Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03

Study Overview
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Brief Summary
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This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.

Official Title
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Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years

Conditions
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Influenza

Intervention / Treatment
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* Biological: Thiomersal free trivalent influenza split vaccine 2002/2003
* Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated. The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred. Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language. Exclusion Criteria: Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period Acute disease at the beginning of the study Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests Pregnancy Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter Known allergic reactions that might have been caused by one or more ingredients of the vaccine

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Group A<br>The subjects in this group will be 18-60 years. | Biological: Thiomersal free trivalent influenza split vaccine 2002/2003<br>* Single dose, intramuscular injection<br>|
| Experimental: Group B<br>The subjects in this group will be > 60 years. | Biological: Thiomersal free trivalent influenza split vaccine 2002/2003<br>* Single dose, intramuscular injection<br>|
| Active Comparator: Group C<br>The subjects in this group will be 18-60 years. | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003<br>* Single dose, intramuscular injection<br>|
| Active Comparator: Group D<br>The subjects in this group will be > 60 years. | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003<br>* Single dose, intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well. |  | On Day 21 (± 2) after vaccination | 
| Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms |  | Within 4 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms |  | Within 30 days after vaccination | 
| Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs) |  | During the entire study period. | 
| Investigation of antibody persistence assessed by the criteria of the CHMP. |  | 11, 19, 27 weeks after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Thiomersal-free influenza split vaccine 2002/2003, Influsplit SSW®/Fluarix™ 2002/2003