Status:
COMPLETED
Ross River Virus (RRV) Vaccine Study
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Prophylaxis of Ross River Virus Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to verify the safety and adequacy of the immune response produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to demonstrate th...
Eligibility Criteria
Inclusion
- Subject is 16 to 59 years of age on the day of screening (for Stratum A only)
- Subject is 60 years of age or older on the day of screening (for Stratum B only)
- Subject and, if applicable, subject's parent(s)/legal guardian(s) has (/have) an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
- Subject provides written assent according to his/her age, if applicable
- Subject is generally healthy as determined by the investigator's clinical judgment based upon medical history and physical examination
- Subject is physically and mentally capable of participating in the study and following study procedures
- Subject agrees to keep a daily record of symptoms for the duration of the study
- If female of childbearing potential - subject has a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study
Exclusion
- Subject has a Body Mass Index \> 35.0
- Subject has an elevated blood pressure at screening of \> 159 mmHg systolic and/or \> 99 mmHg diastolic while seated and at rest and confirmed by 2 additional measurements taken at least 30 minutes apart (while seated and at rest)
- Subject has any inherited or acquired immune deficiency
- Subject has or has a recent history of significant neurological, cardiovascular, respiratory (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
- Subject has a history of arthritis (including RRV disease, joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months
- Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\> 800 μg/day of beclomethasone dipropionate or equivalent), corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
- Subjects has received any vaccination within 30 days prior to study entry
- Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
- Subject has donated blood or plasma within 30 days prior to study entry
- Subject has a history of any vaccine related contraindicating event (eg, anaphylaxis, allergy to components of the test vaccine, other known contraindications)
- Subject has a dermatologic condition or tattoos which may interfere with injection site reaction rating
- Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to enrollment in this study or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
- Subject has functional or surgical asplenia
- Subject has a known or suspected problem with alcohol or drug abuse
- Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting this study
- Subject is pregnant or lactating
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1968 Patients enrolled
Trial Details
Trial ID
NCT01242670
Start Date
April 1 2011
End Date
October 1 2012
Last Update
October 9 2015
Active Locations (17)
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1
Holdsworth House
Byron Bay, New South Wales, Australia, 2481
2
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010
3
St. Vincents Hospital
Darlinghurst, New South Wales, Australia, 2010
4
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
Westmead, New South Wales, Australia, 2145