Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

Study Overview
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Brief Summary
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The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.

Official Title
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To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years

Conditions
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Influenza

Intervention / Treatment
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* Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
* Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old. All children included in the study must never have been given a prophylactic influenza inoculation. Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an 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 until 30 days after administration of the second vaccine dose. 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. Known allergic reactions that might have been caused by one or more components of the vaccine. Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 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>Subjects aged between 6 months and 3 years. | Biological: Thiomersal free trivalent influenza split vaccine 2003/2004<br>* 2 doses, intramuscular injection<br>|
| Experimental: Group B<br>Subjects aged 3 to 6 years. | Biological: Thiomersal free trivalent influenza split vaccine 2003/2004<br>* 2 doses, intramuscular injection<br>|
| Active Comparator: Group C<br>Subjects aged between 6 months and 3 years. | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004<br>* 2 doses, intramuscular injection<br>* Other names: Thiomersal free trivalent influenza split vaccine 2003/2004;|
| Active Comparator: Group D<br>Subjects aged 3 to 6 years. | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004<br>* 2 doses, intramuscular injection<br>* Other names: Thiomersal free trivalent influenza split vaccine 2003/2004;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated. |  | On Day 21 (+- 2) after the second vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive comparison of the occurrence and severity of solicited local and general symptoms |  | Within 4 days after each vaccination | 
| Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms |  | Within 30 days after each vaccination | 
| Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs). |  | Throughout the study | 
| GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups. |  | On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thiomersal-free influenza split vaccine 2003/2004, Influsplit SSW®/Fluarix™ 2003/2004, Influenza