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Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00306527
First received: March 22, 2006
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.


Condition Intervention Phase
Influenza
 Biological: Cell culture derived influenza vaccine
Biological: egg-derived influenza subunit vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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 (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine [ Time Frame: Day1 to Day 7 postvaccination ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following of one dose of the cTIV or the TIV vaccine .


Secondary Outcome Measures:
  • Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine [ Time Frame: upto 6 months postvaccination ] [ Designated as safety issue: Yes ]
    To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine 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.

  • Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects [ Time Frame: Day 22 postvaccination ] [ Designated as safety issue: No ]

    The haemagglutinin inhibition(HI) antibody titer response following one 0.5ml dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as Geometric mean titers (GMTs).

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


  • Geometric Mean Ratios, After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects [ Time Frame: Day 22 postvaccination ] [ Designated as safety issue: No ]

    Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.

    The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects.


  • Percentages of Adult and Elderly Subjects Achieving HI Titers ≥40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. [ Time Frame: Day 22 postvaccination ] [ Designated as safety issue: No ]

    Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.

    European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults and >60% for elderly.


  • Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. [ Time Frame: Day 22 postvaccination ] [ Designated as safety issue: No ]

    Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived Influenza vaccine.

    Seroconversion or significant increase as per European Licensure (CHMP)criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40 for adults and ≥30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer.



Enrollment: 2235
Study Start Date: September 2005
Study Completion Date: April 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cTIV\cTIV (adults)
Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
 Biological: Cell culture derived influenza vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: cTIV\TIV (adults)
Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
 Biological: egg-derived influenza subunit vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: cTIV\cTIV (elderly)
Subjects (≥61 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
 Biological: Cell culture derived influenza vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: cTIV\TIV (elderly)
Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
 Biological: egg-derived influenza subunit vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: TIV\TIV (adults)
Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
 Biological: egg-derived influenza subunit vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: TIV\cTIV (adults)
Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
 Biological: Cell culture derived influenza vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: TIV\TIV (elderly)
Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
 Biological: egg-derived influenza subunit vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Active Comparator: TIV\cTIV (elderly)
Subjects (≥61 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
 Biological: Cell culture derived influenza vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

  Eligibility

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

Inclusion Criteria:

  1. 18 to < 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
  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. in good health as determined by:

    1. medical history related to the previous six months,
    2. physical examination,
    3. clinical judgment of the investigator.

Exclusion Criteria:

  1. unwilling or unable to give written informed consent to participate in the study
  2. currently experiencing an acute infectious disease

  3. any serious disease such as, for example:

    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
  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 expect to receive another vaccine within 3 weeks following the study vaccination
  12. participation in another clinical trial within 90 days prior to enrolment and throughout the full length of the study
  13. 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 5 days
  14. pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
  15. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306527

Locations
Poland
Wojewódzki Szpital Dzieci_cy
ul. Langiewicza 2, Kielce, Poland, 25-381
Centrum Bada_ Farmakologii Klinicznej
ul. Ujastek 3, Krakow, Poland, 30-969
NZOZ Jagiello_skie
Centrum Medyczne Sp. z o.o., o_. Jagiello_skie 1, Kraków, Poland, 31-832
NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.
Pl. Sikorskiego 6a, Kraków, Poland, 31-115
Szpital Jana Pawła II, Oddz. Neuroinfekcji
ul. Pr_dnicka 80, Kraków, Poland, 31-202
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
  More Information

Publications:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00306527     History of Changes
Other Study ID Numbers: V58P4E1, EUDRACT: 2005-001902-26
Study First Received: March 22, 2006
Results First Received: December 6, 2012
Last Updated: January 18, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Novartis:
Influenza
adult/elderly
flu cell culture
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 May 19, 2013