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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Subjects aged between 6 months and 3 years.

Group Type EXPERIMENTAL

Thiomersal free trivalent influenza split vaccine 2003/2004

Intervention Type BIOLOGICAL

2 doses, intramuscular injection

Group B

Subjects aged 3 to 6 years.

Group Type EXPERIMENTAL

Thiomersal free trivalent influenza split vaccine 2003/2004

Intervention Type BIOLOGICAL

2 doses, intramuscular injection

Group C

Subjects aged between 6 months and 3 years.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

2 doses, intramuscular injection

Group D

Subjects aged 3 to 6 years.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

2 doses, intramuscular injection

Interventions

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Thiomersal free trivalent influenza split vaccine 2003/2004

2 doses, intramuscular injection

Intervention Type BIOLOGICAL

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

2 doses, intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Thiomersal free trivalent influenza split vaccine 2003/2004

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bützow, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Bischofswerda, Saxony, Germany

Site Status

GSK Investigational Site

Coswig, Saxony, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Study Documents

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