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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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.
Secondary ID [1] 0 0
CSLCT-USF-06-28
Universal Trial Number (UTN)
Trial acronym
CSL's IVV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CSL Limited Influenza Vaccine
Other interventions - Placebo

Experimental: 1 -

Other: 2 -


Other interventions: CSL Limited Influenza Vaccine
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.

Other interventions: Placebo
Placebo

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection - 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.
Timepoint [1] 0 0
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary outcome [1] 0 0
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 - 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.
Timepoint [1] 0 0
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary outcome [2] 0 0
Incidence of Influenza-like Illness (ILI) - 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.
Timepoint [2] 0 0
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary outcome [3] 0 0
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
Timepoint [3] 0 0
21 days after study vaccination
Secondary outcome [4] 0 0
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
Timepoint [4] 0 0
21 days after study vaccination
Secondary outcome [5] 0 0
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 - 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.
Timepoint [5] 0 0
21 days after study vaccination
Secondary outcome [6] 0 0
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 - 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.
Timepoint [6] 0 0
21 days after study vaccination
Secondary outcome [7] 0 0
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 - Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Timepoint [7] 0 0
21 days after study vaccination
Secondary outcome [8] 0 0
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 - Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Timepoint [8] 0 0
21 days after study vaccination
Secondary outcome [9] 0 0
Frequency and Intensity of Local and Systemic Solicited Symptoms - 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)
Timepoint [9] 0 0
5 days after study vaccination
Secondary outcome [10] 0 0
Frequency and Intensity of Unsolicited Adverse Events (UAEs) - 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.
Timepoint [10] 0 0
21 days after study vaccination
Secondary outcome [11] 0 0
Serious Adverse Events (SAEs) - 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
Timepoint [11] 0 0
180 days after study vaccination
Secondary outcome [12] 0 0
New Onsets of Chronic Illness (NOCI) - 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).
Timepoint [12] 0 0
180 days after study vaccination

Eligibility
Key inclusion criteria
- Healthy males and females aged = 18 to < 65 years at the time of vaccination

- Non pregnant/ non lactating females
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Clinical Trials Unit, Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Australian Clinical Research Organisation - Brookvale
Recruitment hospital [3] 0 0
Australian Clinical Research Organisation - Caringbah
Recruitment hospital [4] 0 0
Eastern Area Health Service, Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead - Westmead
Recruitment hospital [6] 0 0
Australian Clinical Research Organisation - Auchenflower
Recruitment hospital [7] 0 0
Trialworks Clinical Research Services - Brisbane
Recruitment hospital [8] 0 0
Australian Clinical Research Organisation Caboolture Clinical Research Centre - Caboolture
Recruitment hospital [9] 0 0
School of Medicine, James Cook University, Cairns Base Hospital - Cairns
Recruitment hospital [10] 0 0
Gold Coast Hospital - Gold Coast
Recruitment hospital [11] 0 0
Australian Clinical Research Organisation - Kippa Ring
Recruitment hospital [12] 0 0
CMAX, a division of IDT Australia - Adelaide
Recruitment hospital [13] 0 0
Paediatric Trials Unit, Women's and Children's Hospital - Adelaide
Recruitment hospital [14] 0 0
Primary Old Port Road Medical and Dental Centre - Royal Park
Recruitment hospital [15] 0 0
Sexual Health Service - Hobart
Recruitment hospital [16] 0 0
Barwon Health, Geelong Hospital - Geelong
Recruitment hospital [17] 0 0
Emeritus Research - Malvern East
Recruitment hospital [18] 0 0
Murdoch Childrens Research Institute - Melbourne
Recruitment hospital [19] 0 0
Lung Institute of Western Australia - Perth
Recruitment hospital [20] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Brookvale
Recruitment postcode(s) [3] 0 0
- Caringbah
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment postcode(s) [8] 0 0
4510 - Caboolture
Recruitment postcode(s) [9] 0 0
- Cairns
Recruitment postcode(s) [10] 0 0
- Gold Coast
Recruitment postcode(s) [11] 0 0
- Kippa Ring
Recruitment postcode(s) [12] 0 0
- Adelaide
Recruitment postcode(s) [13] 0 0
5014 - Royal Park
Recruitment postcode(s) [14] 0 0
- Hobart
Recruitment postcode(s) [15] 0 0
- Geelong
Recruitment postcode(s) [16] 0 0
- Malvern East
Recruitment postcode(s) [17] 0 0
- Melbourne
Recruitment postcode(s) [18] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00562484
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Director Vaccines
Address 0 0
Seqirus
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications