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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL425 (15 mcg) | Experimental | 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 |
|
| CSL425 (30 mcg) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL425 | Biological | CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director, Vaccines Clinical Development | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Adelaide | South Australia | 5000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19745216 | Result | Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after the first vaccination |
|
For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tension headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | Seqirus | 1-855-358-8966 | Seqirus.ClinicalTrials@Seqirus.com |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| CSL425 | Biological | CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume) |
|
| 21 days after the second vaccination |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs |
| Family issues |
|
| Participant noncompliance |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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
| OG001 | 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 |
|
|
| Primary | 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. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after the second vaccination |
|
|
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| Primary | 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. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | Before and 21 days after the first vaccination |
|
|
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| Primary | 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. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | Before and 21 days after the second vaccination |
|
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| Primary | Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days after the first vaccination |
|
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| Primary | Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days after the second vaccination |
|
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| Secondary | 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. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after the first vaccination |
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| Secondary | 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. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after the second vaccination |
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| Secondary | 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. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | Before and 21 days after the first vaccination |
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| Secondary | 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. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | Before and 21 days after the second vaccination |
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| Secondary | 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. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days after the first vaccination |
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| Secondary | 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. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days after the second vaccination |
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| Secondary | 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. | The Evaluable Population comprised all randomised participants who received the first (or second, as appropriate) study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after each vaccination |
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| Secondary | 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). | The Evaluable Population comprised all randomised participants who received the study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after each vaccination |
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| Secondary | 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. | The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | 21 days and 180 days after the second vaccination |
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| Secondary | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination | The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 180 days after the second vaccination |
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| Secondary | 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. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | From Day 0 to Day 6 after the first vaccination |
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| Secondary | Duration of Solicited Local AEs After the First Vaccination | Solicited AEs included AEs that were specifically sought for. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Mean | Standard Deviation | days | 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 | 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. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | From Day 0 to Day 6 after the second vaccination |
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| Secondary | Duration of Solicited Local AEs After the Second Vaccination | Solicited AEs included AEs that were specifically sought for. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Mean | Standard Deviation | days | 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 | 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. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | From Day 0 to Day 6 after the first vaccination |
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| Secondary | Duration of Solicited Systemic AEs After the First Vaccination | Solicited AEs included AEs that were specifically sought for. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Mean | Standard Deviation | days | 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 | 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. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | From Day 0 to Day 6 after the second vaccination |
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| Secondary | Duration of Solicited Systemic AEs After the Second Vaccination | Solicited AEs included AEs that were specifically sought for. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Mean | Standard Deviation | days | 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 | 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). | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | Up to 180 days after the last vaccination |
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|
| Secondary | 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. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs |
|
|
|
| 1 |
| 120 |
| 97 |
| 120 |
| EG001 | 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 | 0 | 120 | 99 | 120 |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain at injection site | General disorders | Systematic Assessment |
|
| Redness at injection site | General disorders | Systematic Assessment |
|
| Swelling/Induration at injection site | General disorders | Systematic Assessment |
|
| Tenderness at injection site | General disorders | Systematic Assessment |
|
| Bruising at injection site | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Malaise/feeling generally unwell | General disorders | Systematic Assessment |
|
| Muscle ache (myalgia) | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Seroconversion rate - MN |
|
| Seroconversion rate - MN |
|
| GMFI - MN |
|
| GMFI - MN |
|
| Participants with MN titer ≥ 1:40 |
|
| Participants with MN titer ≥ 1:40 |
|
| After the first vaccination - MN (N = 62, 73) |
|
| After the second vaccination - MN (N = 60, 71) |
|
| After the first vaccination - MN (N = 58, 46) |
|
| After the second vaccination - MN (N = 57, 44) |
|
| Grade 3 pain at injection site |
|
| Any redness at injection site |
|
| Grade 3 redness at injection site |
|
| Any swelling/induration at injection site |
|
| Grade 3 swelling/induration at injection site |
|
| Any tenderness at injection site |
|
| Grade 3 tenderness at injection site |
|
| Any bruising at injection site |
|
| Grade 3 bruising at injection site |
|
| Swelling/induration at injection site |
|
| Tenderness at injection site |
|
| Bruising at injection site |
|
| Grade 3 pain at injection site |
|
| Any redness at injection site |
|
| Grade 3 redness at injection site |
|
| Any swelling/induration at injection site |
|
| Grade 3 swelling/induration at injection site |
|
| Any tenderness at injection site |
|
| Grade 3 tenderness at injection site |
|
| Any bruising at injection site |
|
| Grade 3 bruising at injection site |
|
| Swelling/induration at injection site |
|
| Tenderness at injection site |
|
| Bruising at injection site |
|
| Grade 3 headache |
|
| Any malaise/feeling generally unwell |
|
| Grade 3 Malaise/feeling generally unwell |
|
| Any muscle ache (myalgia) |
|
| Grade 3 muscle ache (myalgia) |
|
| Any nausea |
|
| Grade 3 nausea |
|
| Any chills |
|
| Grade 3 chills |
|
| Any vomiting |
|
| Grade 3 vomiting |
|
| Any fever |
|
| Grade 3 fever |
|
| Muscle ache (myalgia) |
|
| Nausea |
|
| Chills |
|
| Vomiting |
|
| Fever |
|
| Grade 3 headache |
|
| Any malaise/feeling generally unwell |
|
| Grade 3 Malaise/feeling generally unwell |
|
| Any muscle ache (myalgia) |
|
| Grade 3 muscle ache (myalgia) |
|
| Any nausea |
|
| Grade 3 nausea |
|
| Any chills |
|
| Grade 3 chills |
|
| Any vomiting |
|
| Grade 3 vomiting |
|
| Any fever |
|
| Grade 3 fever |
|
| Muscle ache (myalgia) |
|
| Nausea |
|
| Chills |
|
| Vomiting |
|
| Fever |
|
| At least one AESI |
|
| Related AESI |
|
| At least one NOCI |
|
| Related NOCI |
|
| Grade 2 unsolicited AEs after the first dose |
|
| Grade 3 unsolicited AEs after the first dose |
|
| All unsolicited AEs after the second dose (n=119) |
|
| Total unsolicited AEs after doses 1 & 2 |
|
| Total grade 1 unsolicited AEs after doses 1 & 2 |
|
| Total grade 2 unsolicited AEs after doses 1 & 2 |
|
| Total grade 3 unsolicited AEs after doses 1 & 2 |
|