Back to results

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

Primary Purpose

Influenza

Status

Unknown status

Phase

Phase 1

Locations

Hungary

Study Type

Interventional

Intervention

Matrix M

Seasonal influenza vaccine

About this trial

This is an interventional basic science trial for Influenza

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Drug Reseach Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Matrix M adjuvanted influenza vaccine

Seasonal influenza vaccine

Arm Description

1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M

1 human dose of seasonal influenza vaccine

Outcomes

Primary Outcome Measures

Safety in elderly and adults given a single parenterally administrated dose of seasonal influenza vaccine adjuvanted with Matrix M

Secondary Outcome Measures

Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M

Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M

Full Information

NCT ID

NCT01444482

First Posted

August 19, 2011

Last Updated

September 29, 2011

Sponsor

Isconova AB

1. Study Identification

Unique Protocol Identification Number

NCT01444482

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Isconova AB

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Matrix M adjuvanted influenza vaccine

Arm Type

Experimental

Arm Description

1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M

Arm Title

Seasonal influenza vaccine

Arm Type

Active Comparator

Arm Description

1 human dose of seasonal influenza vaccine

Intervention Type

Biological

Intervention Name(s)

Matrix M

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Seasonal influenza vaccine

Intervention Description

1 human dose of seasonal influenza vaccine

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Immunogenicity in adults and elderly given a dose of seasonal influenza vaccine adjuvanted with Matrix M

Time Frame

1 - 7 months

Title

Immunogenicity in elderly given a dose of seasonal influenza vaccine alone or adjuvanted with Matrix M

Time Frame

1 - 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Drug Reseach Center

City

Balatonfured

ZIP/Postal Code

8231

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs