Influenza
Conditions
Brief summary
This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.
Interventions
BIOLOGICALCSL Limited Influenza Vaccine
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
BIOLOGICALPlacebo
Placebo
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination * Non pregnant/ non lactating females
Exclusion criteria
* Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines * Vaccination against influenza in the previous 6 months * Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality * Known history of Guillain-Barré Syndrome; * Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC. * History of neurological disorders or seizures * Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder * Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids * Administration of immunoglobulins and/or any blood products; * Participation in a clinical trial or use of an investigational compound; * Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior; * Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection | 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009 | Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Influenza-like Illness (ILI) | 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009 | The criteria for the protocol defined ILI were as follows: * At least one respiratory symptom: * cough, sore throat or nasal congestion * And at least one systemic symptom: * fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches. The CDC ILI case definition was the occurrence of fever (100°F \[37.8°C\] or higher) in conjunction with either cough or sore throat. |
| Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | 21 days after study vaccination | — |
| Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | 21 days after study vaccination | — |
| Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | 21 days after study vaccination | Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. |
| Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | 21 days after study vaccination | Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. |
| CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains | 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009 | Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate. |
| Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | 21 days after study vaccination | Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination. |
| Frequency and Intensity of Local and Systemic Solicited Symptoms | 5 days after study vaccination | Adverse event grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. Fever Grade 1: ≥ 37.7°C - \< 38.0°C (≥ 99.9 - \< 100.4°F) Grade 2: ≥ 38.0°C - \< 39.0°C (≥ 100.4 - \< 102.2°F) Grade 3: ≥ 39.0°C (\> 102.2°F) |
| Frequency and Intensity of Unsolicited Adverse Events (UAEs) | 21 days after study vaccination | UAE grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. |
| Serious Adverse Events (SAEs) | 180 days after study vaccination | An SAE was any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required an unexpected in-participant hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability / incapacity; * Was a congenital anomaly / birth defect; and / or * Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out |
| New Onsets of Chronic Illness (NOCI) | 180 days after study vaccination | An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension). |
| Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | 21 days after study vaccination | Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination. |
Countries
Australia, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSL's IVV Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV | 10,033 |
| Placebo Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season | 5,011 |
| Total | 15,044 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 1 |
| Overall Study | Lost to Follow-up | 132 | 71 |
| Overall Study | Moved away from the study area | 20 | 9 |
| Overall Study | Protocol Violation | 11 | 2 |
| Overall Study | Reason not provided or not specified | 25 | 12 |
| Overall Study | Withdrawal by Subject | 12 | 9 |
Baseline characteristics
| Characteristic | CSL's IVV | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10033 Participants | 5011 Participants | 15044 Participants |
| Age, Continuous | 35.5 years STANDARD_DEVIATION 14.69 | 35.4 years STANDARD_DEVIATION 14.69 | 35.5 years STANDARD_DEVIATION 14.69 |
| Region of Enrollment Australia | 8201 participants | 4090 participants | 12291 participants |
| Region of Enrollment New Zealand | 1832 participants | 921 participants | 2753 participants |
| Sex: Female, Male Female | 5523 Participants | 2667 Participants | 8190 Participants |
| Sex: Female, Male Male | 4510 Participants | 2344 Participants | 6854 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3,028 / 10,015 | 1,549 / 5,005 |
| serious Total, serious adverse events | 100 / 10,015 | 44 / 5,005 |
Outcome results
Primary
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.
Time frame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSL's IVV | CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection | 2.24 Ratio |
| Placebo | CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection | 3.87 Ratio |
Comparison: Vaccine efficacy = 100 x (1 - ratio of incidence rate)95% CI: [30, 52]
Secondary
CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains
Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate.
