Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Thiomersal free trivalent influenza split vaccine 2002/2003; Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731029

218352/053

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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239 participants in 4 patient groups

Group A

Experimental group

Description:

The subjects in this group will be 18-60 years.

Treatment:

Biological: Thiomersal free trivalent influenza split vaccine 2002/2003

Group B

Experimental group

Description:

The subjects in this group will be \> 60 years.

Treatment:

Biological: Thiomersal free trivalent influenza split vaccine 2002/2003

Group C

Active Comparator group

Description:

The subjects in this group will be 18-60 years.

Treatment:

Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

Group D

Active Comparator group

Description:

The subjects in this group will be \> 60 years.

Treatment:

Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003