This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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 Using Four Different Vaccination Schedules

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines ) Identifier:
First received: February 19, 2009
Last updated: November 30, 2016
Last verified: December 2011
The present study will evaluate the immunogenicity, 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 Subjects.

Condition Intervention Phase
Pre-pandemic Influenza Vaccine Biological: Monovalent inactivated influenza vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • Evaluation of antibody response to a monovalent inactivated influenza vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologous virus strain candidate (H5N1). [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 Subjects. [ Time Frame: 6 months ]

Enrollment: 240
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Monovalent inactivated influenza vaccine
Two doses of monovalent inactivated influenza adjuvanted vaccine


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects aged 18 to 60 years of age 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:

    • Medical history,
    • Physical examination,
    • 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:

    • cancer,
    • Autoimmune disease,
    • diabetes mellitus,
    • chronic pulmonary disease,
    • acute or progressive hepatic disease,
    • acute or progressive renal 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:

    • Receipt of immunosuppressive therapy (any corticosteroid therapy
    • Receipt of immunostimulants,
    • High risk for developing an immunocompromising disease
  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 identifier: NCT00848029

Czech Republic
Vaccination and Travel Medicine Centre
Hradec Kralove, Czech Republic, 500 03
Sponsors and Collaborators
Novartis Vaccines
  More Information

Additional Information:
Responsible Party: Novartis Vaccines Identifier: NCT00848029     History of Changes
Other Study ID Numbers: V87P12
Study First Received: February 19, 2009
Last Updated: November 30, 2016

Keywords provided by Novartis ( Novartis Vaccines ):
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on June 23, 2017