Clinical trial NCT01604746: Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prophylaxis of Ross River Virus Infection
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 1146
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 months after the third vaccination administered in precursor study 880801
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent´s Hospital
state: New South Wales
city: Westmead
country: Australia
facility: National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
state: New South Wales
city: Auchenflower
country: Australia
facility: Wesley Research Institute Clinical Trials Centre, The Wesley Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Base Hospital
state: Queensland
city: Herston
country: Australia
facility: QPID Clinical Trials Centre, Royal Children´s Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Dept of Microbiology & Infectious Diseases
state: South Australia
city: North Adelaide
country: Australia
facility: CMAX, a Division of the Institute of Drug Technology (IDT) Australia, Ltd.
state: South Australia
city: Geelong
country: Australia
facility: Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciencesl
state: Victoria
city: Heidelberg
country: Australia
facility: Centre for Clinical Studies
state: Victoria
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
Study officials:
affiliation: Baxter Innovations GmbH
name: Gerald Aichinger, MD
role: STUDY_DIRECTOR
References: