Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.

Study Overview
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Brief Summary
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This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms: Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants) Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.

Detailed Description
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The consent form will be reviewed and signed by the participant prior to any study-related procedures. Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1. A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine [group A] or seasonal intramuscular influenza vaccine [group B]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.

Official Title
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Comparative Immune Response of Intradermal and Intramuscular Preparations of

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: trivalent inactivated influenza


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female aged ≥ 60 years Healthy and/or medically stable with controlled chronic medical conditions (e.g. diabetes mellitus, hypertension ) able to help oneself Exclusion criteria: Known history of systemic hypersensitivity to egg or chicken proteins or any of the vaccine components Influenza infection within the past 3 months History of Guillain Barre Syndrome (GBS) or brachial neuritis within 6 weeks of previous influenza vaccination Treatment with immunosuppressive or other immune-modifying drugs or cancer therapy within the past 6 months Any concomitant medication with aspirin Participation in other intervention study Incapacity to provide fully informed consent or be attentive to follow-up observations resulting from cognitive impairment, abuse of alcohol or drug addiction Random blood for Dextrostix more than 200 mg/dL

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: trivalent inactivated influenza (INTANZA)<br>Intradermal injection | Biological: trivalent inactivated influenza<br>* intradermal or intramuscular injection in the deltoid area.<br>|
| Active Comparator: trivalent inactivated influenza (VAXIGRIP)<br>Intramuscle injection | Biological: trivalent inactivated influenza<br>* intradermal or intramuscular injection in the deltoid area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological end point | Vaccine is able to induce a 4-fold rise of Hemagglutination inhibition antibodies 70% of vaccinees within 60 days after vaccination (according to EMA (European Medicines Agency) and CBER (Center for Biologics Evaluation and Research) guidelines) | with in 60 days post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety | To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group | 60 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trivalent inactivated influenza vaccine