Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00511914
First received: August 3, 2007
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects


Condition Intervention Phase
Seasonal Influenza Vaccine
Biological: cTIV
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture, Using the Strain Composition 2007/2008, When Administered to Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV). [ Time Frame: 3 weeks postvaccination (Day 22) ] [ Designated as safety issue: No ]
    Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.

  • Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV) [ Time Frame: 3 weeks postvaccination (Day 22) ] [ Designated as safety issue: No ]

    Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.

    The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects.


  • Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV). [ Time Frame: 3 weeks postvaccination (Day 22) ] [ Designated as safety issue: No ]

    HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.

    This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects.


  • Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV). [ Time Frame: 3 weeks postvaccination (Day 22) ] [ Designated as safety issue: No ]

    Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).

    According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects.



Secondary Outcome Measures:
  • Number of Subjects Reporting Local and Systemic Reactions [ Time Frame: 3 days postvaccination ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.


Enrollment: 135
Study Start Date: July 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cTIV (Adults)
Received one dose of cell-culture derived trivalent influenza vaccine (cTIV).
Biological: cTIV
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle
Experimental: cTIV (Elderly)
Received one dose of cell-culture derived trivalent influenza vaccine (cTIV).
Biological: cTIV
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects eligible for enrollment into this study are male and female adults who were:

  1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
  2. available for all the visits scheduled in the study and able to comply with all study requirements
  3. in good health as determined by:

    • medical history
    • physical examination
    • clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained.

Exclusion Criteria:

Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:

  1. Any serious chronic or acute disease such as:

    1. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
    2. Congestive heart failure
    3. Advanced arteriosclerotic disease
    4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.
    5. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
    6. Insulin dependent diabetes mellitus
    7. Acute or progressive hepatic disease
    8. Acute or progressive renal disease
    9. Severe neurological or psychiatric disorder
  2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances
  3. Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:

    1. Receipt of immunosuppressive therapy (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study,
    2. Receipt of immunostimulants,
    3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
    4. Suspected or known HIV infection or HIV-related disease.
  4. Known or suspected history of drug or alcohol abuse
  5. Bleeding diathesis or receive anticoagulants of the coumarin type
  6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days)
  7. Influenza immunization or laboratory confirmed influenza within the last 6 months and more than one influenza immunization within the past 12 months
  8. Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start
  9. Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
  10. Fever (i.e. body temperature ≥ 38.0°C) within the past 3 days prior to study entry
  11. Simultaneous participation in another clinical study
  12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
  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: NCT00511914

Locations
Germany
Betriebsaerztlicher Dienst, Standort Marburg
Baldingerstrasse, Marburg Hessen, Germany, 35033
Z29, Blutspendezentrale, Gebaude Z29, Behringwerke
Emil-von-Behring-Str. 76, Marburg, Germany, 35041
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00511914     History of Changes
Other Study ID Numbers: V58P1S, 2007-001404-20
Study First Received: August 3, 2007
Results First Received: December 10, 2012
Last Updated: January 18, 2013
Health Authority: Germany: Paul-Ehrlich-Institute

Keywords provided by Novartis:
Influenza vaccine

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 20, 2014