Annual Study for Fluarix Registration

Phase III Vaccination Study for Evaluation of Immunogenicity and Reactogenicity of Influsplit SSW 2004/2005 in People Age 18 or Beyond

A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influsplit SSW®

Detailed Description

Since 1998 it is common practice within the European Community, to grant new licensees for Influenza Vaccines including the actual strain composition, by realizing the EU "Mutual Recognition Procedure" The procedure foresees the clinical testing of the vaccine before approval according to the particulars in the EU-Document CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines" of the "Committee for Proprietary Medical Products (CPMP) as Sub-Organization of the "European Agency for the Evaluation of Medicinal Products". Assessment of the Immunogenicity and Reactogenicity of the in its strain composition actualized, Influenza split vaccine2004/2005 (Influenza split vaccine 2005/2006) versus the criteria of the CPMP.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Dresden, Sachsen, Germany, 01277
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01069
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01099
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01187
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01219
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.
• All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
• Written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F).
• Acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Pregnancy (exclusion by safe contraception; pregnancy test at day 0.
• Known allergic reactions, probably caused by one or more vaccine ingredients.
• Drug and/or Alcohol abusers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Investigation of the humoral immune response (haemagglutination inhibiting antibodies) in subjects

Secondary Outcome Measures

Outcome Measure
Investigation of the safety and reactogenicity in subject's age 18 or elder past application of a doses of Influenza split vaccine 2005/2006 in relation to solicited and non-solicited incidents.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: March 24, 2006
• First Posted (Estimate): March 27, 2006

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 104745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 104745
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 104745
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 104745
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 104745
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 104745
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register