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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01604746




Registration number
NCT01604746
Ethics application status
Date submitted
19/05/2012
Date registered
24/05/2012
Date last updated
9/10/2015

Titles & IDs
Public title
Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
Scientific 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)
Secondary ID [1] 0 0
881201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis of Ross River Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ross River Virus (RRV) Vaccine

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.


Other interventions: Ross River Virus (RRV) Vaccine
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 months after the third vaccination administered in precursor study 880801

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
1146
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
St. Vincent´s Hospital - Darlinghurst
Recruitment hospital [3] 0 0
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead - Westmead
Recruitment hospital [4] 0 0
Wesley Research Institute Clinical Trials Centre, The Wesley Hospital - Auchenflower
Recruitment hospital [5] 0 0
Cairns Base Hospital - Cairns
Recruitment hospital [6] 0 0
QPID Clinical Trials Centre, Royal Children´s Hospital - Herston
Recruitment hospital [7] 0 0
Dept of Microbiology & Infectious Diseases - Bedford Park
Recruitment hospital [8] 0 0
CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd. - North Adelaide
Recruitment hospital [9] 0 0
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl - Geelong
Recruitment hospital [10] 0 0
Centre for Clinical Studies - Heidelberg
Recruitment hospital [11] 0 0
Emeritus Research - Malvern East
Recruitment hospital [12] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [13] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5006 - North Adelaide
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3145 - Malvern East
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6840 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ology Bioservices
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01604746
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald Aichinger, MD
Address 0 0
Baxter Innovations GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01604746