Clinical trial NCT00731029: Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03
Official title: Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Thiomersal-free influenza split vaccine 2002/2003
Influsplit SSW®/Fluarix™ 2002/2003
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
* The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
* Written consent to vaccination must be available after the subjects have been briefed on the study in 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
* 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
* Pregnancy
* Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
* Known allergic reactions that might have been caused by one or more ingredients of the vaccine

Primary outcomes:
measure: GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
timeFrame: On Day 21 (± 2) after vaccination
measure: Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms
timeFrame: Within 4 days after vaccination
Secondary outcomes:
measure: Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms
timeFrame: Within 30 days after vaccination
measure: Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)
timeFrame: During the entire study period.
measure: Investigation of antibody persistence assessed by the criteria of the CHMP.
timeFrame: 11, 19, 27 weeks after vaccination
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: