Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Thiomersal free trivalent influenza split vaccine 2002/2003 Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003	Phase III

MedlinePlus related topics:

Flu

Drug Information available for:

Influenza Vaccines Fluvirin Thimerosal

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. [ Time Frame: On Day 21 (± 2) after vaccination ]
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms [ Time Frame: Within 4 days after vaccination ]

Secondary Outcome Measures:

Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms [ Time Frame: Within 30 days after vaccination ]
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs) [ Time Frame: During the entire study period. ]
Investigation of antibody persistence assessed by the criteria of the CHMP. [ Time Frame: 11, 19, 27 weeks after vaccination ]

Enrollment:	239
Study Start Date:	September 2002
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental The subjects in this group will be 18-60 years.	Biological: Thiomersal free trivalent influenza split vaccine 2002/2003 Single dose, intramuscular injection
Group B: Experimental The subjects in this group will be > 60 years.	Biological: Thiomersal free trivalent influenza split vaccine 2002/2003 Single dose, intramuscular injection
Group C: Active Comparator The subjects in this group will be 18-60 years.	Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 Single dose, intramuscular injection
Group D: Active Comparator The subjects in this group will be > 60 years.	Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 Single dose, intramuscular injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731029

Locations


Germany
	GSK Clinical Trials Call Center
	Dresden, Germany

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	218352/053
First Received:	August 7, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00731029
Health Authority:	Germany: Paul-Ehrlich Institute

Keywords provided by GlaxoSmithKline:

Influenza

Thiomersal-free influenza split vaccine 2002/2003

Influsplit SSW®/Fluarix™ 2002/2003

Study placed in the following topic categories:

Virus Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Influenza, Human

Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00731029