Back to resultsA Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults (CSL's IVV)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
CSL Limited Influenza Vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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.
Sites / Locations
- The Clinical Trials Unit, Canberra Hospital
- Australian Clinical Research Organisation
- Australian Clinical Research Organisation
- Eastern Area Health Service, Prince of Wales Hospital
- National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead
- Australian Clinical Research Organisation
- Trialworks Clinical Research Services
- Australian Clinical Research Organisation Caboolture Clinical Research Centre
- School of Medicine, James Cook University, Cairns Base Hospital
- Gold Coast Hospital
- Australian Clinical Research Organisation
- CMAX, a division of IDT Australia
- Paediatric Trials Unit, Women's and Children's Hospital
- Primary Old Port Road Medical and Dental Centre
- Sexual Health Service
- Barwon Health, Geelong Hospital
- Emeritus Research
- Murdoch Childrens Research Institute
- Lung Institute of Western Australia
- Princess Margaret Hospital for Children
- Auckland Clinical Studies
- 198 Youth Health Centre
- Southern Clinical Trials
- RMC Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
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.
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.
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.
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.
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)
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.
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00562484
Brief Title
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Acronym
CSL's IVV
Official Title
A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
CSL Limited Influenza Vaccine
Intervention Description
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
Incidence of Influenza-like Illness (ILI)
Description
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
Title
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
Time Frame
21 days after study vaccination
Title
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
Time Frame
21 days after study vaccination
Title
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
Description
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
Title
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
Description
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
Title
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
Description
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
Title
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
Description
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
Title
Frequency and Intensity of Local and Systemic Solicited Symptoms
Description
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
Title
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Description
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
Title
Serious Adverse Events (SAEs)
Description
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
Title
New Onsets of Chronic Illness (NOCI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Director Vaccines
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
The Clinical Trials Unit, Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Australian Clinical Research Organisation
City
Brookvale
State/Province
New South Wales
Country
Australia
Facility Name
Australian Clinical Research Organisation
City
Caringbah
State/Province
New South Wales
Country
Australia
Facility Name
Eastern Area Health Service, Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Australian Clinical Research Organisation
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Trialworks Clinical Research Services
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Australian Clinical Research Organisation Caboolture Clinical Research Centre
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
School of Medicine, James Cook University, Cairns Base Hospital
City
Cairns
State/Province
Queensland
Country
Australia
Facility Name
Gold Coast Hospital
City
Gold Coast
State/Province
Queensland
Country
Australia
Facility Name
Australian Clinical Research Organisation
City
Kippa Ring
State/Province
Queensland
Country
Australia
Facility Name
CMAX, a division of IDT Australia
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Paediatric Trials Unit, Women's and Children's Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Primary Old Port Road Medical and Dental Centre
City
Royal Park
State/Province
South Australia
ZIP/Postal Code
5014
Country
Australia
Facility Name
Sexual Health Service
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Barwon Health, Geelong Hospital
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Emeritus Research
City
Malvern East
State/Province
Victoria
Country
Australia
Facility Name
Murdoch Childrens Research Institute
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Lung Institute of Western Australia
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Auckland Clinical Studies
City
Auckland
Country
New Zealand
Facility Name
198 Youth Health Centre
City
Christchurch
Country
New Zealand
Facility Name
Southern Clinical Trials
City
Christchurch
Country
New Zealand
Facility Name
RMC Medical Centre
City
Dunedin
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
27595443
Citation
Mcbride WJH, Abhayaratna WP, Barr I, Booy R, Carapetis J, Carson S, De Looze F, Ellis-Pegler R, Heron L, Karrasch J, Marshall H, Mcvernon J, Nolan T, Rawlinson W, Reid J, Richmond P, Shakib S, Basser RL, Hartel GF, Lai MH, Rockman S, Greenberg ME. Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial. Vaccine. 2016 Sep 22;34(41):4991-4997. doi: 10.1016/j.vaccine.2016.08.038. Epub 2016 Aug 29.
Results Reference
derived
Learn more about this trial
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
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