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Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801

Primary Purpose

Prophylaxis of Ross River Virus Infection

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Ross River Virus (RRV) Vaccine
Sponsored by
Ology Bioservices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis of Ross River Virus Infection

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Holdsworth House Medical Practice
  • St. Vincent´s Hospital
  • National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
  • Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
  • Cairns Base Hospital
  • QPID Clinical Trials Centre, Royal Children´s Hospital
  • Dept of Microbiology & Infectious Diseases
  • CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
  • Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
  • Centre for Clinical Studies
  • Emeritus Research
  • Linear Clinical Research
  • Princess Margaret Hospital for Children

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Safety assessment

Arm Description

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.

Outcomes

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
SAE = Serious adverse event, AESI = Adverse event of special interest

Secondary Outcome Measures

Full Information

First Posted
May 19, 2012
Last Updated
October 7, 2015
Sponsor
Ology Bioservices
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1. Study Identification

Unique Protocol Identification Number
NCT01604746
Brief Title
Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ology Bioservices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis of Ross River Virus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety assessment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Ross River Virus (RRV) Vaccine
Intervention Description
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
Primary Outcome Measure Information:
Title
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
Description
SAE = Serious adverse event, AESI = Adverse event of special interest
Time Frame
12 months after the third vaccination administered in precursor study 880801

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Aichinger, MD
Organizational Affiliation
Baxter Innovations GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. Vincent´s Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Cairns Base Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
QPID Clinical Trials Centre, Royal Children´s Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Dept of Microbiology & Infectious Diseases
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Centre for Clinical Studies
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Emeritus Research
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6840
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801

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