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Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

NCT ID: NCT00476307

Last Updated: 2016-11-04

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-07-31

Brief Summary

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This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

Detailed Description

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Conditions

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Influenza

Keywords

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Flu vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Fluarix™/Influsplit SSW® 2007/2008

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female aged 18 years or above;
* Non-childbearing or using adequate contraception;
* Written informed consent obtained from the subject.

Exclusion Criteria

Subjects must not:

* Participate in a trial or using non-registered product;
* Use immunosuppressants, blood products, or another influenza vaccine during study;
* Have virologically confirmed influenza within 1 year;
* Have allergic or acute disease;
* Have unstabilized serious chronic disease;
* Be a lactating female.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Freital, Saxony, Germany

Site Status

Countries

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Germany

Study Documents

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Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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110221

Identifier Type: -

Identifier Source: org_study_id