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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
7,500
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
Placebo
The Clinical Trials Unit, Canberra Hospital
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
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
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
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
Time frame: 21 days after study vaccination
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Canberra, Australian Capital Territory, Australia
Australian Clinical Research Organisation
Brookvale, New South Wales, Australia
Australian Clinical Research Organisation
Caringbah, New South Wales, Australia
Eastern Area Health Service, Prince of Wales Hospital
Randwick, New South Wales, Australia
National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Australian Clinical Research Organisation
Auchenflower, Queensland, Australia
Trialworks Clinical Research Services
Brisbane, Queensland, Australia
Australian Clinical Research Organisation Caboolture Clinical Research Centre
Caboolture, Queensland, Australia
School of Medicine, James Cook University, Cairns Base Hospital
Cairns, Queensland, Australia
Gold Coast Hospital
Gold Coast, Queensland, Australia
...and 14 more locations
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
Time frame: 21 days after study vaccination
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
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
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
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
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
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
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
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