Study of Parenterally Administrated Adjuvanted Seasonal Influenza Vaccine in Healthy Elderly Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444482
Recruitment Status : Unknown
Verified September 2011 by Isconova AB.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2011
Last Update Posted : September 30, 2011
Information provided by (Responsible Party):
Isconova AB

Brief Summary:

The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters associated with improved protection against clinical disease in elderly. Such parameters include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune response.

Vaccination will start in 22 healthy adults receiving the investigational vaccine. Vaccination of elderly will be initiated only after demonstration of safety in adults. 88 healthy elderly volunteers will be vaccinated, 44 will receive the seasonal influenza vaccine alone and 44 will receive the investigational vaccine. Vaccines will be administrated intramuscularly in the upper arm. One dose will be administered to each volunteer included in the study. Blood samples for basic immunological assessments of cellular and humoral immunity will be taken at day 0, 7, 28, 90 and 150.

The investigational vaccine is equal to one standard human dose of a commercial seasonal influenza vaccine to which 50 µg of adjuvant Matrix M has been added.

Condition or disease Intervention/treatment Phase
Influenza Biological: Matrix M Biological: Seasonal influenza vaccine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I Single Blinded Randomised Exploratory Trial in Elderly Volunteers to Assess and Compare Safety and Immunogenicity of Adjuvanted Seasonal Influenza Vaccine (Investigational Vaccine) to Standard Seasonal Influenza Vaccine.
Study Start Date : May 2011
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Matrix M adjuvanted influenza vaccine
1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M
Biological: Matrix M
1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M, total dosage volume 0.55 mL injected intramuscularly in the upper arm once at day 0.
Active Comparator: Seasonal influenza vaccine
1 human dose of seasonal influenza vaccine
Biological: Seasonal influenza vaccine
1 human dose of seasonal influenza vaccine

Primary Outcome Measures :
  1. Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M [ Time Frame: 1 - 3 months ]

Secondary Outcome Measures :
  1. Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M [ Time Frame: 1 - 7 months ]
  2. Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M [ Time Frame: 1 - 7 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Are aged 18 to 50 years for the young adult part of the study
  • Are aged 65 to 75 years for main study
  • Have signed a voluntary written informed consent. Volunteers should be cooperative, willing and able to participate and adhere to the Protocol requirements
  • Have minimum normal standard physical performance status

Exclusion Criteria:

  • Volunteer has received seasonal Influenza vaccine of same antigenic composition within 6 months prior to enrolment
  • Volunteer having vaccine specific HI titres ≥ 40
  • Volunteer is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc
  • Volunteers who have primary or secondary immunodeficiencies (e.g. Human Immunodeficiency Virus [HIV])
  • Volunteers who have an autoimmune disease
  • Volunteer is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month of Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), are permitted
  • Volunteer has a concurrent severe or uncontrolled underlying medical disease unrelated but that is likely to compromise volunteer safety and affect the outcome of the study
  • Volunteer has a neurotoxicity (Grade ≥2)
  • Volunteer has diarrhoea (Grade ≥2)
  • Volunteer has received other vaccines, within 1 month prior to enrolment
  • Volunteer has a history of any severe or life-threatening hypersensitivity reaction
  • Volunteer has an unstable systemic disease (including active infection, uncontrolled hypertension [> 160/100], unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease)
  • Volunteer has recent history (within 6 months) of chronic alcohol or drug abuse of which may compromise the patient's safety or ability to participate in study activities
  • Volunteer has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions
  • Volunteer is currently enrolled in an investigational device or drug trial, or < 1 month since completing an investigational device or drug trial
  • Female volunteers who are pregnant or lactating (only applicable for Pre-Study)
  • Volunteer has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444482

Drug Reseach Center
Balatonfured, Hungary, 8231
Sponsors and Collaborators
Isconova AB

Responsible Party: Isconova AB Identifier: NCT01444482     History of Changes
Other Study ID Numbers: ISC-Influenza-001
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2011

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