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OpenTrials
Completed

NCT Number: NCT00735475

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North Central Arkansas Medical Association, Mountain Home, Arkansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
  • Written informed consent ;
  • Willingness to provide a blood sample.

Exclusion criteria

  • Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
  • Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
  • Known history of Guillain-Barré Syndrome;
  • Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
  • Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
  • History of seizures;
  • Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
  • Clinically significant history of malignancy
  • Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
  • Current immunosuppressive or immunomodulative therapy;
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
  • Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
  • Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
  • Current treatment with warfarin or other anticoagulants;
  • Major congenital defects;
  • Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
  • Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
  • History of psychiatric disorders;
  • Resident of long term care facility.

Treatment and study plan

CSL Limited Influenza Virus Vaccine (Afluria®)

Biological

A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.

US Licensed Influenza Virus Vaccine (Fluzone®)

Biological

A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.

Primary outcomes

  1. Geometric Mean Titer 21 Days After the Study Vaccination

    Time frame: 21 days after vaccination

  2. Percentage of Participants With Seroconversion 21 Days After the Study Vaccination

    Time frame: 21 days after vaccination

    Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.

Secondary outcomes

  1. Frequency and Intensity of Local and Systemic Solicited Symptoms

    Time frame: 5 days after vaccination

  2. Duration of Local and Systemic Solicited Symptoms

    Time frame: 5 days after vaccination

  3. Frequency and Intensity of Unsolicited Adverse Events (UAEs)

    Time frame: 21 days after vaccination

    Abbreviation UAE stands for Unsolicited Adverse Event.

  4. Serious Adverse Events

    Time frame: 180 days after vaccination

  5. New Onsets of Chronic Illness

    Time frame: 180 days after vaccination

    A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study title

A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2008
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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