Time frame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSL's IVV | CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains | 0.59 Ratio |
| Placebo | CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains | 1.47 Ratio |
Comparison: Vaccine efficacy = 100 x (1 - ratio of incidence rate)95% CI: [44, 72]
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms
Adverse event grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. Fever Grade 1: ≥ 37.7°C - \< 38.0°C (≥ 99.9 - \< 100.4°F) Grade 2: ≥ 38.0°C - \< 39.0°C (≥ 100.4 - \< 102.2°F) Grade 3: ≥ 39.0°C (\> 102.2°F)
Time frame: 5 days after study vaccination
Population: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 redness | 3 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any myalgia | 2150 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any fever | 258 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 myalgia | 33 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any chills | 509 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 nausea | 22 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any vomiting | 83 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any tenderness | 6956 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 vomiting | 10 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 fever | 8 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any local solicited symptom | 7474 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any swelling / induration | 433 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any pain | 4850 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 pain | 19 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any redness | 362 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any headache | 2553 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any bruising | 135 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 tenderness | 30 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 bruising | 1 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 headache | 43 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 swelling / induration | 6 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 chills | 17 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any malaise | 2916 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any nausea | 678 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any systemic solicited symptom | 4670 Participants |
| CSL's IVV | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 malaise | 67 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 nausea | 16 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any pain | 539 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 pain | 0 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any tenderness | 874 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 tenderness | 2 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any redness | 18 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 redness | 0 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any swelling / induration | 20 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any systemic solicited symptom | 1955 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any fever | 93 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 fever | 2 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any headache | 1176 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 headache | 19 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any malaise | 1277 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 malaise | 24 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any myalgia | 609 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any vomiting | 38 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 vomiting | 4 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any local solicited symptom | 1021 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 swelling / induration | 0 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any bruising | 29 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 bruising | 0 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any chills | 187 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 chills | 3 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Any nausea | 287 Participants |
| Placebo | Frequency and Intensity of Local and Systemic Solicited Symptoms | Grade 3 myalgia | 5 Participants |
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Time frame: 21 days after study vaccination
Population: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants with at least one UAE | 3519 Participants |
| CSL's IVV | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 1 UAE | 1604 Participants |
| CSL's IVV | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 2 UAE | 1536 Participants |
| CSL's IVV | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 3 UAE | 378 Participants |
| Placebo | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 3 UAE | 162 Participants |
| Placebo | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants with at least one UAE | 1698 Participants |
| Placebo | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 2 UAE | 784 Participants |
| Placebo | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 1 UAE | 750 Participants |
Secondary
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Time frame: 21 days after study vaccination
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | H1N1 (A/Solomon Islands/3/2006) | 21 Fold increase |
| CSL's IVV | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | H3N2 (A/Brisbane/10/2007) | 18 Fold increase |
| CSL's IVV | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | B (B/Brisbane/3/2007) | 8 Fold increase |
| Placebo | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | H1N1 (A/Solomon Islands/3/2006) | 1 Fold increase |
| Placebo | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | H3N2 (A/Brisbane/10/2007) | 1 Fold increase |
| Placebo | Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008 | B (B/Brisbane/3/2007) | 1 Fold increase |
Secondary
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Time frame: 21 days after study vaccination
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | H1N1 (A/Brisbane/59/2007) | 13 Fold increase |
| CSL's IVV | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | H3N2 (A/Uruguay/2007) | 15 Fold increase |
| CSL's IVV | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | B (B/Florida/4/2006) | 6 Fold increase |
| Placebo | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | B (B/Florida/4/2006) | 1 Fold increase |
| Placebo | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | H1N1 (A/Brisbane/59/2007) | 1 Fold increase |
| Placebo | Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009 | H3N2 (A/Uruguay/2007) | 1 Fold increase |
Secondary
Incidence of Influenza-like Illness (ILI)
The criteria for the protocol defined ILI were as follows: * At least one respiratory symptom: * cough, sore throat or nasal congestion * And at least one systemic symptom: * fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches. The CDC ILI case definition was the occurrence of fever (100°F \[37.8°C\] or higher) in conjunction with either cough or sore throat.
Time frame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Incidence of Influenza-like Illness (ILI) | Laboratory-confirmed ILI (CDC definition) | 0.9 Percentage of participants |
| CSL's IVV | Incidence of Influenza-like Illness (ILI) | Reported ILI (protocol definition) | 11.9 Percentage of participants |
| CSL's IVV | Incidence of Influenza-like Illness (ILI) | Culture-confirmed ILI | 1.5 Percentage of participants |
| CSL's IVV | Incidence of Influenza-like Illness (ILI) | Reported ILI (CDC definition) | 2.6 Percentage of participants |
| Placebo | Incidence of Influenza-like Illness (ILI) | Laboratory-confirmed ILI (CDC definition) | 1.7 Percentage of participants |
| Placebo | Incidence of Influenza-like Illness (ILI) | Culture-confirmed ILI | 2.4 Percentage of participants |
| Placebo | Incidence of Influenza-like Illness (ILI) | Reported ILI (CDC definition) | 3.6 Percentage of participants |
| Placebo | Incidence of Influenza-like Illness (ILI) | Reported ILI (protocol definition) | 13.5 Percentage of participants |
Secondary
New Onsets of Chronic Illness (NOCI)
An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).
