Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine

Study Overview
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Brief Summary
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Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.

Official Title
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Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Surface Antigen Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Biological: S205 placebo
* Biological: S205 10ugHA
* Biological: S205 30ugHA
* Biological: S205 10ugHA+500ugAlOH
* Biological: S205 30ugHA+500ugAlOH
* Biological: S205 10ugHA+1250ugAlOH
* Biological: S205 30ugHA+1250ugAlOH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being healthy and ≥ 18 and ≤ 49 years of age willing and able to give informed consent Exclusion Criteria: having participated in an influenza H5 vaccine trial in the past known to be allergic to any constituent of the vaccine serious adverse reactions to previous (influenza) vaccination currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study using medication that influences the immune system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Biological: S205 placebo<br>* 2 i.m. injections per subject (0.5 mL each)<br>|
| Experimental: 2<br> | Biological: S205 10ugHA<br>* 2 i.m. injections per subject (0.5 mL each)<br>|
| Experimental: 3<br> | Biological: S205 30ugHA<br>* 2 i.m. injections per subject (0.5 mL each)<br>|
| Experimental: 4<br> | Biological: S205 10ugHA+500ugAlOH<br>* 2 i.m. injections per subject (0.5 mL each)<br>|
| Experimental: 5<br> | Biological: S205 30ugHA+500ugAlOH<br>* 2 i.m. injections per subject (0.5 mL each)<br>|
| Experimental: 6<br> | Biological: S205 10ugHA+1250ugAlOH<br>* 2 i.m. injections per subject (0.5 mL each)<br>|
| Experimental: 7<br> | Biological: S205 30ugHA+1250ugAlOH<br>* 2 i.m. injections per subject (0.5 mL each)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination inhibition titers |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHMP criteria |  | one year | 
| Virus neutralization |  | one year | 
| Anti-HA antibody level kinetics |  | one year | 
| Safety |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, immunogenicity, adjuvanted pandemic vaccine