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

Prophylaxis of Ross River Virus Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604746
• Other study ID #: 881201
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2012
• Last updated: October 7, 2015
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2015
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1146
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prophylaxis of Ross River Virus Infection
• Virus Diseases

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes