Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

Study Overview
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Brief Summary
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The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Official Title
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A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years

Conditions
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Influenza

Intervention / Treatment
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* Biological: Trivalent Influenza Vaccine
* Biological: Trivalent Influenza Vaccine + high A
* Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant
* Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant
* Biological: Trivalent Influenza Vaccine + ½ dose adjuvant
* Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant
* Biological: Trivalent Influenza Vaccine + adjuvant
* Biological: Trivalent Influenza Vaccine + high A + adjuvant
* Biological: Trivalent Influenza Vaccine intradermal dose
* Biological: Trivalent Influenza Vaccine + high A intradermal dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator. Exclusion Criteria: Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years. Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.

Ages Eligible for Study
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Minimum Age: 65 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Biological: Trivalent Influenza Vaccine<br>* 1 dose of Trivalent Influenza Vaccine<br>|
| Active Comparator: 2<br> | Biological: Trivalent Influenza Vaccine + high A<br>* 1 dose of Trivalent Influenza Vaccine with high A content<br>|
| Active Comparator: 3<br> | Biological: Trivalent Influenza Vaccine + ¼ dose adjuvant<br>* 1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant<br>|
| Active Comparator: 4<br> | Biological: Trivalent Influenza Vaccine + high A + ¼ dose adjuvant<br>* 1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant<br>|
| Active Comparator: 5<br> | Biological: Trivalent Influenza Vaccine + ½ dose adjuvant<br>* 1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant<br>|
| Active Comparator: 6<br> | Biological: Trivalent Influenza Vaccine + high A + ½ dose adjuvant<br>* 1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant<br>|
| Active Comparator: 7<br> | Biological: Trivalent Influenza Vaccine + adjuvant<br>* 1 dose of Trivalent Influenza Vaccine plus adjuvant<br>|
| Active Comparator: 8<br> | Biological: Trivalent Influenza Vaccine + high A + adjuvant<br>* 1 dose of Trivalent Influenza Vaccine with high A plus adjuvant<br>|
| Active Comparator: 9<br> | Biological: Trivalent Influenza Vaccine intradermal dose<br>* 1 dose of Trivalent Influenza Vaccine intradermal dose<br>|
| Active Comparator: 10<br> | Biological: Trivalent Influenza Vaccine + high A intradermal dose<br>* 1 intradermal dose of Trivalent Influenza Vaccine + high A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strain-specific influenza antibody titers will be used to assess Immunogenicity |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Flu, Vaccine, Intradermal, Adjuvant