Time frame: 180 days after study vaccination
Population: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | New Onsets of Chronic Illness (NOCI) | Number of participants with at least one NOCI | 80 Participants |
| CSL's IVV | New Onsets of Chronic Illness (NOCI) | Number of participants with related NOCI | 3 Participants |
| Placebo | New Onsets of Chronic Illness (NOCI) | Number of participants with at least one NOCI | 46 Participants |
| Placebo | New Onsets of Chronic Illness (NOCI) | Number of participants with related NOCI | 0 Participants |
Secondary
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
Time frame: 21 days after study vaccination
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | H3N2 (A/Brisbane/10/2007) | 97 Percentage of participants |
| CSL's IVV | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | B (B/Brisbane/3/2007) | 77 Percentage of participants |
| CSL's IVV | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | H1N1 (A/Solomon Islands/3/2006) | 99 Percentage of participants |
| Placebo | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | H1N1 (A/Solomon Islands/3/2006) | 42 Percentage of participants |
| Placebo | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | H3N2 (A/Brisbane/10/2007) | 35 Percentage of participants |
| Placebo | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008 | B (B/Brisbane/3/2007) | 13 Percentage of participants |
Secondary
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
Time frame: 21 days after study vaccination
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | H1N1 (A/Brisbane/59/2007) | 94 Percentage of participants |
| CSL's IVV | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | H3N2 (A/Uruguay/2007) | 94 Percentage of participants |
| CSL's IVV | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | B (B/Florida/4/2006) | 89 Percentage of participants |
| Placebo | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | H1N1 (A/Brisbane/59/2007) | 36 Percentage of participants |
| Placebo | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | H3N2 (A/Uruguay/2007) | 43 Percentage of participants |
| Placebo | Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 | B (B/Florida/4/2006) | 30 Percentage of participants |
Secondary
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Time frame: 21 days after study vaccination
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | H3N2 (A/Brisbane/10/2007) | 87 Percentage of participants |
| CSL's IVV | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | B (B/Brisbane/3/2007) | 63 Percentage of participants |
| CSL's IVV | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | H1N1 (A/Solomon Islands/3/2006) | 81 Percentage of participants |
| Placebo | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | H3N2 (A/Brisbane/10/2007) | 1 Percentage of participants |
| Placebo | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | B (B/Brisbane/3/2007) | 1 Percentage of participants |
| Placebo | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 | H1N1 (A/Solomon Islands/3/2006) | 1 Percentage of participants |
Secondary
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Time frame: 21 days after study vaccination
Population: Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | H1N1 (A/Brisbane/59/2007) | 78 Percentage of participants |
| CSL's IVV | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | H3N2 (A/Uruguay/2007) | 81 Percentage of participants |
| CSL's IVV | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | B (B/Florida/4/2006) | 61 Percentage of participants |
| Placebo | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | H3N2 (A/Uruguay/2007) | 1 Percentage of participants |
| Placebo | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | B (B/Florida/4/2006) | 0 Percentage of participants |
| Placebo | Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009 | H1N1 (A/Brisbane/59/2007) | 1 Percentage of participants |
Secondary
Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required an unexpected in-participant hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability / incapacity; * Was a congenital anomaly / birth defect; and / or * Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out
Time frame: 180 days after study vaccination
Population: Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL's IVV | Serious Adverse Events (SAEs) | Number of participants with at least one SAE | 100 Participants |
| CSL's IVV | Serious Adverse Events (SAEs) | Number rof participants with related SAE | 0 Participants |
| Placebo | Serious Adverse Events (SAEs) | Number of participants with at least one SAE | 44 Participants |
| Placebo | Serious Adverse Events (SAEs) | Number rof participants with related SAE | 0 Participants |