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Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00841646
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 11, 2009
Last Update Posted Date December 1, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • Evaluation of antibody response to a monovalent inactivated flu vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologous virus strain candidate (H5N1), as measured by HI test,MN test,SRH test,on day 0,21,42 and 201 [ Time Frame: 6 months ]
  • Evaluation of safety of the monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
  • Evaluation of antibody response to a monovalent inactivated flu vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologus virus strain candidate (H5N1), as measured by HI test, MN test, SRH test, on day 0, 21, 42 and 201 [ Time Frame: 6 months ]
  • Evaluation of safety of the monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects. [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00841646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects
Official Title  ICMJE A Phase II, Open-label, Multi-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects
Brief Summary The present study will evaluate the immunogenicity, safety and tolerability of two doses of monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prepandemic Influenza Vaccine
Intervention  ICMJE Biological: Monovalent inactivated influenza vaccine
2 doses of monovalent inactivated influenza vaccine with adjuvant
Study Arms  ICMJE 1
Intervention: Biological: Monovalent inactivated influenza vaccine
Publications * Bihari I, Pánczél G, Kovacs J, Beygo J, Fragapane E. Assessment of antigen-specific and cross-reactive antibody responses to an MF59-adjuvanted A/H5N1 prepandemic influenza vaccine in adult and elderly subjects. Clin Vaccine Immunol. 2012 Dec;19(12):1943-8. doi: 10.1128/CVI.00373-12. Epub 2012 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2011)
343
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2009)
334
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects aged 18 years of age and older who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol;
  • In good health as determined by:

    1. Medical history,
    2. Physical examination,
    3. Clinical judgment of the Investigator;
  • Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for all study visits.

Exclusion Criteria:

  • Previous receipt of any H5 vaccine;
  • Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
  • Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
  • Experienced fever (defined as axillary temperature 38.0°C) within 3 days prior to Visit 1;
  • Pregnant or breastfeeding;
  • Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
  • Any serious disease, such as:

    1. Medically significant cancer,
    2. Autoimmune disease (including rheumatoid arthritis and diabetes mellitus type 1),
    3. Medically significant diabetes mellitus type 2,
    4. Medically significant chronic pulmonary disease,
    5. Medically significant acute or progressive hepatic disease,
    6. Medically significant acute or progressive renal disease;
    7. Medically significant acute or progressive neurological disease;
  • Surgery planned during the study period;
  • Bleeding diathesis;
  • Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
  • History of any neurological symptoms or signs following administration of any vaccine, or anaphylactic shock following administration of any vaccine;
  • Known or suspected impairment/alteration of immune function, for example, resulting from:

    1. Receipt of immunosuppressive therapy (any systemic corticosteroid therapy or cancer chemotherapy), Inhaled and topical steroids are allowed
    2. Receipt of immunostimulants,
    3. High risk for developing an immunocompromising disease;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00841646
Other Study ID Numbers  ICMJE V87P11
2008-000895-25
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP