Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Thiomersal free trivalent influenza split vaccine 2003/2004; Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731393

100351

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 4 patient groups

Group A

Experimental group

Description:

Subjects aged between 6 months and 3 years.

Treatment:

Biological: Thiomersal free trivalent influenza split vaccine 2003/2004

Group B

Experimental group

Description:

Subjects aged 3 to 6 years.

Treatment:

Biological: Thiomersal free trivalent influenza split vaccine 2003/2004

Group C

Active Comparator group

Description:

Subjects aged between 6 months and 3 years.

Treatment:

Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004

Group D

Active Comparator group

Description:

Subjects aged 3 to 6 years.

Treatment:

Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004