Clinical trial NCT00841646: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prepandemic Influenza Vaccine
Keywords: Influenza vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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;

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Pestlőrinc-Pestszentimre Egészségügyi Szolgáltató KFT
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Kórház Tüdőgondozó Intézet
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Bihari I, Panczel 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.