ross River Virus (RRV) VaccineNot applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study. | Biological | Safety assessment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Aichinger, MD study director
Baxter Innovations GmbH
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ross River Virus (RRV) Vaccine in people with Prophylaxis of Ross River Virus Infection, run by Alachua Government Services, Inc. at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.