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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01604746
First received: May 19, 2012
Last updated: April 23, 2013
Last verified: April 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
Australia, New South Wales
St. Vincent´s Hospital
Darlinghurst, New South Wales, Australia, 2010
Holdsworth House Medical Practice
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: April 23, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014