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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Prophylaxis of Ross River Virus Infection	Biological: Ross River Virus (RRV) Vaccine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1146 participants
Intervention Model:	Single Group Assignment
Masking:	None (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)
Study Start Date :	July 2012
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Australia, New South Wales
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
St. Vincent´s Hospital
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

Nanotherapeutics, Inc.

Investigators

Study Director:	Gerald Aichinger, MD	Baxter Innovations GmbH

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01604746 History of Changes
Other Study ID Numbers:	881201
First Posted:	May 24, 2012
Last Update Posted:	October 9, 2015
Last Verified:	October 2015

Additional relevant MeSH terms:

Virus Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs