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Completed

NCT Number: NCT01604746

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

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.

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Key information

Conditions

Prophylaxis of Ross River Virus Infection

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Holdsworth House Medical Practice, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ross River Virus (RRV) Vaccine

Biological

Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 24, 2012
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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