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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00938639




Registration number
NCT00938639
Ethics application status
Date submitted
13/07/2009
Date registered
13/07/2009
Date last updated
25/04/2018

Titles & IDs
Public title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Scientific title
A Phase II, Single-centre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's Monovalent H1N1 Influenza Virus Vaccine in Healthy Adults Aged 18 to < 65 Years.
Secondary ID [1] 0 0
CSLCT-CAL-09-59
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza Caused by the Novel Influenza A (H1N1) Virus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CSL425
Other interventions - CSL425

Experimental: CSL425 (15 mcg) - 15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Experimental: CSL425 (30 mcg) - 30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21


Other interventions: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

Other interventions: CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)

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

Outcomes
Primary outcome [1] 0 0
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination - Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Timepoint [1] 0 0
Before and 21 days after the first vaccination
Primary outcome [2] 0 0
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination - Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Timepoint [2] 0 0
Before and 21 days after the second vaccination
Primary outcome [3] 0 0
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination - GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Timepoint [3] 0 0
Before and 21 days after the first vaccination
Primary outcome [4] 0 0
GMFI in the HI and MN Antibody Titer After the Second Vaccination - GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Timepoint [4] 0 0
Before and 21 days after the second vaccination
Primary outcome [5] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Timepoint [5] 0 0
21 days after the first vaccination
Primary outcome [6] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
Timepoint [6] 0 0
21 days after the second vaccination
Secondary outcome [1] 0 0
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group - Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Timepoint [1] 0 0
Before and 21 days after the first vaccination
Secondary outcome [2] 0 0
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group - Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Timepoint [2] 0 0
Before and 21 days after the second vaccination
Secondary outcome [3] 0 0
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group - GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Timepoint [3] 0 0
Before and 21 days after the first vaccination
Secondary outcome [4] 0 0
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group - GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Timepoint [4] 0 0
Before and 21 days after the second vaccination
Secondary outcome [5] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group - Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Timepoint [5] 0 0
21 days after the first vaccination
Secondary outcome [6] 0 0
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group - Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Timepoint [6] 0 0
21 days after the second vaccination
Secondary outcome [7] 0 0
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination - The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Timepoint [7] 0 0
Before and 21 days after each vaccination
Secondary outcome [8] 0 0
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination - The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination).
Timepoint [8] 0 0
Before and 21 days after each vaccination
Secondary outcome [9] 0 0
GMFI in the HI Antibody Titre 180 Days After the Second Vaccination - The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.
Timepoint [9] 0 0
21 days and 180 days after the second vaccination
Secondary outcome [10] 0 0
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
Timepoint [10] 0 0
180 days after the second vaccination
Secondary outcome [11] 0 0
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination - Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.
Timepoint [11] 0 0
From Day 0 to Day 6 after the first vaccination
Secondary outcome [12] 0 0
Duration of Solicited Local AEs After the First Vaccination - Solicited AEs included AEs that were specifically sought for.
Timepoint [12] 0 0
From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7
Secondary outcome [13] 0 0
Frequency and Intensity of Solicited Local AEs After the Second Vaccination - Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.
Timepoint [13] 0 0
From Day 0 to Day 6 after the second vaccination
Secondary outcome [14] 0 0
Duration of Solicited Local AEs After the Second Vaccination - Solicited AEs included AEs that were specifically sought for.
Timepoint [14] 0 0
From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7
Secondary outcome [15] 0 0
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination - Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.
Timepoint [15] 0 0
From Day 0 to Day 6 after the first vaccination
Secondary outcome [16] 0 0
Duration of Solicited Systemic AEs After the First Vaccination - Solicited AEs included AEs that were specifically sought for.
Timepoint [16] 0 0
From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7
Secondary outcome [17] 0 0
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination - Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.
Timepoint [17] 0 0
From Day 0 to Day 6 after the second vaccination
Secondary outcome [18] 0 0
Duration of Solicited Systemic AEs After the Second Vaccination - Solicited AEs included AEs that were specifically sought for.
Timepoint [18] 0 0
From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7
Secondary outcome [19] 0 0
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) - An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
Timepoint [19] 0 0
Up to 180 days after the last vaccination
Secondary outcome [20] 0 0
Frequency and Intensity of Unsolicited AEs - Unsolicited AEs included AEs other than those specifically sought for.
The grading definitions were:
Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.
Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.
Severe (Grade 3): Incapacitating, with inability to work or do usual activities.
Timepoint [20] 0 0
From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

Eligibility
Key inclusion criteria
- Male or female aged >= 18 to < 65 years at the time of providing informed consent.
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study
Vaccine.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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)
SA
Recruitment hospital [1] 0 0
Study Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for
eliciting an immune response to H1N1 influenza in healthy adults.
Trial website
https://clinicaltrials.gov/show/NCT00938639
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Director, Vaccines Clinical Development
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