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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00938639
Registration number
NCT00938639
Ethics application status
Date submitted
13/07/2009
Date registered
14/07/2009
Date last updated
28/06/2018
Titles & IDs
Public title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
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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.
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Secondary ID [1]
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CSLCT-CAL-09-59
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza Caused by the Novel Influenza A (H1N1) Virus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Other interventions
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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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Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
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Assessment method [1]
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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.
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Timepoint [1]
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Before and 21 days after the first vaccination
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Primary outcome [2]
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HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
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Assessment method [2]
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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.
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Timepoint [2]
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Before and 21 days after the second vaccination
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Primary outcome [3]
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Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
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Assessment method [3]
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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.
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Timepoint [3]
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Before and 21 days after the first vaccination
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Primary outcome [4]
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GMFI in the HI and MN Antibody Titer After the Second Vaccination
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Assessment method [4]
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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.
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Timepoint [4]
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Before and 21 days after the second vaccination
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Primary outcome [5]
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Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
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Assessment method [5]
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Timepoint [5]
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21 days after the first vaccination
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Primary outcome [6]
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Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
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Assessment method [6]
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Timepoint [6]
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21 days after the second vaccination
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Secondary outcome [1]
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HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
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Assessment method [1]
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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.
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Timepoint [1]
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Before and 21 days after the first vaccination
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Secondary outcome [2]
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HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
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Assessment method [2]
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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.
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Timepoint [2]
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Before and 21 days after the second vaccination
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Secondary outcome [3]
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GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
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Assessment method [3]
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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.
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Timepoint [3]
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Before and 21 days after the first vaccination
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Secondary outcome [4]
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GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
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Assessment method [4]
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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.
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Timepoint [4]
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Before and 21 days after the second vaccination
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Secondary outcome [5]
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Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
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Assessment method [5]
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Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
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Timepoint [5]
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21 days after the first vaccination
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Secondary outcome [6]
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Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
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Assessment method [6]
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Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
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Timepoint [6]
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21 days after the second vaccination
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Secondary outcome [7]
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Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
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Assessment method [7]
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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.
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Timepoint [7]
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Before and 21 days after each vaccination
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Secondary outcome [8]
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Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
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Assessment method [8]
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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).
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Timepoint [8]
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Before and 21 days after each vaccination
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Secondary outcome [9]
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GMFI in the HI Antibody Titre 180 Days After the Second Vaccination
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Assessment method [9]
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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.
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Timepoint [9]
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21 days and 180 days after the second vaccination
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Secondary outcome [10]
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Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
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Assessment method [10]
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Timepoint [10]
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180 days after the second vaccination
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Secondary outcome [11]
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Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
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Assessment method [11]
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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.
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Timepoint [11]
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From Day 0 to Day 6 after the first vaccination
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Secondary outcome [12]
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Duration of Solicited Local AEs After the First Vaccination
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Assessment method [12]
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Solicited AEs included AEs that were specifically sought for.
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Timepoint [12]
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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
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Secondary outcome [13]
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Frequency and Intensity of Solicited Local AEs After the Second Vaccination
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Assessment method [13]
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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.
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Timepoint [13]
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From Day 0 to Day 6 after the second vaccination
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Secondary outcome [14]
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Duration of Solicited Local AEs After the Second Vaccination
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Assessment method [14]
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Solicited AEs included AEs that were specifically sought for.
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Timepoint [14]
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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
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Secondary outcome [15]
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Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
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Assessment method [15]
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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.
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Timepoint [15]
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From Day 0 to Day 6 after the first vaccination
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Secondary outcome [16]
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Duration of Solicited Systemic AEs After the First Vaccination
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Assessment method [16]
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Solicited AEs included AEs that were specifically sought for.
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Timepoint [16]
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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
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Secondary outcome [17]
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Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
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Assessment method [17]
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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.
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Timepoint [17]
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From Day 0 to Day 6 after the second vaccination
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Secondary outcome [18]
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Duration of Solicited Systemic AEs After the Second Vaccination
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Assessment method [18]
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Solicited AEs included AEs that were specifically sought for.
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Timepoint [18]
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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
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Secondary outcome [19]
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Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
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Assessment method [19]
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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).
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Timepoint [19]
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Up to 180 days after the last vaccination
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Secondary outcome [20]
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Frequency and Intensity of Unsolicited AEs
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Assessment method [20]
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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.
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Timepoint [20]
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From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
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Eligibility
Key inclusion criteria
- Male or female aged >= 18 to < 65 years at the time of providing informed consent.
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Minimum age
18
Years
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Maximum age
64
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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
- 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.
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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 administering 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 2
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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
1/07/2009
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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
1/03/2010
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Sample size
Target
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Study Site - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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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
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00938639
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Director, Vaccines Clinical Development
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00938639
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