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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
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : September 12, 2011
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Seqirus

Tracking Information
First Submitted Date  ICMJE November 20, 2007
First Posted Date  ICMJE November 22, 2007
Results First Submitted Date  ICMJE July 8, 2011
Results First Posted Date  ICMJE September 12, 2011
Last Update Posted Date November 21, 2017
Study Start Date  ICMJE March 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
Incidence of Laboratory Confirmed Influenza A/B infection [ Time Frame: Timeframe: until 30 November 2008 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2011)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
Incidence of Influenza Like Illness, Immune response, Safety [ Time Frame: Incidence of Influenza Like Illness (until 30 November 2008), Immune response (21 days); Safety (approximately 7 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: CSL Limited Influenza Vaccine
    A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: CSL Limited Influenza Vaccine
  • 2
    Intervention: Biological: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2007)
7500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00562484
Other Study ID Numbers  ICMJE CSLCT-USF-06-28
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seqirus
Study Sponsor  ICMJE Seqirus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Director Vaccines Seqirus
PRS Account Seqirus
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP