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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Isconova AB

ClinicalTrials.gov Identifier:

NCT01444482

First received: August 19, 2011

Last updated: September 29, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 19, 2011
Last Updated Date	September 29, 2011
Start Date ^ICMJE	May 2011
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 29, 2011)	Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M [ Time Frame: 1 - 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01444482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 29, 2011)	Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M [ Time Frame: 1 - 7 months ] [ Designated as safety issue: Yes ] Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M [ Time Frame: 1 - 7 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Parenterally Administrated Adjuvanted Seasonal Influenza Vaccine in Healthy Elderly Volunteers
Official Title ^ICMJE	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.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Influenza
Intervention ^ICMJE	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. Biological: Seasonal influenza vaccine 1 human dose of seasonal influenza vaccine
Study Arm (s)	Experimental: Matrix M adjuvanted influenza vaccine 1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M Intervention: Biological: Matrix M Active Comparator: Seasonal influenza vaccine 1 human dose of seasonal influenza vaccine Intervention: Biological: Seasonal influenza vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	110
Completion Date	Not Provided
Estimated Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	65 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Hungary

Administrative Information
NCT Number ^ICMJE	NCT01444482
Other Study ID Numbers ^ICMJE	ISC-Influenza-001
Has Data Monitoring Committee	No
Responsible Party	Isconova AB
Study Sponsor ^ICMJE	Isconova AB
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Isconova AB
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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