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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01604746
First received: May 19, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes

May 19, 2012
April 23, 2013
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 ] [ Designated as safety issue: Yes ]
SAE = Serious adverse event, AESI = Adverse event of special interest
Same as current
Complete list of historical versions of study NCT01604746 on ClinicalTrials.gov 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
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1146
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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01604746
881201
Yes
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Gerald Aichinger, MD Baxter Innovations GmbH
Baxter Healthcare Corporation
April 2013

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