Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
Phase 3
Completed
- Conditions
- Influenza
- Interventions
- Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
- Registration Number
- NCT00731393
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group D GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 Subjects aged 3 to 6 years. Group C GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 Subjects aged between 6 months and 3 years. Group A Thiomersal free trivalent influenza split vaccine 2003/2004 Subjects aged between 6 months and 3 years. Group B Thiomersal free trivalent influenza split vaccine 2003/2004 Subjects aged 3 to 6 years.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Berlin, Germany