Clinical trial NCT00731393: Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Thiomersal-free influenza split vaccine 2003/2004
Influsplit SSW®/Fluarix™ 2003/2004
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 157
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: On Day 21 (+- 2) after the second vaccination
Secondary outcomes:
measure: Descriptive comparison of the occurrence and severity of solicited local and general symptoms
timeFrame: Within 4 days after each vaccination
measure: Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
timeFrame: Within 30 days after each vaccination
measure: Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
timeFrame: Throughout the study
measure: GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.
timeFrame: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
Other outcomes:
Locations:
city: Buetzow
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Bischofswerda
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Coswig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: