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

Phase 3

Completed

• Conditions: Prophylaxis of Ross River Virus Infection
• Interventions: Biological: Ross River Virus (RRV) Vaccine

• Registration Number: NCT01604746
• Lead Sponsor: Resilience Government Services, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-19
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-24
• Study Start: 2012-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1146

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Safety assessment	Ross River Virus (RRV) Vaccine	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.

Primary Outcome Measures

Name	Time	Method
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	12 months after the third vaccination administered in precursor study 880801	SAE = Serious adverse event, AESI = Adverse event of special interest

Trial Locations

Locations (13)

St. Vincent´s Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Holdsworth House Medical Practice; 🇦🇺 Darlinghurst, New South Wales, Australia

National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead; 🇦🇺 Westmead, New South Wales, Australia

Wesley Research Institute Clinical Trials Centre, The Wesley Hospital; 🇦🇺 Auchenflower, Queensland, Australia

Cairns Base Hospital; 🇦🇺 Cairns, Queensland, Australia

QPID Clinical Trials Centre, Royal Children´s Hospital; 🇦🇺 Herston, Queensland, Australia

Dept of Microbiology & Infectious Diseases; 🇦🇺 Bedford Park, South Australia, Australia

Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl; 🇦🇺 Geelong, Victoria, Australia

Centre for Clinical Studies; 🇦🇺 Heidelberg, Victoria, Australia

Emeritus Research; 🇦🇺 Malvern East, Victoria, Australia

Princess Margaret Hospital for Children; 🇦🇺 Perth, Western Australia, 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