MedDataX Logo

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

NCT ID: NCT00731029

Last Updated: 2008-08-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type EXPERIMENTAL

Thiomersal free trivalent influenza split vaccine 2002/2003

Intervention Type BIOLOGICAL

Single dose, intramuscular injection

Group B

The subjects in this group will be \> 60 years.

Group Type EXPERIMENTAL

Thiomersal free trivalent influenza split vaccine 2002/2003

Intervention Type BIOLOGICAL

Single dose, intramuscular injection

Group C

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

Single dose, intramuscular injection

Group D

The subjects in this group will be \> 60 years.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

Single dose, intramuscular injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thiomersal free trivalent influenza split vaccine 2002/2003

Single dose, intramuscular injection

Intervention Type BIOLOGICAL

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

Single dose, intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GSK Biologicals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Clinical Trials Call Center

Dresden, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

218352/053

Identifier Type: -

Identifier Source: org_study_id