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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
Study Site
Adelaide, South Australia, Australia
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.
Time frame: Before and 21 days after the first vaccination
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.
Time frame: Before and 21 days after the second vaccination
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.
Time frame: Before and 21 days after the first vaccination
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.
Time frame: Before and 21 days after the second vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Time frame: 21 days after the first vaccination
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 21 days after the second vaccination
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.
Time frame: Before and 21 days after the first vaccination
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.
Time frame: Before and 21 days after the second vaccination
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.
Time frame: Before and 21 days after the first vaccination
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.
Time frame: Before and 21 days after the second vaccination
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.
Time frame: 21 days after the first vaccination
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.
Time frame: 21 days after the second vaccination
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.
Time frame: Before and 21 days after each vaccination
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).
Time frame: Before and 21 days after each vaccination
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.
Time frame: 21 days and 180 days after the second vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
Time frame: 180 days after the second vaccination
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.
Time frame: From Day 0 to Day 6 after the first vaccination
Duration of Solicited Local AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for.
Time frame: 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
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.
Time frame: From Day 0 to Day 6 after the second vaccination
Duration of Solicited Local AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for.
Time frame: 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
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.
Time frame: From Day 0 to Day 6 after the first vaccination
Duration of Solicited Systemic AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for.
Time frame: 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
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.
Time frame: From Day 0 to Day 6 after the second vaccination
Duration of Solicited Systemic AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for.
Time frame: 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
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).
Time frame: Up to 180 days after the last vaccination
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.
Time frame: From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs