A 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)
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| ClinicalTrials.gov Identifier: NCT00562484 |
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Recruitment Status :
Completed
First Posted : November 22, 2007
Results First Posted : September 12, 2011
Last Update Posted : November 21, 2017
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Sponsor:
Seqirus
Information provided by (Responsible Party):
Seqirus
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza | Biological: CSL Limited Influenza Vaccine Biological: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 7500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 Start Date : | March 2008 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | January 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Influenza Vaccines
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Biological: CSL Limited Influenza Vaccine
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0. |
| 2 |
Biological: Placebo
Placebo |
Primary Outcome Measures :
- 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.
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 [ Time Frame: 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.
- Incidence of Influenza-like Illness (ILI) [ Time Frame: 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 [ 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 ]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 [ Time Frame: 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.
- 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 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562484
Locations
| Australia, Australian Capital Territory | |
| The Clinical Trials Unit, Canberra Hospital | |
| Canberra, Australian Capital Territory, Australia | |
| Australia, New South Wales | |
| 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 | |
| Australia, Queensland | |
| Australian Clinical Research Organisation | |
| Auchenflower, Queensland, Australia, 4066 | |
| Trialworks Clinical Research Services | |
| Brisbane, Queensland, Australia | |
| Australian Clinical Research Organisation Caboolture Clinical Research Centre | |
| Caboolture, Queensland, Australia, 4510 | |
| School of Medicine, James Cook University, Cairns Base Hospital | |
| Cairns, Queensland, Australia | |
| Gold Coast Hospital | |
| Gold Coast, Queensland, Australia | |
| Australian Clinical Research Organisation | |
| Kippa Ring, Queensland, Australia | |
| Australia, South Australia | |
| CMAX, a division of IDT Australia | |
| Adelaide, South Australia, Australia | |
| Paediatric Trials Unit, Women's and Children's Hospital | |
| Adelaide, South Australia, Australia | |
| Primary Old Port Road Medical and Dental Centre | |
| Royal Park, South Australia, Australia, 5014 | |
| Australia, Tasmania | |
| Sexual Health Service | |
| Hobart, Tasmania, Australia | |
| Australia, Victoria | |
| Barwon Health, Geelong Hospital | |
| Geelong, Victoria, Australia | |
| Emeritus Research | |
| Malvern East, Victoria, Australia | |
| Murdoch Childrens Research Institute | |
| Melbourne, Victoria, Australia | |
| Australia, Western Australia | |
| Lung Institute of Western Australia | |
| Perth, Western Australia, Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia | |
| New Zealand | |
| Auckland Clinical Studies | |
| Auckland, New Zealand | |
| 198 Youth Health Centre | |
| Christchurch, New Zealand | |
| Southern Clinical Trials | |
| Christchurch, New Zealand | |
| RMC Medical Centre | |
| Dunedin, New Zealand | |
Sponsors and Collaborators
Seqirus
Investigators
| Study Director: | Clinical Director Vaccines | Seqirus |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Seqirus |
| ClinicalTrials.gov Identifier: | NCT00562484 History of Changes |
| Other Study ID Numbers: |
CSLCT-USF-06-28 |
| First Posted: | November 22, 2007 Key Record Dates |
| Results First Posted: | September 12, 2011 |
| Last Update Posted: | November 21, 2017 |
| Last Verified: | October 2017 |
Additional relevant MeSH terms:
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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |