NCT00731393CompletedPhase 3
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
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 157
- Locations
- 13
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Months to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group A
Experimental
Subjects aged between 6 months and 3 years.
Intervention: Thiomersal free trivalent influenza split vaccine 2003/2004 (Biological)
Group B
Experimental
Subjects aged 3 to 6 years.
Intervention: Thiomersal free trivalent influenza split vaccine 2003/2004 (Biological)
Group C
Active Comparator
Subjects aged between 6 months and 3 years.
Intervention: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 (Biological)
Group D
Active Comparator
Subjects aged 3 to 6 years.
Intervention: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 (Biological)
Outcomes
Primary Outcomes
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.
Time Frame: On Day 21 (+- 2) after the second vaccination
Secondary Outcomes
- 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)
Investigators
Study Sites (13)
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