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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01604746
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):
Nanotherapeutics, Inc.

May 19, 2012
May 24, 2012
October 9, 2015
July 2012
April 2013   (Final data collection date for primary outcome 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 [ Time Frame: 12 months after the third vaccination administered in precursor study 880801 ]
SAE = Serious adverse event, AESI = Adverse event of special interest
Same as current
Complete list of historical versions of study NCT01604746 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801
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)
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.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Prophylaxis of Ross River Virus Infection
Biological: Ross River Virus (RRV) Vaccine
Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
No Intervention: Safety assessment
Vaccine safety will be assessed in the period between 6 and 12 months after the 3rd vaccination in precursor Study 880801 based on diaries distributed to all subjects for documentation of SAEs or AESI. Females who became pregnant after the 3rd vaccination in Study 880801 will be followed until end of pregnancy.
Intervention: Biological: Ross River Virus (RRV) Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
Not Provided
Study Director: Gerald Aichinger, MD Baxter Innovations GmbH
Nanotherapeutics, Inc.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP