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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Thiomersal free trivalent influenza split vaccine 2003/2004; Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004	Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	157 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
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 Start Date :	October 2003
Actual Primary Completion Date :	August 2004
Actual Study Completion Date :	August 2004

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Group A; Subjects aged between 6 months and 3 years.	Biological: Thiomersal free trivalent influenza split vaccine 2003/2004; 2 doses, intramuscular injection
Experimental: Group B; Subjects aged 3 to 6 years.	Biological: Thiomersal free trivalent influenza split vaccine 2003/2004; 2 doses, intramuscular injection
Active Comparator: Group C; Subjects aged between 6 months and 3 years.	Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004; 2 doses, intramuscular injection; Other Name: Thiomersal free trivalent influenza split vaccine 2003/2004
Active Comparator: Group D; Subjects aged 3 to 6 years.	Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004; 2 doses, intramuscular injection; Other Name: Thiomersal free trivalent influenza split vaccine 2003/2004

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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. [ Time Frame: On Day 21 (+- 2) after the second vaccination ]

Secondary Outcome Measures :

1. Descriptive comparison of the occurrence and severity of solicited local and general symptoms [ Time Frame: Within 4 days after each vaccination ]
2. Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms [ Time Frame: Within 30 days after each vaccination ]
3. Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs). [ Time Frame: Throughout the study ]
4. GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups. [ Time Frame: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	6 Months to 6 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
GSK Investigational Site
Coswig, Sachsen, Germany, 01640
GSK Investigational Site
Dresden, Sachsen, Germany, 01169
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzig, Sachsen, Germany, 04209
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 13355

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Study Protocol 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 100351
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00731393 History of Changes
Other Study ID Numbers:	100351
First Posted:	August 11, 2008
Last Update Posted:	September 15, 2016
Last Verified:	September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Thiomersal-free influenza split vaccine 2003/2004; Influsplit SSW®/Fluarix™ 2003/2004; Influenza

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections	Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs