Two-site Intradermal Influenza Vaccination in Elderly

Study Overview
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Brief Summary
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One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.

Detailed Description
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The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. Check for HA Antibody

Official Title
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Two-site Intradermal Influenza Vaccination in Elderly

Conditions
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Influenza

Intervention / Treatment
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* Biological: seasonal influenza vaccine
* Biological: seasonal influenza vaccine
* Biological: seasonal influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male or female volunteer aged at least 60 years old willing to participate in this study Exclusion Criteria: previous influenza vaccination within 6 months systemic ypersensitivity to egg or chicken proteins or any of the vaccine components history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents. ongoing acute febrile illness (oral temperature, ≥37.5 c ) congenital or acquired immunodeficiency treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months long-term treatment with systemic corticosteroids receipt of blood or blood-derived products in the previous 3 months history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain | Biological: seasonal influenza vaccine<br>* receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain<br>* Other names: lot no 0700302A;|
| Experimental: group 2<br>receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site | Biological: seasonal influenza vaccine<br>* receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group<br>* Other names: lot no 0700302A;|
| Experimental: group 3<br>receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site | Biological: seasonal influenza vaccine<br>* receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site<br>* Other names: lot no 0700302A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity | evaluate the immunogenicity of the two-site intradermal influenza vaccination containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age , as measured by the titer of hemagglutination inhibition (HAI) antibodies, in order to determine whether it would meet the guidelines of the European Committee for Proprietary Medicinal Products (CPMP) for the annual relicensure of influenza vaccines | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of the immunogenicity | comparison of the immunogenicity of the two-site influenza vaccine administered intradermally as the above reduced dose with those of the reference influenza vaccine administered intramuscularly at the standard dose | 4 months | 
| safety | evaluate for number of participants with adverse effects: systemic effects such as fever, headache, myalgia local effects such as redness, swelling, induration and pain by giving diary card for each participant to record the data once daily for 1 week. (the investigators explain how to grade the redness (no/yes), swelling by measure, induration by measure, pain (no/yes)) | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, aged, intradermal injection