| Primary | Seroconversion Rate 21 Days After First Study Vaccination | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. | The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21 days after the first study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | Placebo, Aged 6 months to less than 3 years | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG003 | Placebo Cohort B | Placebo, Aged 3 years to less than 9 years | | OG004 | CSL425 (7.5 mcg) Cohort B | 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | | OG005 | CSL425 (15 mcg) Cohort B | 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years |
| | Units | Counts |
|---|
| Participants | - OG00025
- OG001102
- OG00289
- OG003
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| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| - OG0004.0(0.1 to 20.4)
- OG00188.2(80.4 to 93.8)
- OG00283.1(73.7 to 90.2)
- OG003
|
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| Primary | Seroconversion Rate 21 Days After Second Study Vaccination | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. | The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21 days after the second study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | Placebo, Aged 6 months to less than 3 years | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years |
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| Secondary | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. | Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. | Posted | | Number | | Percentage of participants | | During the 7 days after each study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose |
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| Secondary | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | | Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination. | Posted | | Mean | Standard Deviation | Days | | During the 7 days after each study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose |
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| Secondary | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. | Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. | Posted | | Number | | Percentage of participants | | During the 7 days after each study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort B | | | OG001 | CSL425 (7.5 mcg) Cohort B | 7.5 mcg of hemagglutinin antigen per dose | | OG002 | CSL425 (15 mcg) Cohort B | 15 mcg of hemagglutinin antigen per dose |
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| Primary | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | | The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21 days after the first study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | Placebo, Aged 6 months to less than 3 years | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG003 | Placebo Cohort B | Placebo, Aged 3 years to less than 9 years |
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| Primary | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | | The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21 days after the second study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | Placebo, Aged 6 months to less than 3 years | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG003 | Placebo Cohort B | Placebo, Aged 3 years to less than 9 years |
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| Secondary | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | | Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination. | Posted | | Mean | Standard Deviation | Days | | During the 7 days after each study vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort B | | | OG001 | CSL425 (7.5 mcg) Cohort B | 7.5 mcg of hemagglutinin antigen per dose | | OG002 | CSL425 (15 mcg) Cohort B | 15 mcg of hemagglutinin antigen per dose |
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| Secondary | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities. | Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. | Posted | | Number | | Percentage of participants | | During the 21 days after each vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | Placebo, Aged 6 months to less than 3 years | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG003 | Placebo Cohort B | Placebo, Aged 3 years to less than 9 years |
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| Secondary | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). | Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. | Posted | | Number | | Percentage of participants | | Up to 180 days after the last vaccination | | | | ID | Title | Description |
|---|
| OG000 | Placebo Cohort A | Placebo, Aged 6 months to less than 3 years | | OG001 | CSL425 (7.5 mcg) Cohort A | 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG002 | CSL425 (15 mcg) Cohort A | 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | | OG003 | Placebo Cohort B | Placebo, Aged 3 years to less than 9 years |
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