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NCT Number: NCT00586469

A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.

Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.

Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.

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Key information

Conditions

Influenza Vaccines Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Coquitlam, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • Male and female adults, 18 to 60 years.
  • Written informed consent obtained from the subject.
  • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.

Exclusion criteria

  • Acute disease at the time of enrollment.
  • Any confirmed or suspected immunosuppressive condition
  • Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • A history of any demyelinating disease including Guillain-Barré syndrome.
  • Presence of an active neurological disorder.
  • Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
  • Receipt of an influenza vaccine within 6 months prior to study enrollment.
  • Administration of any vaccines within 30 days prior to study enrollment or during the study period.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
  • A history of severe adverse reaction to a previous influenza vaccination.
  • Lactating/nursing female.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Treatment and study plan

Fluviral

Biological

One dose, Intramuscular injection

Primary outcomes

  1. Geometric Mean Titers (GMTs) of Anti-H3 and B Strains

    Time frame: At Day 21

    GMTs for H1 strain is addressed as a secondary endpoint

Secondary outcomes

  1. Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains

    Time frame: At Days 0 and 21

    The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)

  2. Number of Participants Who Seroconverted.

    Time frame: At Day 21.

    The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.

  3. Number of Seroprotected Participants.

    Time frame: At Days 0 and 21

    The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.

  4. Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1

    Time frame: At Day 21 compared to Day 0

    Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.

  5. The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B

    Time frame: At Day 21 compared to Day 0

    The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table. The "fold increase" corresponds to the Unit of Measure "Factor."

  6. Number of Participants Reporting Solicited Local Symptoms

    Time frame: During the 4-day follow up period following vaccination.

    Solicited local symptoms assessed include pain, redness and swelling.

  7. Number of Participants Reporting Solicited General Symptoms

    Time frame: During the 4-day period following each vaccination.

    Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face

  8. Number of Participants Reporting Unsolicited Adverse Events (AE).

    Time frame: During the 21-day period following each vaccination.

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  9. Number of Participants Reporting Serious Adverse Events (SAE)

    Time frame: Within 21 days after vaccination

    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 4, 2008
Registry last updated
Jun 27, 2019

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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