InfluenzaPhase 4CSL's IVVNCT00562484
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
A Phase 4 study testing CSL Limited Influenza Vaccine in people with Influenza, run by Seqirus at 24 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CSL Limited Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,500 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Mar 2008to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
- Non pregnant/ non lactating females
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Australia20 sites
CMAX, a division of IDT Australia
Adelaide, South Australia
Paediatric Trials Unit, Women's and Children's Hospital
Adelaide, South Australia
Australian Clinical Research Organisation
Auchenflower, Queensland, 4066
Trialworks Clinical Research Services
Brisbane, Queensland
Australian Clinical Research Organisation
Brookvale, New South Wales
Australian Clinical Research Organisation Caboolture Clinical Research Centre
Caboolture, Queensland, 4510
School of Medicine, James Cook University, Cairns Base Hospital
Cairns, Queensland
The Clinical Trials Unit, Canberra Hospital
Canberra, Australian Capital Territory
Australian Clinical Research Organisation
Caringbah, New South Wales
Barwon Health, Geelong Hospital
Geelong, Victoria
Gold Coast Hospital
Gold Coast, Queensland
Sexual Health Service
Hobart, Tasmania
Australian Clinical Research Organisation
Kippa-Ring, Queensland
Emeritus Research
Malvern East, Victoria
Murdoch Childrens Research Institute
Melbourne, Victoria
Lung Institute of Western Australia
Perth, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia
Eastern Area Health Service, Prince of Wales Hospital
Randwick, New South Wales
Primary Old Port Road Medical and Dental Centre
Royal Park, South Australia, 5014
National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead
Westmead, New South Wales
New Zealand4 sites
Auckland Clinical Studies
Auckland
198 Youth Health Centre
Christchurch
Southern Clinical Trials
Christchurch
RMC Medical Centre
Dunedin
About this study
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.
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.
- Conditions
- Influenza
- Being tested
- CSL Limited Influenza Vaccine, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL Limited Influenza VaccineBiological
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CSL Limited Influenza Vaccine |
| 2 | Other | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 21 days after study vaccination
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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).
Measured: 180 days after study vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startMar 2008
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Director Vaccines, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562484
- Sponsor's protocol ID
- CSLCT-USF-06-28
- Acronym
- CSL's IVV
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2007
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 27595443
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00562484
- Acronym / sponsor ID
- CSL's IVV / CSLCT-USF-06-28
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Posted 12 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CSL Limited Influenza Vaccine |
| 2 | Other | Biological: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
- Non pregnant/ non lactating females
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL Limited Influenza VaccineA single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0. | Biological | 1 |
| PlaceboPlacebo | Biological | 2 |
Primary outcome
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
Time frame: 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.
12 secondary outcomes
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
Time frame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Incidence of Influenza-like Illness (ILI)
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
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
Time frame: 21 days after study vaccination
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
Time frame: 21 days after study vaccination
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
Time frame: 21 days after study vaccination
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
Time frame: 21 days after study vaccination
Frequency and Intensity of Local and Systemic Solicited Symptoms
Time frame: 5 days after study vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Time frame: 21 days after study vaccination
Serious Adverse Events (SAEs)
Time frame: 180 days after study vaccination
New Onsets of Chronic Illness (NOCI)
Time frame: 180 days after study vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27595443Mcbride 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Director Vaccines study director
Seqirus
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CSL Limited Influenza Vaccine in people with Influenza, run by Seqirus at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (time frame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.