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)

NCT01604746 Phase 3 COMPLETED

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.

Details

Lead sponsor	Alachua Government Services, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	1146
Start date	2012-07
Completion	2013-04

Conditions

• Prophylaxis of Ross River Virus Infection

Interventions

• Ross River Virus (RRV) Vaccine

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

Countries

Australia