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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Thiomersal free trivalent influenza split vaccine 2002/2003

GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Thiomersal-free influenza split vaccine 2002/2003, Influsplit SSW®/Fluarix™ 2002/2003

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

The subjects in this group will be 18-60 years.

The subjects in this group will be > 60 years.

The subjects in this group will be 18-60 years.

The subjects in this group will be > 60 years.

Outcomes

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.

Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms

Secondary Outcome Measures

Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms

Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)

Investigation of antibody persistence assessed by the criteria of the CHMP.

Full Information

NCT ID

NCT00731029

First Posted

August 7, 2008

Last Updated

August 7, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00731029

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

April 2003 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Thiomersal-free influenza split vaccine 2002/2003, Influsplit SSW®/Fluarix™ 2002/2003

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

The subjects in this group will be 18-60 years.

Arm Title

Group B

Arm Type

Experimental

Arm Description

The subjects in this group will be > 60 years.

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

The subjects in this group will be 18-60 years.

Arm Title

Group D

Arm Type

Active Comparator

Arm Description

The subjects in this group will be > 60 years.

Intervention Type

Biological

Intervention Name(s)

Thiomersal free trivalent influenza split vaccine 2002/2003

Intervention Description

Single dose, intramuscular injection

Intervention Type

Biological

Intervention Name(s)

GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

Intervention Description

Single dose, intramuscular injection

Primary Outcome Measure Information:

Title

Time Frame

On Day 21 (± 2) after vaccination

Title

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 Measure Information:

Title

Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms

Time Frame

Within 30 days after vaccination

Title

Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)

Time Frame

During the entire study period.

Title

Investigation of antibody persistence assessed by the criteria of the CHMP.

Time Frame

11, 19, 27 weeks after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Clinical Trials Call Center

City

Dresden

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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