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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00841646
First received: February 10, 2009
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Prepandemic Influenza Vaccine
Biological: Monovalent inactivated influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 343
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Biological: Monovalent inactivated influenza vaccine
2 doses of monovalent inactivated influenza vaccine with adjuvant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841646

Locations
Hungary
Pestlőrinc-Pestszentimre Egészségügyi Szolgáltató KFT
Budapest, Hungary, 1183
Bács-Kiskun Megyei Kórház Tüdőgondozó Intézet
Kecskemét, Hungary, 6000
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00841646     History of Changes
Other Study ID Numbers: V87P11, 2008-000895-25
Study First Received: February 10, 2009
Last Updated: December 7, 2011
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Novartis:
Influenza 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 April 17, 2014