Trial record 1 of 2 for:    A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine
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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

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00562484
First received: November 20, 2007
Last updated: August 7, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Influenza
Biological: CSL Limited Influenza Vaccine
Biological: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by CSL Limited:

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009 [ Time Frame: 21 days after study vaccination ] [ Designated as safety issue: No ]
  • Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008 [ Time Frame: 21 days after study vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 7500
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Paediatric Trials Unit, Women's and Children's Hospital
Adelaide, South Australia, Australia
CMAX, a division of IDT Australia
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
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Lung Institute of Western Australia
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
CSL Limited
Investigators
Principal Investigator: Peter Richmond, Dr Princess Margaret Hospital for Children
  More Information

No publications provided

Responsible Party: Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier: NCT00562484     History of Changes
Other Study ID Numbers: CSLCT-USF-06-28
Study First Received: November 20, 2007
Results First Received: July 8, 2011
Last Updated: August 7, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014