Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00492063
First received: June 26, 2007
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.


Condition Intervention Phase
Influenza
Biological: Cell culture-derived trivalent subunit influenza vaccine (cTIV)
Biological: Egg-derived trivalent subunit influenza vaccine (TIV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.

    In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group.


  • Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV [ Time Frame: Three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]
    Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.

  • Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV [ Time Frame: Three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.


Secondary Outcome Measures:
  • Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination [ Time Frame: Up to 7 days postvaccination ] [ Designated as safety issue: Yes ]
    The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.


Enrollment: 2654
Study Start Date: September 2004
Study Completion Date: May 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cell culture-derived influenza vaccine (cTIV) Biological: Cell culture-derived trivalent subunit influenza vaccine (cTIV)
One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
Active Comparator: Egg-derived influenza virus vaccine (TIV) Biological: Egg-derived trivalent subunit influenza vaccine (TIV)
One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was 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:

  1. 18 to 60 years of age (first age group) OR over 60 years of age (second age group)
  2. mentally competent to understand the nature, the scope and the consequences of the study
  3. able and willing to give written informed consent prior to study entry
  4. available for all the visits scheduled in the study
  5. residence in the study area
  6. in good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the investigator.

Exclusion Criteria:

  1. unable or unwilling to give written informed consent to participate in the study
  2. suffering from an acute infectious disease
  3. any serious disease such as:

    1. cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
    2. autoimmune disease (including rheumatoid arthritis),
    3. advanced arteriosclerotic disease or complicated diabetes mellitus,
    4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease,
    7. congestive heart failure
  4. surgery planned during the study period
  5. bleeding diathesis
  6. history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
  7. known or suspected impairment/alteration of immune function resulting from:

    1. receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
    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. high risk for developing an immunocompromising disease within the past 6 months
  8. history of drug or alcohol abuse
  9. laboratory confirmed influenza disease in the past 6 months
  10. received influenza vaccine within the past 6 months
  11. received another vaccine or any investigational agent within the past 60 days, or plans vaccination within 3 weeks following the study vaccination
  12. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever ≥ 38°C within the past 3 days
  13. pregnant women or women who refuse to use a reliable contraceptive method throughout the study (180 days)
  14. any condition which, in the opinion of the investigator, might 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: NCT00492063

Locations
Poland
Wojewódzki Szpital Dzieciecy
ul. Langiewicza 2, Kielce, Poland, 25-381
N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o.
os. Jagiellonskie 1, Kraków, Poland, 31-832
Praktyka Grupowa Lekarzy POZ "Familia"
Pl. Sikorskiego 6a, Kraków, Poland, 31-115
Szpital Jana Pawła II
ul. Pradnicka 80, Kraków, Poland, 31-202
Centrum Farmakologii Klinicznej
Krakow, Poland, 30-969
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications:
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00492063     History of Changes
Other Study ID Numbers: V58P4
Study First Received: June 26, 2007
Results First Received: December 11, 2012
Last Updated: January 18, 2013
Health Authority: Poland: Central Register for Clinical Trials (CEBK)

Keywords provided by Novartis:
safety
immunogenicity
non-inferiority
MDCK
cell culture-derived
subunit influenza vaccine
influenza prevention

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 July 20, 2014