Influenza
Conditions
Keywords
Thiomersal-free influenza split vaccine 2003/2004, Influsplit SSW®/Fluarix™ 2003/2004, Influenza
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.
Interventions
BIOLOGICALThiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
BIOLOGICALGlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed