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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00562484
Registration number
NCT00562484
Ethics application status
Date submitted
20/11/2007
Date registered
22/11/2007
Date last updated
21/11/2017
Titles & IDs
Public title
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
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Scientific title
A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged = 18 to < 65 Years.
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Secondary ID [1]
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CSLCT-USF-06-28
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Universal Trial Number (UTN)
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Trial acronym
CSL's IVV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - CSL Limited Influenza Vaccine
Treatment: Other - Placebo
Experimental: 1 -
Other: 2 -
Treatment: Other: CSL Limited Influenza Vaccine
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
Treatment: Other: Placebo
Placebo
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
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Assessment method [1]
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Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.
Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.
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Timepoint [1]
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2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
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Secondary outcome [1]
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CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains
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Assessment method [1]
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Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.
Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate.
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Timepoint [1]
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2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
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Secondary outcome [2]
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Incidence of Influenza-like Illness (ILI)
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Assessment method [2]
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The criteria for the protocol defined ILI were as follows:
* At least one respiratory symptom:
* cough, sore throat or nasal congestion
* And at least one systemic symptom:
* fever (as defined by oral temperature = 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches.
The CDC ILI case definition was the occurrence of fever (100°F \[37.8°C\] or higher) in conjunction with either cough or sore throat.
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Timepoint [2]
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2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
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Secondary outcome [3]
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Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
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Assessment method [3]
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Timepoint [3]
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21 days after study vaccination
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Secondary outcome [4]
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Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
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Assessment method [4]
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Timepoint [4]
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21 days after study vaccination
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Secondary outcome [5]
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Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
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Assessment method [5]
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Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer = 1:40 or a pre-vaccination titer = 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
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Timepoint [5]
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21 days after study vaccination
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Secondary outcome [6]
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Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
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Assessment method [6]
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Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer = 1:40 or a pre-vaccination titer = 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
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Timepoint [6]
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21 days after study vaccination
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Secondary outcome [7]
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Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
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Assessment method [7]
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Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
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Timepoint [7]
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21 days after study vaccination
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Secondary outcome [8]
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Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
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Assessment method [8]
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Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
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Timepoint [8]
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21 days after study vaccination
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Secondary outcome [9]
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Frequency and Intensity of Local and Systemic Solicited Symptoms
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Assessment method [9]
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Adverse event grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Fever Grade 1: = 37.7°C - \< 38.0°C (= 99.9 - \< 100.4°F) Grade 2: = 38.0°C - \< 39.0°C (= 100.4 - \< 102.2°F) Grade 3: = 39.0°C (\> 102.2°F)
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Timepoint [9]
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5 days after study vaccination
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Secondary outcome [10]
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Frequency and Intensity of Unsolicited Adverse Events (UAEs)
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Assessment method [10]
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UAE grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities.
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Timepoint [10]
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21 days after study vaccination
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Secondary outcome [11]
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Serious Adverse Events (SAEs)
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Assessment method [11]
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An SAE was any untoward medical occurrence that at any dose:
* Resulted in death;
* Was life-threatening;
* Required an unexpected in-participant hospitalization or prolongation of existing hospitalization;
* Resulted in persistent or significant disability / incapacity;
* Was a congenital anomaly / birth defect; and / or
* Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out
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Timepoint [11]
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180 days after study vaccination
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Secondary outcome [12]
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New Onsets of Chronic Illness (NOCI)
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Assessment method [12]
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An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
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Timepoint [12]
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180 days after study vaccination
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Eligibility
Key inclusion criteria
* Healthy males and females aged = 18 to < 65 years at the time of vaccination
* Non pregnant/ non lactating females
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
* Vaccination against influenza in the previous 6 months
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
* Known history of Guillain-Barré Syndrome;
* Clinical signs of active infection and/or an oral temperature of = 37.8 oC.
* History of neurological disorders or seizures
* Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
* Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
* Administration of immunoglobulins and/or any blood products;
* Participation in a clinical trial or use of an investigational compound;
* Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
* Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2010
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Sample size
Target
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Accrual to date
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Final
7500
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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The Clinical Trials Unit, Canberra Hospital - Canberra
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Recruitment hospital [2]
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Australian Clinical Research Organisation - Brookvale
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Recruitment hospital [3]
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Australian Clinical Research Organisation - Caringbah
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Recruitment hospital [4]
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Eastern Area Health Service, Prince of Wales Hospital - Randwick
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Recruitment hospital [5]
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National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead - Westmead
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Recruitment hospital [6]
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Australian Clinical Research Organisation - Auchenflower
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Recruitment hospital [7]
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Trialworks Clinical Research Services - Brisbane
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Recruitment hospital [8]
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Australian Clinical Research Organisation Caboolture Clinical Research Centre - Caboolture
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Recruitment hospital [9]
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School of Medicine, James Cook University, Cairns Base Hospital - Cairns
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Recruitment hospital [10]
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Gold Coast Hospital - Gold Coast
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Recruitment hospital [11]
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Australian Clinical Research Organisation - Kippa Ring
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Recruitment hospital [12]
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CMAX, a division of IDT Australia - Adelaide
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Recruitment hospital [13]
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Paediatric Trials Unit, Women's and Children's Hospital - Adelaide
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Recruitment hospital [14]
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Primary Old Port Road Medical and Dental Centre - Royal Park
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Recruitment hospital [15]
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Sexual Health Service - Hobart
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Recruitment hospital [16]
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Barwon Health, Geelong Hospital - Geelong
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Recruitment hospital [17]
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Emeritus Research - Malvern East
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Recruitment hospital [18]
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Murdoch Childrens Research Institute - Melbourne
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Recruitment hospital [19]
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Lung Institute of Western Australia - Perth
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Recruitment hospital [20]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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- Canberra
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Recruitment postcode(s) [2]
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- Brookvale
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Recruitment postcode(s) [3]
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- Caringbah
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Recruitment postcode(s) [4]
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- Randwick
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Recruitment postcode(s) [5]
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- Westmead
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Recruitment postcode(s) [6]
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4066 - Auchenflower
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Recruitment postcode(s) [7]
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- Brisbane
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Recruitment postcode(s) [8]
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4510 - Caboolture
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Recruitment postcode(s) [9]
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- Cairns
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Recruitment postcode(s) [10]
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- Gold Coast
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Recruitment postcode(s) [11]
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- Kippa Ring
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Recruitment postcode(s) [12]
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- Adelaide
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Recruitment postcode(s) [13]
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5014 - Royal Park
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Recruitment postcode(s) [14]
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- Hobart
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Recruitment postcode(s) [15]
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- Geelong
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Recruitment postcode(s) [16]
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- Malvern East
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Recruitment postcode(s) [17]
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- Melbourne
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Recruitment postcode(s) [18]
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- Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Dunedin
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seqirus
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.
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Trial website
https://clinicaltrials.gov/study/NCT00562484
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Trial related presentations / publications
Mcbride WJH, Abhayaratna WP, Barr I, Booy R, Carapetis J, Carson S, De Looze F, Ellis-Pegler R, Heron L, Karrasch J, Marshall H, Mcvernon J, Nolan T, Rawlinson W, Reid J, Richmond P, Shakib S, Basser RL, Hartel GF, Lai MH, Rockman S, Greenberg ME. Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial. Vaccine. 2016 Sep 22;34(41):4991-4997. doi: 10.1016/j.vaccine.2016.08.038. Epub 2016 Aug 29.
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Public notes
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Contacts
Principal investigator
Name
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Clinical Director Vaccines
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Address
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Seqirus
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00562484
Download to PDF