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Completed

NCT Number: NCT00310804

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

2nd Department of Internal Diseases, Panevezys Hospital,, Panevezys, Lithuania

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 to <61 years of age
  • mentally competent to understand the nature, the scope and the consequences of the study
  • able and willing to give written informed consent prior to study entry
  • in good health as determined by:
  • medical history,
  • physical examination,
  • clinical judgment of the Investigator.

Exclusion criteria

  • unwilling or unable to give written informed consent to participate in the study
  • participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
  • currently experiencing an acute infectious disease
  • any serious disease, such as, for example:
  • cancer,
  • autoimmune disease (including rheumatoid arthritis),
  • advanced arteriosclerotic disease or complicated diabetes mellitus,
  • chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
  • acute or progressive hepatic disease,
  • acute or progressive renal disease,
  • congestive heart failure
  • surgery planned during the study period
  • bleeding diathesis
  • history of hypersensitivity to any component of the study medication or chemically related substances
  • history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
  • known or suspected impairment/alteration of immune function, for example resulting from:
  • receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
  • receipt of immunostimulants,
  • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
  • high risk for developing an immunocompromising disease
  • history of drug or alcohol abuse
  • laboratory-confirmed influenza disease within 6 months prior to Visit 1
  • receipt of influenza vaccine within 6 months prior to Visit 1
  • receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
  • any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
  • if female, pregnant or breastfeeding
  • if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
  • planned relocation abroad during the study period
  • any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Treatment and study plan

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)

Biological

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)

Biological

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)

Biological

One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3

Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)

Biological

One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

Primary outcomes

  1. Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects

    Time frame: Day 22 postvaccination

    The haemagglutinin Inhibition (HI) antibody titer response following

    • one dose of cTIV for each of the three lots separately and
    • one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).

    The HI GMTs were evaluated using egg-derived antigen assay.

  2. Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects

    Time frame: Day 22 postvaccination

    Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following

    • one dose of cTIV for each of the three vaccine lots separately and
    • for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

    The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.

  3. Percentage of Subjects With HI Titers ≥40

    Time frame: Day 22 postvaccination

    Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after

    • one dose of cTIV for each of the three vaccine lots separately and
    • for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

    European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.

  4. Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine

    Time frame: Day 22 postvaccination

    Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after

    • one dose of cTIV for each of the three vaccine lots separately and
    • one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

    European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.

    As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

Secondary outcomes

  1. Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.

    Time frame: Day 1 to Day 7 postvaccination

    To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of

    • one dose of cTIV for each of the three vaccine lots separately and
    • for one dose of cTIV (combined) compared to TIV.
  2. Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine

    Time frame: Day 1 - Day 181 postvaccination

    Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Apr 5, 2006
Registry last updated
Aug 15, 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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