Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly

Study Overview
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Brief Summary
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A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

Detailed Description
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This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.

Official Title
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Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects

Conditions
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Influenza Vaccines

Intervention / Treatment
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* Biological: Influenza Vaccine
* Biological: Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Willing and able to give informed consent and able to adhere to all protocol required study procedures. Men and women (elderly) Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria Known to be allergic to constituents of the vaccine. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Ages Eligible for Study
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Minimum Age: 61 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose | Biological: Influenza Vaccine<br>* surface antigen, inactivated, prepared in cell cultures<br>|
| Active Comparator: 2<br>15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose | Biological: Influenza Vaccine<br>* surface antigen, inactivated, prepared in egg (influvac ®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity. |  | 3 weeks | 
| To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine. |  | 6 months | 
| To assess the safety and tolerability of the cell-derived vaccine following revaccination. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity. |  | 3 weeks | 
| To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, active-controlled, Phase 2