NCT01604746
Completed
Phase 3
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)
Resilience Government Services, Inc.13 sites in 1 country1,146 target enrollmentStarted: July 2012Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,146
- Locations
- 13
- Primary Endpoint
- 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
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (13)
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