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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731029
• Other study ID #: 218352/053
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2008
• Last updated: August 7, 2008
• Start date: September 2002

Study information

• Verified date: August 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich Institute
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Thiomersal free trivalent influenza split vaccine 2002/2003
Single dose, intramuscular injection
• GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003
Single dose, intramuscular injection

Locations

Country	Name	City	State
Germany	GSK Clinical Trials Call Center	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		On Day 21 (± 2) after vaccination
Primary	Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms		Within 4 days after vaccination
Secondary	Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms		Within 30 days after vaccination
Secondary	Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)		During the entire study period.
Secondary	Investigation of antibody persistence assessed by the criteria of the CHMP.		11, 19, 27 weeks after vaccination