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Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects
This study has been completed.

First Received on February 10, 2009.   Last Updated on January 7, 2010   History of Changes
Sponsor: Novartis
Collaborator: Novartis Vaccines
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00841763
  Purpose

The present study, phase III, randomized, controlled, observer-blind, multicenter study, will evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a population of ealthy adult and elderly subjects.


Condition Intervention Phase
Pandemic Influenza Disease
Biological: Interpandemic adjuvanted trivalent influenza vaccine
Biological: Investigational adjuvanted monovalent influenza vaccine
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Controlled, Observer-blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine in Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To assess the safety and tolerability profile of two doses of adjuvanted monovalent influenza vaccine; To contribute to integrate the safety database detecting rare adverse events in adult subjects and uncommon adverse events in elderly subjects. [ Time Frame: 224 days, including 6 months follow-up period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate safety and tolerability of adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine. [ Time Frame: from day 22 up to day 64 ] [ Designated as safety issue: Yes ]
  • to evaluate the immunogenicity of two doses of adjuvanted monovalent influenza vaccine in a subgroup of adult and elderly subjects. [ Time Frame: from day 22 up to day 64 ] [ Designated as safety issue: Yes ]

Enrollment: 3647
Study Start Date: October 2008
Study Completion Date: November 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Investigational adjuvanted monovalent influenza vaccine
Investigational adjuvanted monovalent influenza vaccine + 1 dose of non-adjuvanted trivalent seasonal influenza vaccine
Active Comparator: 2 Biological: Interpandemic adjuvanted trivalent influenza vaccine
Interpandemic adjuvanted trivalent influenza vaccine + 1 dose of placebo

  Eligibility

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

Inclusion Criteria:

  • Subjects 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 study visits;

Exclusion Criteria:

  • Receipt of another investigational agent within 4 weeks;
  • Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
  • Receipt of influenza vaccination for current season 2008/2009;
  • 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 7 days prior to Visit 1;
  • Pregnant or breastfeeding;
  • Females of childbearing potential who are sexually active and have not used or do not plan or refuse to use an acceptable method of birth control during the active phase of the study (at least up to three weeks after last vaccine injection);
  • Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis); diabetes mellitus type I and type II; diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas or infections; advanced arteriosclerotic disease; severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; acute or progressive hepatic disease and renal disease; congestive heart failure; Body Mass Index ≥35 kg/m2 where BMI reflects obesity and not high muscle mass;
  • History of progressive or severe neurologic disorders, of any neurological symptoms or signs, or anaphylactic shock following administration of any study vaccine;
  • Surgery planned during the study period;
  • Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccines;
  • Known or suspected impairment/alteration of immune function, for example, resulting from:

    1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy) or other immunosuppressive agents within the past 60 days and for the full length of the study;
    2. receipt of immunostimulants;
    3. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
    4. suspected or known HIV infection or HIV-related disease;
  • Receipt of non study vaccines (with the exception of post-exposure vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
  • History of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
  • Members of research staff and their relatives;
  • 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: NCT00841763

Locations
Finland
Tampere Vaccine Research Clinic (15 sites)
Tampere, Finland, 33100
Germany
20 Sites
München, Germany, 80799
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00841763     History of Changes
Other Study ID Numbers: V87P13, 2008-003871-32
Study First Received: February 10, 2009
Last Updated: January 7, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
virus
pandemic 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 February 09, 2012