Prophylaxis of Ross River Virus Infection
Conditions
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.
Interventions
BIOLOGICALRoss River Virus (RRV) Vaccine
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
Sponsors
Alachua Government Services, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Outcome results
None listed