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

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.

Study Overview

• Status: Completed
• Conditions: Prophylaxis of Ross River Virus Infection
• Intervention / Treatment: Biological: Ross River Virus (RRV) Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1146
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Darlinghurst, New South Wales, Australia, 2010
      • St. Vincent´s Hospital
    • Westmead, New South Wales, Australia, 2145
      • National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
    • Cairns, Queensland, Australia, 4870
      • Cairns Base Hospital
    • Herston, Queensland, Australia, 4029
      • QPID Clinical Trials Centre, Royal Children´s Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Dept of Microbiology & Infectious Diseases
    • North Adelaide, South Australia, Australia, 5006
      • CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
    • Heidelberg, Victoria, Australia, 3084
      • Centre for Clinical Studies
    • Malvern East, Victoria, Australia, 3145
      • Emeritus Research
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research
    • Perth, Western Australia, Australia, 6840
      • Princess Margaret Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ology Bioservices
• Investigators: Study Director: Gerald Aichinger, MD, Baxter Innovations GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: May 19, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (ESTIMATE): May 24, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 9, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Togaviridae Infections; Alphavirus Infections
• Other Study ID Numbers: 881201